<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/NCT03033862</url>
  </required_header>
  <id_info>
    <org_study_id>16-2565</org_study_id>
    <nct_id>NCT03033862</nct_id>
  </id_info>
  <brief_title>Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds</brief_title>
  <official_title>Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inova Health Care Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inova Health Care Services</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Platelet activation and aggregation, intrinsic thrombogenicity, and biomarkers (fibrinogen,&#xD;
      C-reactive protein, platelet endothelial cell adhesion molecule, von Willebrand factor,&#xD;
      p-selectin) will be measured and compared following the implantation of Bioreabsorbable&#xD;
      Vascular Scaffolds and Drug Eluting Stents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Stent taken off market due to safety concerns&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Thrombogenicity from baseline after device implantation</measure>
    <time_frame>60 Days</time_frame>
    <description>Platelet activation and aggregation, intrinsic thrombogenicity, and biomarkers will be measured at baseline and then reassessed at multiple time points after the implantation of the study device.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Intervention with Bioresorbable Vascular Scaffold</arm_group_label>
    <description>Implant of Abbott Bioresorbable stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention with Drug Eluting Stent</arm_group_label>
    <description>implant of drug eluting stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bioresorbable Vascular Scaffold</intervention_name>
    <description>Bioresorbable Vascular Scaffold</description>
    <arm_group_label>Intervention with Bioresorbable Vascular Scaffold</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Drug Eluting Stent</intervention_name>
    <description>Drug Eluting Stent</description>
    <arm_group_label>Intervention with Drug Eluting Stent</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include subjects with stable ischemic heart disease receiving percutaneous&#xD;
        coronary intervention.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject may be of either sex and of any race, and must be &gt;18 years of age.&#xD;
&#xD;
          2. Subjects undergoing elective PCI due to de novo native coronary artery lesions (length&#xD;
             ≤24 mm) with a reference vessel diameter of ≥2.5 mm and ≤3.75 mm.&#xD;
&#xD;
          3. Subject agrees to not participate in any other investigational or invasive clinical&#xD;
             study for a period of 3 months following the index procedure.&#xD;
&#xD;
          4. Subject must be willing and able to give appropriate informed consent.&#xD;
&#xD;
          5. The subject is able to read and has signed and dated the informed consent document&#xD;
             including authorization permitting release of personal health information approved by&#xD;
             the investigator's Institutional Review Board (IRB).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemodynamically unstable at the time of enrollment.&#xD;
&#xD;
          -  Concurrent or anticipated treatment with warfarin (or derivatives, e.g.,&#xD;
             phenprocoumon), oral factor Xa inhibitor, or oral direct thrombin inhibitor after&#xD;
             enrollment.&#xD;
&#xD;
          -  GPI use prior to or at the time of PCI.&#xD;
&#xD;
          -  History of a bleeding, or evidence of active abnormal bleeding.&#xD;
&#xD;
          -  History at any time of intracranial hemorrhage, intracranial or spinal cord surgery,&#xD;
             or a central nervous system tumor or aneurysm.&#xD;
&#xD;
          -  Documented sustained severe hypertension (systolic blood pressure &gt;200 mmHg or&#xD;
             diastolic blood pressure &gt;110 mmHg) at enrollment.&#xD;
&#xD;
          -  Severe valvular heart disease, as defined by the American College of Cardiology&#xD;
             /American Heart Association.&#xD;
&#xD;
          -  History within 30 days before enrollment of invasive surgeries (other than mentioned&#xD;
             above), or is anticipating one during the course of their study participation, or is&#xD;
             planning to have one within 1 month post dosing with the study drug.&#xD;
&#xD;
          -  History within 30 days before enrollment of TIA and ischemic (presumed thrombotic)&#xD;
