<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02229864</url>
  </required_header>
  <id_info>
    <org_study_id>10-392 B</org_study_id>
    <nct_id>NCT02229864</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions</brief_title>
  <official_title>ABSORB III RCT Pharmacokinetics (PK) Sub-study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling&#xD;
      approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB&#xD;
      III RCT (NCT01751906). The objective is to determine the pharmacokinetics of everolimus&#xD;
      delivered by the Absorb BVS in a separate and non-randomized cohort of subjects who only&#xD;
      receive Absorb BVS with a maximum of two de novo native coronary artery lesions after&#xD;
      implantation of the Absorb BVS.&#xD;
&#xD;
      Note: The ABSORB III PK subjects will not contribute to the determination of the ABSORB III&#xD;
      RCT primary endpoint.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To ensure the PK measurements reflect everolimus exposure due to Absorb BVS only, the PK&#xD;
      sub-study will not allow non-target lesion treatment.&#xD;
&#xD;
      Blood Sampling Timing:&#xD;
&#xD;
        -  Pre-Absorb BVS implantation: Baseline&#xD;
&#xD;
           o Baseline is defined as prior to implantation of the first Absorb BVS; the blood sample&#xD;
           will be drawn on the day of the index procedure either through a heparin lock, venous&#xD;
           sheath, or venipuncture.&#xD;
&#xD;
        -  Post-Absorb BVS implantation: 10 and 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 24&#xD;
           hrs (1 day), 48 hrs (2 days), 72 hrs (3 days), 96 hrs (4 days), 120 hrs (5 days), 168&#xD;
           hrs (7 days), 336 hrs (14 days), and 720 hrs (30 days).&#xD;
&#xD;
             -  Post-implantation blood samples will be drawn at the time intervals stated above;&#xD;
                timing of the post-implantation sampling will begin when the last Absorb BVS is&#xD;
                deployed, i.e. last Absorb BVS delivery catheter is removed from the body.&#xD;
&#xD;
      Pharmacokinetic (PK) parameters will include time to maximum concentration (tmax); maximum&#xD;
      concentration (Cmax); AUC24h: Area under the blood analyte concentration vs. time curve from&#xD;
      time 0 up to 24 hours post placement of the last Absorb BVS; AUClast: Area under the blood&#xD;
      analyte concentration vs. time curve from time 0 up to the last quantifiable concentration;&#xD;
      AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and&#xD;
      extrapolated to infinite time; terminal elimination rate constant (λz); terminal elimination&#xD;
      half-life (t1/2term); drug clearance (CL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Concentration (Cmax)</measure>
    <time_frame>0 to 30 days</time_frame>
    <description>Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of Maximum (Tmax)</measure>
    <time_frame>0 to 30 days</time_frame>
    <description>Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC24h</measure>
    <time_frame>0 to 24 hours</time_frame>
    <description>Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC Last</measure>
    <time_frame>0 to 30 days</time_frame>
    <description>Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-infinity</measure>
    <time_frame>0 to 30 days</time_frame>
    <description>AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).&#xD;
calculated as: AUC0-∞ = AUClast + (Clast/λz)&#xD;
The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as:&#xD;
%AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ * 100</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal Elimination Rate Constant (λz)</measure>
    <time_frame>0 to 30 days</time_frame>
    <description>The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal Elimination Half-life (t1/2term)</measure>
    <time_frame>0 to 30 days</time_frame>
    <description>The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).&#xD;
calculated as: t1/2term = 0.693/λz.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Drug Clearance (CL)</measure>
    <time_frame>0 to 30 days</time_frame>
    <description>The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).&#xD;
Calculated as: CL = Dose/AUC0 - ∞ .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Target Lesion Failure (TLF)</measure>
    <time_frame>0 to 1853 Days</time_frame>
    <description>Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All Death</measure>
    <time_frame>0 to 1853 Days</time_frame>
    <description>All death includes cardiac death, vascular death, and non-cardiac death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All Myocardial Infarction (MI)</measure>
    <time_frame>0 to 1853 Days</time_frame>
    <description>All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All Target Lesion Revascularization (TLR)</measure>
    <time_frame>0 to 1853 Days</time_frame>
    <description>All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All Target Vessel Revascularization (TVR)</measure>
    <time_frame>0 to 1853 Days</time_frame>
    <description>All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All Revascularization</measure>
    <time_frame>0 to 1853 Days</time_frame>
    <description>All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable)</measure>
    <time_frame>≤ 1 day</time_frame>
    <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable)</measure>
    <time_frame>&gt;1 to 30 days</time_frame>
    <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable)</measure>
    <time_frame>31 to 393 days</time_frame>
    <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)</measure>
    <time_frame>0 to 1853 Days</time_frame>
    <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Artery Stenosis</condition>
  <condition>Coronary Disease</condition>
  <condition>Coronary Stenosis</condition>
  <arm_group>
    <arm_group_label>Coronary artery stenting: Absorb BVS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Coronary artery stenting: Absorb BVS</intervention_name>
    <description>Scaffold diameters: 2.5, 3.0 and 3.5 mm&#xD;
Scaffold lengths: 8, 12, 18, and 28 mm</description>
    <arm_group_label>Coronary artery stenting: Absorb BVS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age.&#xD;
&#xD;
          2. Subject or a legally authorized representative must provide written Informed Consent&#xD;
             prior to any study related procedure, per site requirements.&#xD;
&#xD;
          3. Evidence of myocardial. In the absence of noninvasive ischemia, FFR must be done and&#xD;
             indicative of ischemia.&#xD;
&#xD;
          4. An acceptable candidate for coronary artery bypass graft (CABG) surgery.&#xD;
&#xD;
          5. Female subject of childbearing potential who does not plan pregnancy for up to 1 year&#xD;
             following the index procedure.&#xD;
&#xD;
          6. Female subject is not breast-feeding at the time of the screening visit and will not&#xD;
             be breast-feeding for up to 1 year following the index procedure.&#xD;
&#xD;
          7. Subject agrees to not participate in any other investigational or invasive clinical&#xD;
             study for a period of 1 year following the index procedure.&#xD;
&#xD;
        Angiographic Inclusion Criteria:&#xD;
&#xD;
          1. One or two de novo target lesions:&#xD;
&#xD;
               1. If two target lesions are present, they must be present in different epicardial&#xD;
                  vessels and both must satisfy the angiographic eligibility criteria.&#xD;
&#xD;
               2. The definition of epicardial vessels means the left anterior descending (LAD),&#xD;
                  left coronary artery (LCX), and right coronary artery (RCA) and their branches.&#xD;
                  Thus, the patient must not have lesions requiring treatment in e.g. both the LAD&#xD;
                  and a diagonal branch.&#xD;
&#xD;
          2. Target lesion(s) must be located in a native coronary artery with a visually estimated&#xD;
             or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and &lt; 100% with a&#xD;
             thrombolysis in myocardial infarction (TIMI) flow of ≥ 1 and one of the following:&#xD;
             stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve (FFR),&#xD;
             stress test), unstable angina or post-infarct angina.&#xD;
&#xD;
               1. Lesion(s) must be located in a native coronary artery with reference vessel&#xD;
                  diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.&#xD;
&#xD;
               2. Lesion(s) must be located in a native coronary artery with length by visual&#xD;
                  estimation of ≤ 24 mm.&#xD;
&#xD;
        General Exclusion Criteria:&#xD;
&#xD;
          1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an&#xD;
             Adenosine diphosphate receptor (ADP) antagonist is planned within 12 months after the&#xD;
             procedure.&#xD;
&#xD;
          2. Subject has known hypersensitivity or contraindication to device material and its&#xD;
             degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and&#xD;
             cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot&#xD;
             be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be&#xD;
             adequately pre-medicated.&#xD;
&#xD;
          3. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin;&#xD;
             or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and&#xD;
             therefore cannot be adequately treated with study medications.&#xD;
&#xD;
          4. Subject had an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of&#xD;
             the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band&#xD;
             isoenzyme (CK-MB) have not returned to within normal limits at the time of index&#xD;
             procedure; or subject with stable angina or silent ischemia has CK-MB that is greater&#xD;
             than normal limits at the time of the index procedure.&#xD;
&#xD;
          5. Subject is currently experiencing clinical symptoms consistent with new onset AMI&#xD;
             (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG&#xD;
             changes.&#xD;
&#xD;
          6. Subject has a cardiac arrhythmia as identified at the time of screening for which at&#xD;
             least one of the following criteria is met:&#xD;
&#xD;
               1. Subject requires coumadin or any other agent for chronic oral anticoagulation&#xD;
&#xD;
               2. Subject is likely to become hemodynamically unstable due to their arrhythmia&#xD;
&#xD;
               3. Subject has poor survival prognosis due to their arrhythmia&#xD;
&#xD;
          7. Subject has a left ventricular ejection fraction (LVEF) &lt; 30%&#xD;
&#xD;
          8. Subject has undergone prior percutaneous coronary intervention (PCI) within the target&#xD;
             vessel(s) during the last 12 months.&#xD;
&#xD;
          9. Subject requires future staged PCI either in target or non-target vessels or subject&#xD;
             requires future peripheral interventions &lt; 30 days after the index procedure.&#xD;
&#xD;
         10. Subject has received any solid organ transplants or is on a waiting list for any solid&#xD;
             organ transplants.&#xD;
&#xD;
         11. At the time of screening, the subject has a malignancy that is not in remission.&#xD;
&#xD;
         12. Subject is receiving immunosuppressant therapy or has known immunosuppressive or&#xD;
             severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human&#xD;
             immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are&#xD;
             not included as immunosuppressant therapy.&#xD;
&#xD;
         13. Subject has previously received or is scheduled to receive radiotherapy to a coronary&#xD;
             artery (vascular brachytherapy), or the chest/mediastinum.&#xD;
&#xD;
         14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin,&#xD;
             dabigatran, apixaban, rivaroxaban or any other agent for any reason).&#xD;
&#xD;
         15. Subject has a platelet count &lt; 100,000 cells/mm3 or &gt; 700,000 cells/mm3.&#xD;
&#xD;
         16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or&#xD;
             Child-Pugh ≥ Class B.&#xD;
&#xD;
         17. Subject has renal insufficiency as defined as an estimated glomerular filtration rate&#xD;
             (GFR) &lt; 30 ml/min/1.73m2 or dialysis at the time of screening.&#xD;
&#xD;
         18. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis&#xD;
             or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed&#xD;
             within the past six months.&#xD;
&#xD;
         19. Subject has had a cerebrovascular accident or transient ischemic neurological attack&#xD;
             (TIA) within the past six months, or any prior intracranial bleed, or any permanent&#xD;
             neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous&#xD;
             malformation, etc.).&#xD;
&#xD;
         20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath&#xD;
             insertion. Note: femoral arterial disease does not exclude the patient if radial&#xD;
             access may be used.&#xD;
&#xD;
         21. Subject has life expectancy &lt; 5 years for any non-cardiac cause or cardiac cause.&#xD;
&#xD;
         22. Subject is in the opinion of the Investigator or designee, unable to comply with the&#xD;
             requirements of the study protocol or is unsuitable for the study for any reason.&#xD;
&#xD;
         23. Subject is currently participating in another clinical trial that has not yet&#xD;
             completed its primary endpoint.&#xD;
&#xD;
         24. Subject is part of a vulnerable population&#xD;
&#xD;
        Angiographic Exclusion Criteria:&#xD;
&#xD;
        All exclusion criteria apply to the target lesion(s) or target vessel(s).&#xD;
&#xD;
          1. Lesion which prevents successful balloon pre-dilatation&#xD;
&#xD;
          2. Lesion is located in left main.&#xD;
&#xD;
          3. Aorto-ostial RCA lesion.&#xD;
&#xD;
          4. Lesion located within 3 mm of the origin of the LAD or LCX.&#xD;
&#xD;
          5. Lesion involving a bifurcation with a:&#xD;
&#xD;
               1. side branch ≥ 2 mm in diameter, or&#xD;
&#xD;
               2. side branch with either an ostial or non-ostial lesion with diameter stenosis &gt;&#xD;
                  50%, or&#xD;
&#xD;
               3. side branch requiring dilatation.&#xD;
&#xD;
          6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS.&#xD;
&#xD;
          7. Vessel contains thrombus as indicated in the angiographic images or by intravascular&#xD;
             ultrasound (IVUS) or optical coherence tomography (OCT).&#xD;
&#xD;
          8. Lesion or vessel involves a myocardial bridge.&#xD;
&#xD;
          9. Vessel has been previously treated with a stent at any time prior to the index&#xD;
             procedure such that the Absorb BVS would need to cross the stent to reach the target&#xD;
             lesion.&#xD;
&#xD;
         10. Vessel has been previously treated and the target lesion is within 5 mm proximal or&#xD;
             distal to a previously treated lesion.&#xD;
&#xD;
         11. Target lesion located within an arterial or saphenous vein graft or distal to any&#xD;
             arterial or saphenous vein graft.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David G. Rizik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scottsdale Healthcare, Scottsdale, AZ</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Louis A. Cannon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiac and Vascular Research Center of Northern Michigan Petoskey, MI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scottsdale Healthcare</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac &amp; Vascular Research Center of Northern Michigan</name>
      <address>
        <city>Petoskey</city>
        <state>Michigan</state>
        <zip>49770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <results_first_submitted>May 23, 2016</results_first_submitted>
  <results_first_submitted_qc>October 21, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 14, 2016</results_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Absorb™ BVS</keyword>
  <keyword>Angioplasty</keyword>
  <keyword>Bioabsorbable</keyword>
  <keyword>BVS</keyword>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Coronary Artery Endothelial Responsiveness</keyword>
  <keyword>Coronary artery restenosis</keyword>
  <keyword>Coronary artery stenosis</keyword>
  <keyword>Coronary scaffold</keyword>
  <keyword>Coronary Stent</keyword>
  <keyword>Drug eluting stents</keyword>
  <keyword>Everolimus</keyword>
  <keyword>Myocardial ischemia</keyword>
  <keyword>Stent thrombosis</keyword>
  <keyword>Stents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT02229864/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The first subject was enrolled on June 2, 2014 and the last subject was enrolled on September 17, 2014. The last 30-day follow-up visit occurred on October 14, 2014. Database was locked on Oct 29, 2014.</recruitment_details>
      <pre_assignment_details>In this sub-study, subjects received either one (N=8) or two (N=4) Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Coronary Artery Stenting: Absorb BVS</title>
          <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)&#xD;
Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm&#xD;
• Scaffold lengths: 8, 12, 18, and 28 mm</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The PK sub-study had slightly more male subjects, and slightly more subjects with dyslipidemia and hypertension requiring medication and subjects with stable angina as compared to ABSORB III Primary Analysis Group. The PK sub-study had fewer subjects who had undergone prior coronary intervention.</population>
      <group_list>
        <group group_id="B1">
          <title>Coronary Artery Stenting: Absorb BVS</title>
          <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)&#xD;
Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm&#xD;
• Scaffold lengths: 8, 12, 18, and 28 mm</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.1" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension Requiring Medication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dyslipidemia Requiring Medication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Coronary Intervention</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stable Angina</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Concentration (Cmax)</title>
        <description>Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).</description>
        <time_frame>0 to 30 days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Concentration (Cmax)</title>
          <description>Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>nanograms per milliliter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.397" lower_limit="1.085" upper_limit="4.460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time of Maximum (Tmax)</title>
        <description>Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).</description>
        <time_frame>0 to 30 days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Maximum (Tmax)</title>
          <description>Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" lower_limit="0.17" upper_limit="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC24h</title>
        <description>Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.</description>
        <time_frame>0 to 24 hours</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC24h</title>
          <description>Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>ng*h/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.67" lower_limit="12.09" upper_limit="44.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC Last</title>
        <description>Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.</description>
        <time_frame>0 to 30 days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC Last</title>
          <description>Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>ng*h/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.90" lower_limit="25.37" upper_limit="104.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-infinity</title>
        <description>AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).&#xD;
calculated as: AUC0-∞ = AUClast + (Clast/λz)&#xD;
The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as:&#xD;
%AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ * 100</description>
        <time_frame>0 to 30 days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-infinity</title>
          <description>AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).&#xD;
calculated as: AUC0-∞ = AUClast + (Clast/λz)&#xD;
The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as:&#xD;
%AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ * 100</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>ng*h/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.02" lower_limit="33.15" upper_limit="120.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Terminal Elimination Rate Constant (λz)</title>
        <description>The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.</description>
        <time_frame>0 to 30 days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Elimination Rate Constant (λz)</title>
          <description>The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>1/hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01092" lower_limit="0.006027" upper_limit="0.01511"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Terminal Elimination Half-life (t1/2term)</title>
        <description>The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).&#xD;
calculated as: t1/2term = 0.693/λz.</description>
        <time_frame>0 to 30 days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Elimination Half-life (t1/2term)</title>
          <description>The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).&#xD;
calculated as: t1/2term = 0.693/λz.</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.5" lower_limit="45.9" upper_limit="115.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Drug Clearance (CL)</title>
        <description>The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).&#xD;
Calculated as: CL = Dose/AUC0 - ∞ .</description>
        <time_frame>0 to 30 days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Drug Clearance (CL)</title>
          <description>The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).&#xD;
Calculated as: CL = Dose/AUC0 - ∞ .</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Liter/hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.451" lower_limit="2.421" upper_limit="5.460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Target Lesion Failure (TLF)</title>
        <description>Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).</description>
        <time_frame>0 to 1853 Days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Target Lesion Failure (TLF)</title>
          <description>Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All Death</title>
        <description>All death includes cardiac death, vascular death, and non-cardiac death.</description>
        <time_frame>0 to 1853 Days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Death</title>
          <description>All death includes cardiac death, vascular death, and non-cardiac death.</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All Myocardial Infarction (MI)</title>
        <description>All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).</description>
        <time_frame>0 to 1853 Days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Myocardial Infarction (MI)</title>
          <description>All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All Target Lesion Revascularization (TLR)</title>
        <description>All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).</description>
        <time_frame>0 to 1853 Days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Target Lesion Revascularization (TLR)</title>
          <description>All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All Target Vessel Revascularization (TVR)</title>
        <description>All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).</description>
        <time_frame>0 to 1853 Days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Target Vessel Revascularization (TVR)</title>
          <description>All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All Revascularization</title>
        <description>All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.</description>
        <time_frame>0 to 1853 Days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Revascularization</title>
          <description>All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable)</title>
        <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
        <time_frame>≤ 1 day</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable)</title>
          <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable)</title>
        <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
        <time_frame>&gt;1 to 30 days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable)</title>
          <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable)</title>
        <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
        <time_frame>31 to 393 days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable)</title>
          <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)</title>
        <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
        <time_frame>0 to 1853 Days</time_frame>
        <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Coronary Artery Stenting: Absorb BVS</title>
            <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).&#xD;
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)</title>
          <description>Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.&#xD;
Timings:&#xD;
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: &gt;24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: &gt;1 year post stent implantation</description>
          <population>ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Coronary Artery Stenting: Absorb BVS</title>
          <description>Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)&#xD;
Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm&#xD;
• Scaffold lengths: 8, 12, 18, and 28 mm</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ANGINA PECTORIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ANGINA PECTORIS AGGRAVATED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION AGGRAVATED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>NON STEMI</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>STABLE ANGINA PECTORIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>UNSTABLE ANGINA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>SMALL BOWEL OBSTRUCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>UPPER GASTROINTESTINAL BLEEDING</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHEST PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CHEST PAIN (NON-CARDIAC)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CELLULITIS OF LEG</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>CORONARY ARTERY RESTENOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>IN-STENT CORONARY ARTERY RESTENOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>SPINAL COMPRESSION FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>LUMBAR SPINAL STENOSIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>PAINFULL ARM</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>SPINAL STENOSIS OF LUMBAR REGION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE ON CHRONIC RENAL FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ACUTE RENAL FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>BENIGN PROSTATIC HYPERTROPHY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>PULMONARY EDEMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>POPLITEAL VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ANGINA PECTORIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ANGINA PECTORIS AGGRAVATED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION AGGRAVATED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>BRADYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CHEST PAIN - CARDIAC</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CONGESTIVE HEART FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CORONARY ARTERY DISSECTION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CORONARY NO-REFLOW PHENOMENON</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>NON STEMI</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>STABLE ANGINA PECTORIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>UNSTABLE ANGINA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>HEARTBURN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>SMALL BOWEL OBSTRUCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>TOOTHACHE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>UPPER GASTROINTESTINAL BLEEDING</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHEST PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CHEST PAIN (NON-CARDIAC)</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>INFUSION SITE HEMATOMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CELLULITIS OF LEG</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>BRUISE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CORONARY ARTERY RESTENOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>IN-STENT CORONARY ARTERY RESTENOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>POST PROCEDURAL MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>POSTOPERATIVE HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>SPINAL COMPRESSION FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>TICK BITE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>URINARY RETENTION POSTOPERATIVE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>CARDIAC ENZYMES INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>CREATINE KINASE MB INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>BACK PAIN AGGRAVATED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>COSTOCHONDRITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>LUMBAR SPINAL STENOSIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>MONOARTHRITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL CHEST PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>PAINFUL L ARM</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>SPINAL STENOSIS OF LUMBAR REGION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>SCIATICA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE ON CHRONIC RENAL FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ACUTE RENAL FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>URINARY RETENTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>BENIGN PROSTATIC HYPERTROPHY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>HYPOXIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>OBSTRUCTIVE SLEEP APNEA SYNDROME</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>PULMONARY EDEMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>SHORTNESS OF BREATH</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>POPLITEAL VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>SLOW REFLOW PHENOMENON</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Principal Investigators shall not present or publish, nor submit for publication, any work resulting from the Services without Sponsor's prior written approval.&#xD;
Except as specifically set forth herein, neither party shall use the other party's name or trademark, or the name nor trademark of such other party's affiliate, in any publicity, advertising or announcement, or disclose the existence or terms of this Agreement, without the consenting party's prior written approval.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Latania Chura</name_or_title>
      <organization>Abbott Vascular</organization>
      <phone>503-935-3002</phone>
      <email>latania.chura@abbott.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02229864
org study id: 10-392 B
nct id: NCT02229864
lead sponsor: 
has dmc: Yes
The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling
      approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB
      III RCT (NCT01751906). The objective is to determine the pharmacokinetics of everolimus
      delivered by the Absorb BVS in a separate and non-randomized cohort of subjects who only
      receive Absorb BVS with a maximum of two de novo native coronary artery lesions after
      implantation of the Absorb BVS.

      Note: The ABSORB III PK subjects will not contribute to the determination of the ABSORB III
      RCT primary endpoint.
To ensure the PK measurements reflect everolimus exposure due to Absorb BVS only, the PK
      sub-study will not allow non-target lesion treatment.

      Blood Sampling Timing:

        -  Pre-Absorb BVS implantation: Baseline

           o Baseline is defined as prior to implantation of the first Absorb BVS; the blood sample
           will be drawn on the day of the index procedure either through a heparin lock, venous
           sheath, or venipuncture.

        -  Post-Absorb BVS implantation: 10 and 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 24
           hrs (1 day), 48 hrs (2 days), 72 hrs (3 days), 96 hrs (4 days), 120 hrs (5 days), 168
           hrs (7 days), 336 hrs (14 days), and 720 hrs (30 days).

             -  Post-implantation blood samples will be drawn at the time intervals stated above;
                timing of the post-implantation sampling will begin when the last Absorb BVS is
                deployed, i.e. last Absorb BVS delivery catheter is removed from the body.

      Pharmacokinetic (PK) parameters will include time to maximum concentration (tmax); maximum
      concentration (Cmax); AUC24h: Area under the blood analyte concentration vs. time curve from
      time 0 up to 24 hours post placement of the last Absorb BVS; AUClast: Area under the blood
      analyte concentration vs. time curve from time 0 up to the last quantifiable concentration;
      AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and
      extrapolated to infinite time; terminal elimination rate constant (λz); terminal elimination
      half-life (t1/2term); drug clearance (CL).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Concentration (Cmax)
time frame: 0 to 30 days
description: Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
measure: Time of Maximum (Tmax)
time frame: 0 to 30 days
description: Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
measure: AUC24h
time frame: 0 to 24 hours
description: Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.
measure: AUC Last
time frame: 0 to 30 days
description: Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.
measure: AUC 0-infinity
time frame: 0 to 30 days
description: AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
calculated as: AUC0-∞ = AUClast + (Clast/λz)
The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as:
%AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ * 100
measure: Terminal Elimination Rate Constant (λz)
time frame: 0 to 30 days
description: The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.
measure: Terminal Elimination Half-life (t1/2term)
time frame: 0 to 30 days
description: The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
calculated as: t1/2term = 0.693/λz.
measure: Drug Clearance (CL)
time frame: 0 to 30 days
description: The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
Calculated as: CL = Dose/AUC0 - ∞ .
measure: Number of Participants With Target Lesion Failure (TLF)
time frame: 0 to 1853 Days
description: Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
measure: Number of Participants With All Death
time frame: 0 to 1853 Days
description: All death includes cardiac death, vascular death, and non-cardiac death.
measure: Number of Participants With All Myocardial Infarction (MI)
time frame: 0 to 1853 Days
description: All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
measure: Number of Participants With All Target Lesion Revascularization (TLR)
time frame: 0 to 1853 Days
description: All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
measure: Number of Participants With All Target Vessel Revascularization (TVR)
time frame: 0 to 1853 Days
description: All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
measure: Number of Participants With All Revascularization
time frame: 0 to 1853 Days
description: All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
measure: Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable)
time frame: ≤ 1 day
description: Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
measure: Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable)
time frame: >1 to 30 days
description: Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
measure: Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable)
time frame: 31 to 393 days
description: Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
measure: Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)
time frame: 0 to 1853 Days
description: Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
arm group label: Coronary artery stenting: Absorb BVS
arm group type: Experimental
description: Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
intervention type: Device
intervention name: Coronary artery stenting: Absorb BVS
description: Scaffold diameters: 2.5, 3.0 and 3.5 mm
Scaffold lengths: 8, 12, 18, and 28 mm
arm group label: Coronary artery stenting: Absorb BVS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David G. Rizik, MD
role: Principal Investigator
affiliation: Scottsdale Healthcare, Scottsdale, AZ
last name: Louis A. Cannon, MD
role: Principal Investigator
affiliation: Cardiac and Vascular Research Center of Northern Michigan Petoskey, MI
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Coronary Stenosis
mesh term: Constriction, Pathologic
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 