             stroke/CVA.&#xD;
&#xD;
          -  Known platelet count &lt;100,000/mm3 within 30 days before enrollment.&#xD;
&#xD;
          -  Known active hepatobiliary disease, or known unexplained persistent increase in serum&#xD;
             alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity to two&#xD;
             times or more the upper limit of the reference range (upper limit of &quot;normal&quot;&#xD;
             [↑2xULN]).&#xD;
&#xD;
          -  Any serious medical comorbidity (e.g., active malignancy) such that the subject's life&#xD;
             expectancy is &lt;24 months.&#xD;
&#xD;
          -  Known current substance abuse at the time of enrollment.&#xD;
&#xD;
          -  Current participation in any other study of investigational therapy or participation&#xD;
             in such a study within the last 30 days.&#xD;
&#xD;
          -  Known hypersensitivity to any component of the current investigational product.&#xD;
&#xD;
          -  Female subject of child-bearing potential.&#xD;
&#xD;
          -  Subject is a woman who is breast-feeding.&#xD;
&#xD;
          -  Subject is part of the staff personnel directly involved with this study or is a&#xD;
             family member of the investigational staff.&#xD;
&#xD;
          -  LVEF &lt;30%&#xD;
&#xD;
          -  Subject with known renal insufficiency with an estimated GFR &lt;30 ml/min/1.73m or&#xD;
             dialysis at the time of screening&#xD;
&#xD;
          -  Subject requiring at least two lesion treatment and more suitable for staged PCI.&#xD;
&#xD;
          -  Moderate or heavy calcification, tortuosity or other conditions are present proximal&#xD;
             or within the target segment, reducing the likelihood that the Absorb BVS or XIENCE&#xD;
             can be either delivered to or expanded at the lesion.&#xD;
&#xD;
          -  Extreme angulation (≥90°) proximal to or within the target lesion.&#xD;
&#xD;
          -  Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.&#xD;
&#xD;
          -  Lesion located within or distal to a diseased arterial graft or SVG.&#xD;
&#xD;
          -  Aorto-ostial lesion (within 3 mm of the aorta junction).&#xD;
&#xD;
          -  Lesion located in the left main artery.&#xD;
&#xD;
          -  Lesion located within 2 mm of the origin of the LAD or LCX.&#xD;
&#xD;
          -  Lesion involving a bifurcation with a:&#xD;
&#xD;
               -  side branch ≥ 2 mm in diameter, or&#xD;
&#xD;
               -  side branch with either an ostial or non-ostial lesion with diameter stenosis &gt;&#xD;
                  50%, or&#xD;
&#xD;
               -  side branch requiring dilatation.&#xD;
&#xD;
          -  Target vessel contains thrombus.&#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>Paul A Gurbel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inova Health Care Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03033862
org study id: 16-2565
nct id: NCT03033862
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Platelet activation and aggregation, intrinsic thrombogenicity, and biomarkers (fibrinogen,
      C-reactive protein, platelet endothelial cell adhesion molecule, von Willebrand factor,
      p-selectin) will be measured and compared following the implantation of Bioreabsorbable
      Vascular Scaffolds and Drug Eluting Stents.
observational model: Cohort
time perspective: Prospective
measure: Change in Thrombogenicity from baseline after device implantation
time frame: 60 Days
description: Platelet activation and aggregation, intrinsic thrombogenicity, and biomarkers will be measured at baseline and then reassessed at multiple time points after the implantation of the study device.
arm group label: Intervention with Bioresorbable Vascular Scaffold
description: Implant of Abbott Bioresorbable stent
arm group label: Intervention with Drug Eluting Stent
description: implant of drug eluting stent
intervention type: Device
intervention name: Bioresorbable Vascular Scaffold
description: Bioresorbable Vascular Scaffold
arm group label: Intervention with Bioresorbable Vascular Scaffold
intervention type: Device
intervention name: Drug Eluting Stent
description: Drug Eluting Stent
arm group label: Intervention with Drug Eluting Stent
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul A Gurbel, MD
role: Principal Investigator
affiliation: Inova Health Care Services
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease