<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/NCT01673373</url>
  </required_header>
  <id_info>
    <org_study_id>iCAST™ RX-ARAS-001</org_study_id>
    <nct_id>NCT01673373</nct_id>
  </id_info>
  <brief_title>Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension</brief_title>
  <acronym>ARTISAN</acronym>
  <official_title>ARTISAN: iCAST™ RX De Novo Stent Placement for the Treatment of Atherosclerotic Renal Artery Stenosis in Patients With Resistant Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Atrium Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Atrium Medical Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to test how well the iCAST™ RX Stent works in patients diagnosed&#xD;
      with atherosclerotic renal artery stenosis and whether or not increased blood flow by the&#xD;
      stent will help to control blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-arm, multicenter clinical trial that will take place at up to&#xD;
      25 US/ Outside US (OUS) sites. Primary endpoints have been determined to show the safety,&#xD;
      effectiveness, and clinical outcomes of the iCAST™ RX Stent System. Safety and effectiveness&#xD;
      will be evaluated based on the primary patency rate at 9-months on a per lesion basis&#xD;
      evaluated against a performance goal of published studies with bare-metal stents. The primary&#xD;
      clinical endpoint will assess the improvement in Systolic Blood Pressure (SBP) at 9-months as&#xD;
      compared to baseline Systolic Blood Pressure.&#xD;
&#xD;
      Eligible subjects will undergo a two-week Medical Documentation Screening period to confirm&#xD;
      resistant hypertension (SBP ≥ 155mmHg) while on maximum tolerable doses of ≥ three&#xD;
      anti-hypertensive medications from at least three distinct classes of drugs, one of which&#xD;
      must be a diuretic.&#xD;
&#xD;
      There must be documented clinical evidence to support likelihood of angiographic findings &gt;&#xD;
      80% whether it is Duplex Ultrasound (DUS), Computed Tomography angiogram (CTa), Magnetic&#xD;
      Resonance angiogram (MRa) or other medical evidence. After meeting screening and clinical&#xD;
      eligibility criteria, subjects will undergo a baseline assessment for angiographic&#xD;
      eligibility. After angiographic documentation of a ≥ 80% renal artery stenosis or Fraction&#xD;
      Flow Reserve (FFR) &lt; 0.8 is confirmed, the subject may be enrolled in the trial by placement&#xD;
      of the investigational device.&#xD;
&#xD;
      The 9-month visit will include a follow-up DUS of the target renal artery. If the DUS is&#xD;
      non-diagnostic due to an imaging problem, such as overlying bowel gas or body habitus, a&#xD;
      second DUS may be attempted. If the DUS is indicative of ≥ 60% stenosis as determined by the&#xD;
      core laboratory, or the second DUS remains non-diagnostic, a contrast angiogram will be used&#xD;
      to assess the degree of restenosis of the covered stent(s).&#xD;
&#xD;
      Clinical follow-up visits will be required for all enrolled subjects at 30-days, 9-months,&#xD;
      12-months, 24-months, and 36-months. A 6-month and 18-month visit will occur via telephone to&#xD;
      collect medication usage and Adverse Events (AEs) only. The 36-month clinic office visit will&#xD;
      be required as the final safety visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2012</start_date>
  <completion_date type="Actual">October 26, 2020</completion_date>
  <primary_completion_date type="Actual">June 27, 2018</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>Primary Patency</measure>
    <time_frame>9 months</time_frame>
    <description>Primary patency rate at 9 months was defined as continuous patency without the occurrence of a total occlusion of the original lesion, without a re-intervention to treat a partial or total occlusion of the stented segment, or bypass of the stented segment due to clinically-driven restenosis or occlusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Baseline and 9 months</time_frame>
    <description>Change in systolic blood pressure (SBP) at 9 months as compared to baseline SBP.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure-Related Major Adverse Events (MAE)</measure>
    <time_frame>30 days, 9 months</time_frame>
    <description>The occurence of procedure-related MAEs is reported as a percentage of subjects with MAE. Inclusive of:&#xD;
Procedure- or device-related occurrence of death&#xD;
Q-Wave myocardial infarction (MI)&#xD;
Clinically driven target lesion revascularization (TLR)&#xD;
Significant embolic events defined as unanticipated kidney/bowel infarct, clinically driven by symptoms of abdominal or back pain and confirmed with CT scan or open surgery; lower extremity ulceration or gangrene; or kidney failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Success</measure>
    <time_frame>Day of Procedure</time_frame>
    <description>Technical success is defined as successful delivery and deployment of the iCAST™ RX Stent System with ≤ 30% residual angiographic stenosis after covered stent deployment (including post-dilatation) assessed via quantitative vascular analysis (QVA) by an independent core laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Procedural Success</measure>
    <time_frame>Day of Procedure, prior to hospital discharge</time_frame>
    <description>Acute procedural success is defined as technical success without the occurrence of MAE prior to hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Revascularization (TLR)</measure>
    <time_frame>9 months</time_frame>
    <description>Target Lesion Revascularization (TLR) is measured as the proportion of subjects-lesions that require a clinically-driven reintervention of the target lesion through 9 months.&#xD;
a. A clinically-driven TLR is defined as a TLR (percutaneous balloon angioplasty (PTA), bare metal stent or repeat covered stent deployment, or surgical bypass) due to documented recurrent hypertension from 30-days post-procedure level and/or deterioration in renal function from baseline value, associated with angiographic core laboratory adjudication of a ≥ 60% diameter covered stent restenosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Incidental TLR</measure>
    <time_frame>9 months</time_frame>
    <description>The rate of incidental TLR is the rate of TLRs not meeting the definition of a clinically-driven TLR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure (SBP) Control</measure>
    <time_frame>Baseline and 30 days</time_frame>
    <description>The change in SBP from baseline to 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SBP Control</measure>
    <time_frame>Baseline and 9 months</time_frame>
    <description>The change in SBP from baseline to 9 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Patency Rate</measure>
    <time_frame>9 months</time_frame>
    <description>Secondary patency rate at 9 months after a clinically-driven TLR which restores patency after total occlusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Anti-Hypertensive Medications</measure>
    <time_frame>Baseline and 9 months</time_frame>
    <description>Change in number of anti-hypertensive medications as compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Renal Function</measure>
    <time_frame>Baseline and 30 days</time_frame>
    <description>Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Renal Function</measure>
    <time_frame>Baseline and 9 months</time_frame>
    <description>Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 9 months.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Renal Artery Stenosis</condition>
  <condition>Hypertension, Renovascular</condition>
  <arm_group>
    <arm_group_label>iCAST RX™ Stent Systen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All enrolled subjects will receive the iCAST RX™ Stent System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iCAST™ Rx Stent System</intervention_name>
    <description>All enrolled subjects will undergo primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
    <arm_group_label>iCAST RX™ Stent Systen</arm_group_label>
    <other_name>iCAST™ RX</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 at the time of informed consent.&#xD;
&#xD;
          2. Subject or subject's legal representative have been informed of the nature of the&#xD;
             trial, agrees to participate, and has signed an Institutional Review Board&#xD;
             (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF).&#xD;
&#xD;
          3. Subjects that have bilateral kidneys or a solitary functioning kidney with Renal&#xD;
             Artery Stenosis in at least one kidney and an average Systolic Blood Pressure (SBP) ≥&#xD;
             155mmHg.&#xD;
&#xD;
          4. Subject has a history of maximum tolerable dose of ≥ 3 anti-hypertensive medications&#xD;
             of different classes, one of which must be a diuretic (for at least two weeks prior to&#xD;
             Medical Documentation Screening period).&#xD;
&#xD;
             a. A documented history for a minimum of 3 months showing reasonable and aggressive&#xD;
             efforts to manage hypertension prior to consent. This must include the use of a broad&#xD;
             variety of medications that have been used and failed or not tolerated.&#xD;
&#xD;
          5. Subject must have documented clinical evidence to support likelihood of angiographic&#xD;
             findings &gt; 80% whether it is DUS, CTa, MRa or other medical evidence.&#xD;
&#xD;
          6. New York Heart Association (NYHA) class I, II, or III the time of trial enrollment.&#xD;
&#xD;
        Note: When a subject has bilateral Renal Artery Stenosis both of which require stenting, it&#xD;
        is recommended to treat both kidneys with an iCAST™ RX Stent System during the index&#xD;
        procedure. In the event that a subject needs a renal stenting procedure staged for renal&#xD;
        protection, it is important that the Investigator treats the second renal artery with an&#xD;
        iCAST™ RX Stent System after 30 days of the index procedure. If subjects with bilateral&#xD;
        stenosis have only one lesion that meets protocol inclusion criteria that lesion should be&#xD;
        treated per protocol. The recommendation is to NOT treat the second non-qualifying lesion,&#xD;
        however if the operator feels strongly it is indicated, then they should treat per standard&#xD;
        of care after 30-days post index procedure in order to comply with exclusion criteria #10.&#xD;
&#xD;
        Subjects with flash pulmonary edema are allowed into the trial should they meet all other&#xD;
        Inclusion and Exclusion criteria.&#xD;
&#xD;
        Angiographic Anatomic Inclusion Criteria:&#xD;
&#xD;
          1. Angiographic diameter renal artery stenosis ≥ 80% involving unilateral or bilateral&#xD;
             renal arteries.&#xD;
&#xD;
             a. The degree of percent diameter stenosis for all lesions intended to be treated,&#xD;
             must be confirmed via one of the following methods: i. Manual or automated measurement&#xD;
             with calipers ii. Measured Flow Fraction Reserve (FFR) &lt; 0.8 using a pressure wire&#xD;
             iii. Measured translesional peak pressure gradient of &gt; 21 mmHg after induced&#xD;
             hyperemia via dopamine or papaverine using a 4 Fr or less catheter or pressure wire.&#xD;
&#xD;
             b. Subjects with 60-79% angiographic stenosis who have confirmed FFR &lt; 0.8 may be&#xD;
             enrolled.&#xD;
&#xD;
          2. Renal pole-to-pole length &gt; 8cm (per visual estimate).&#xD;
&#xD;
          3. Target lesion length ≤ 16mm per vessel (per visual estimate).&#xD;
&#xD;
          4. Renal artery vessel diameter ≥ 5.0mm and ≤ 7.0mm (per visual estimate).&#xD;
&#xD;
          5. Lesion originating ≤ 15mm of the renal ostium.&#xD;
&#xD;
        General Exclusion Criteria:&#xD;
&#xD;
          1. Subject's estimated life expectancy is &lt; 12 months.&#xD;
&#xD;
          2. Subject has a history of transplanted kidney(s), has had another recent organ&#xD;
             transplant or polycystic kidney disease.&#xD;
&#xD;
          3. Subject with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2&#xD;
&#xD;
          4. Subject has a history of bleeding diathesis or coagulopathy or refuses blood&#xD;
             transfusions.&#xD;
&#xD;
          5. Subject has a known contraindication to heparin, aspirin, thienopyridine, other&#xD;
             anti-coagulant/antithrombotic therapies, contrast media, stainless steel, and/or&#xD;
             polytetrafluoroethylene (PTFE).&#xD;
&#xD;
          6. Subject has had a previous renal bypass operation, a bypass is planned, or the target&#xD;
             lesion is located within or beyond a bypass graft.&#xD;
&#xD;
          7. Subject has received a thrombolytic agent within the past 30 days.&#xD;
&#xD;
          8. Subject has documented acute pulmonary edema or systolic heart failure with ejection&#xD;
             fraction &lt; 30% and/or hospitalization requiring intubation and ventilation support for&#xD;
             this diagnosis within the previous 90 days or hypertensive emergencies defined as&#xD;
             resulting in organ damage.&#xD;
&#xD;
          9. Concurrent enrollment in any investigational trial wherein subject's participation has&#xD;
             not been completed.&#xD;
&#xD;
         10. Subject has had a planned or anticipated cardiovascular surgical or interventional&#xD;
             procedure outside of the affected renal artery (including, but not limited to, aortic,&#xD;
             renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30 days prior to&#xD;
             the index procedure and prior to completion of the 30 day follow-up.&#xD;
&#xD;
         11. Subject has suffered a stroke or Transient Ischemic Attack (TIA) in the past 3 months.&#xD;
&#xD;
         12. Subject is pregnant, lactating, or is of child-bearing potential and plans to become&#xD;
             pregnant during the follow-up trial period.&#xD;
&#xD;
         13. Subject with significant valvular disease.&#xD;
&#xD;
         14. Subject with known significant proteinuria &gt; 2+ or &gt; 2.0gm/d.&#xD;
&#xD;
         15. Subject with known bilateral upper-extremity arterial stenosis that result in&#xD;
             spuriously low arm pressures or without the ability to gain reliable blood pressure&#xD;
             measurements in at least one upper extremity.&#xD;
&#xD;
         16. Subject with active sepsis.&#xD;
&#xD;
         17. Subject with serum creatinine ≥ 3.0mg/dL.&#xD;
&#xD;
         18. Subject with NYHA Class IV at the time of enrollment.&#xD;
&#xD;
         19. Subject is on hemodialysis.&#xD;
&#xD;
         20. Subject has a history of renal aneurysm.&#xD;
&#xD;
         21. Subject with cardiogenic shock.&#xD;
&#xD;
         22. Subject with cardiomyopathy.&#xD;
&#xD;
         23. Subject has an uncontrolled concurrent illness, including but not limited to ongoing&#xD;
             or active infection or active autoimmune disease requiring immunosuppressive therapy.&#xD;
&#xD;
         24. Any subject with clinically significant cardiovascular, respiratory, neurologic,&#xD;
             hepatic, endocrine, major systematic disease, making implementation or interpretation&#xD;
             of the protocol or protocol results difficult or who in the opinion of the&#xD;
             investigator would not be a good candidate for enrollment.&#xD;
&#xD;
        Angiographic Anatomic Exclusion Criteria:&#xD;
&#xD;
          1. The planned site of intervention is totally occluded or has an anatomic configuration&#xD;
             likely to prohibit adequate dilatation, and/or passage or implantation of the&#xD;
             investigational device.&#xD;
&#xD;
          2. Subject has multiple ipsilateral lesions of the target renal artery that cannot be&#xD;
             covered by a single stent.&#xD;
&#xD;
          3. There is a previously implanted stent in the target vessel or there is a previously&#xD;
             implanted stent in the contralateral vessel &lt; one year.&#xD;
&#xD;
          4. Subject has fibromuscular dysplasia, in renal artery and/or other vascular bed.&#xD;
&#xD;
          5. The target lesion site is associated with a thrombus.&#xD;
&#xD;
          6. Target lesion treated with laser atherectomy, directional atherectomy or other&#xD;
             adjuncts to percutaneous balloon angioplasty (PTA).&#xD;
&#xD;
          7. Subject has a critical stenotic (&gt; 70%) small accessory renal artery.&#xD;
&#xD;
          8. Subject has an abdominal aortic aneurysm &gt; 4.0cm in diameter or a severe&#xD;
             atherosclerotic aorta.&#xD;
&#xD;
          9. Main renal artery length ≤ 15mm precluding the safe deployment of a covered renal&#xD;
             stent.&#xD;
&#xD;
         10. Any lesion that would include blocking of renal artery side branch.&#xD;
&#xD;
         11. Renal artery stenosis due to dissection of renal artery: spontaneous or traumatic.&#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>Ken Rosenfield, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gary Ansel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OhioHealth Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mission Cardiovascular Research Institute</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of the Rockies</name>
      <address>
        <city>Loveland</city>
        <state>Colorado</state>
        <zip>80538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clearwater Cardiovascular and Interventional Consultants</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Health and Hospitals Corporation</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Health Systems</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Name Medical Center</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Carolina Cardiology</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NC Heart and Vascular Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OhioHealth Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellmont CVA Heart Institute</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennova Healthcare - Turkey Creek Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37934</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>June 27, 2019</results_first_submitted>
  <results_first_submitted_qc>July 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 13, 2019</results_first_posted>
  <last_update_submitted>November 5, 2020</last_update_submitted>
  <last_update_submitted_qc>November 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal Artery Stenosis</keyword>
  <keyword>Renal Artery Obstruction</keyword>
  <keyword>Renovascular Hypertension</keyword>
  <keyword>Resistant Hypertension</keyword>
  <keyword>Renal Revascularization</keyword>
  <keyword>Atherosclerotic Renal Artery Stenosis</keyword>
  <keyword>Atherosclerotic Renal Artery Stenosis (ARAS)</keyword>
  <keyword>Renal Artery Stenosis (RAS)</keyword>
  <keyword>Uncontrolled hypertension</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Systolic blood pressure</keyword>
  <keyword>Blood pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Artery Obstruction</mesh_term>
    <mesh_term>Hypertension, Renovascular</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 15, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT01673373/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT01673373/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>iCAST™ RX Stent System</title>
          <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66">Completed primary endpoint follow up.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </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_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>iCAST™ RX Stent System</title>
          <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="68"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="71.7" spread="10.17"/>
                  </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="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Qualifying Lesions</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Unilateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="166.2" spread="12.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Patency</title>
        <description>Primary patency rate at 9 months was defined as continuous patency without the occurrence of a total occlusion of the original lesion, without a re-intervention to treat a partial or total occlusion of the stented segment, or bypass of the stented segment due to clinically-driven restenosis or occlusion.</description>
        <time_frame>9 months</time_frame>
        <population>Subset of enrolled subjects with available duplex ultrasound or angiography assessment within the 9-month visit window.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Patency</title>
          <description>Primary patency rate at 9 months was defined as continuous patency without the occurrence of a total occlusion of the original lesion, without a re-intervention to treat a partial or total occlusion of the stented segment, or bypass of the stented segment due to clinically-driven restenosis or occlusion.</description>
          <population>Subset of enrolled subjects with available duplex ultrasound or angiography assessment within the 9-month visit window.</population>
          <units>Subject-lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Subject-lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Subject-lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The original Performance Goal of 70% patency rate was derived from a thorough literature review of trials with renal bare metal stent placement. Other assumptions included a determination of samples size based upon a one-sided alpha of 0.025 and desired power of 87%, and assumption of 10% attrition. The null hypothesis was that the incidence of primary patency at 9 months is less than or equal to 70%.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Due to the early termination of enrollment, all inferential analyses were interpreted as descriptive and carried out in an exploratory manner.</non_inferiority_desc>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>The p-value was computed using a one-sided exact test of the difference between the observed rate and the Performance Goal (equal to 70%). The defined threshold for statistical significance is .025.</p_value_desc>
            <method>one-sided exact</method>
            <other_analysis_desc>The cumulative incidence of primary patency was computed as the number of subject-lesions with primary patency at 9 months divided by the number of subject-lesions and was analyzed using the allowable window of 243 to 303 trial days.&#xD;
An exact binomial one-sided 95% CI was constructed and the lower limit compared to the Performance Goal equal to 70%.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic Blood Pressure</title>
        <description>Change in systolic blood pressure (SBP) at 9 months as compared to baseline SBP.</description>
        <time_frame>Baseline and 9 months</time_frame>
        <population>Subset of enrolled subjects with available blood pressure data at baseline and 9 months.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure</title>
          <description>Change in systolic blood pressure (SBP) at 9 months as compared to baseline SBP.</description>
          <population>Subset of enrolled subjects with available blood pressure data at baseline and 9 months.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7" spread="21.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The primary endpoint of systolic blood pressure was analyzed according to the Performance Goal of a decrease in systolic blood pressure of 10 mmHg between procedure and 9 months.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A one-sided 95% Confidence Interval for the mean difference between baseline and 9-month systolic blood pressure was constructed and the lower limit compared to the 10 mmHg performance goal. A p-value of the difference between the estimated systolic blood pressure change from the baseline and the performance goal was computed using a paired t-test.</non_inferiority_desc>
            <p_value>.0192</p_value>
            <p_value_desc>The defined threshold for statistical significance is .025.</p_value_desc>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure-Related Major Adverse Events (MAE)</title>
        <description>The occurence of procedure-related MAEs is reported as a percentage of subjects with MAE. Inclusive of:&#xD;
Procedure- or device-related occurrence of death&#xD;
Q-Wave myocardial infarction (MI)&#xD;
Clinically driven target lesion revascularization (TLR)&#xD;
Significant embolic events defined as unanticipated kidney/bowel infarct, clinically driven by symptoms of abdominal or back pain and confirmed with CT scan or open surgery; lower extremity ulceration or gangrene; or kidney failure.</description>
        <time_frame>30 days, 9 months</time_frame>
        <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure-Related Major Adverse Events (MAE)</title>
          <description>The occurence of procedure-related MAEs is reported as a percentage of subjects with MAE. Inclusive of:&#xD;
Procedure- or device-related occurrence of death&#xD;
Q-Wave myocardial infarction (MI)&#xD;
Clinically driven target lesion revascularization (TLR)&#xD;
Significant embolic events defined as unanticipated kidney/bowel infarct, clinically driven by symptoms of abdominal or back pain and confirmed with CT scan or open surgery; lower extremity ulceration or gangrene; or kidney failure.</description>
          <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall subjects experiencing MAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MAE within 30 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MAE within 9 months</title>
              <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>Technical Success</title>
        <description>Technical success is defined as successful delivery and deployment of the iCAST™ RX Stent System with ≤ 30% residual angiographic stenosis after covered stent deployment (including post-dilatation) assessed via quantitative vascular analysis (QVA) by an independent core laboratory.</description>
        <time_frame>Day of Procedure</time_frame>
        <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion with available angiography.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Technical Success</title>
          <description>Technical success is defined as successful delivery and deployment of the iCAST™ RX Stent System with ≤ 30% residual angiographic stenosis after covered stent deployment (including post-dilatation) assessed via quantitative vascular analysis (QVA) by an independent core laboratory.</description>
          <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion with available angiography.</population>
          <units>Subject-lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Subject-lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Subject-lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acute Procedural Success</title>
        <description>Acute procedural success is defined as technical success without the occurrence of MAE prior to hospital discharge.</description>
        <time_frame>Day of Procedure, prior to hospital discharge</time_frame>
        <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion with available angiography.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Procedural Success</title>
          <description>Acute procedural success is defined as technical success without the occurrence of MAE prior to hospital discharge.</description>
          <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion with available angiography.</population>
          <units>Subject-lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Subject-lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Subject-lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Revascularization (TLR)</title>
        <description>Target Lesion Revascularization (TLR) is measured as the proportion of subjects-lesions that require a clinically-driven reintervention of the target lesion through 9 months.&#xD;
a. A clinically-driven TLR is defined as a TLR (percutaneous balloon angioplasty (PTA), bare metal stent or repeat covered stent deployment, or surgical bypass) due to documented recurrent hypertension from 30-days post-procedure level and/or deterioration in renal function from baseline value, associated with angiographic core laboratory adjudication of a ≥ 60% diameter covered stent restenosis.</description>
        <time_frame>9 months</time_frame>
        <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Target Lesion Revascularization (TLR)</title>
          <description>Target Lesion Revascularization (TLR) is measured as the proportion of subjects-lesions that require a clinically-driven reintervention of the target lesion through 9 months.&#xD;
a. A clinically-driven TLR is defined as a TLR (percutaneous balloon angioplasty (PTA), bare metal stent or repeat covered stent deployment, or surgical bypass) due to documented recurrent hypertension from 30-days post-procedure level and/or deterioration in renal function from baseline value, associated with angiographic core laboratory adjudication of a ≥ 60% diameter covered stent restenosis.</description>
          <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.</population>
          <units>Subject-lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Subject-lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Subject-lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
              </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>Rate of Incidental TLR</title>
        <description>The rate of incidental TLR is the rate of TLRs not meeting the definition of a clinically-driven TLR.</description>
        <time_frame>9 months</time_frame>
        <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Incidental TLR</title>
          <description>The rate of incidental TLR is the rate of TLRs not meeting the definition of a clinically-driven TLR.</description>
          <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.</population>
          <units>Subject-lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Subject-lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Subject-lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
              </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>Systolic Blood Pressure (SBP) Control</title>
        <description>The change in SBP from baseline to 30 days</description>
        <time_frame>Baseline and 30 days</time_frame>
        <population>Subset of enrolled subjects with available blood pressure measurements at both time points.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure (SBP) Control</title>
          <description>The change in SBP from baseline to 30 days</description>
          <population>Subset of enrolled subjects with available blood pressure measurements at both time points.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.6" spread="18.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SBP Control</title>
        <description>The change in SBP from baseline to 9 months</description>
        <time_frame>Baseline and 9 months</time_frame>
        <population>Subset of enrolled subjects with available blood pressure measurements at both time points.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>SBP Control</title>
          <description>The change in SBP from baseline to 9 months</description>
          <population>Subset of enrolled subjects with available blood pressure measurements at both time points.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.7" spread="21.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Patency Rate</title>
        <description>Secondary patency rate at 9 months after a clinically-driven TLR which restores patency after total occlusion.</description>
        <time_frame>9 months</time_frame>
        <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Patency Rate</title>
          <description>Secondary patency rate at 9 months after a clinically-driven TLR which restores patency after total occlusion.</description>
          <population>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.</population>
          <units>Subject-lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Subject-lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Subject-lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
              </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>Change in Number of Anti-Hypertensive Medications</title>
        <description>Change in number of anti-hypertensive medications as compared to baseline.</description>
        <time_frame>Baseline and 9 months</time_frame>
        <population>Subset of enrolled subjects with available medication information.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Number of Anti-Hypertensive Medications</title>
          <description>Change in number of anti-hypertensive medications as compared to baseline.</description>
          <population>Subset of enrolled subjects with available medication information.</population>
          <units>Number of Anti-hypertensive Medications</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Renal Function</title>
        <description>Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30 days.</description>
        <time_frame>Baseline and 30 days</time_frame>
        <population>Subset of enrolled subjects with available eGFR measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Renal Function</title>
          <description>Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30 days.</description>
          <population>Subset of enrolled subjects with available eGFR measurements.</population>
          <units>eGFR mL/min/1.73 m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5520" spread="8.42795"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Renal Function</title>
        <description>Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 9 months.</description>
        <time_frame>Baseline and 9 months</time_frame>
        <population>Subset of enrolled subjects with available eGFR measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>iCAST™ RX Stent System</title>
            <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Renal Function</title>
          <description>Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 9 months.</description>
          <population>Subset of enrolled subjects with available eGFR measurements.</population>
          <units>eGFR mL/min/1.73 m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9964" spread="13.42781"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years.</time_frame>
      <desc>Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>iCAST™ RX Stent System</title>
          <description>All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Non-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="4" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Normochromic normocytic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Gastrointestinal necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Mesenteric artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Oesophageal spasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arterial restenosis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Skin cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Glomerulonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Brachiocephalic artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Iliac artery stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Intermittent claudication</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Malignant hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Subclavian artery aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Non-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="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Subcutaneous haematoma</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="68"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The limitation of the study was the termination of enrollment due to the change in clinical practice.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Sr. Clinical Trial Manager</name_or_title>
      <organization>Getinge</organization>
      <phone>603-864-5219</phone>
      <email>inka.vesela@getinge.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/NCT01673373
org study id: iCAST™ RX-ARAS-001
nct id: NCT01673373
lead sponsor: 
has dmc: Yes
The purpose of this trial is to test how well the iCAST™ RX Stent works in patients diagnosed
      with atherosclerotic renal artery stenosis and whether or not increased blood flow by the
      stent will help to control blood pressure.
This is a prospective, single-arm, multicenter clinical trial that will take place at up to
      25 US/ Outside US (OUS) sites. Primary endpoints have been determined to show the safety,
      effectiveness, and clinical outcomes of the iCAST™ RX Stent System. Safety and effectiveness
      will be evaluated based on the primary patency rate at 9-months on a per lesion basis
      evaluated against a performance goal of published studies with bare-metal stents. The primary
      clinical endpoint will assess the improvement in Systolic Blood Pressure (SBP) at 9-months as
      compared to baseline Systolic Blood Pressure.

      Eligible subjects will undergo a two-week Medical Documentation Screening period to confirm
      resistant hypertension (SBP ≥ 155mmHg) while on maximum tolerable doses of ≥ three
      anti-hypertensive medications from at least three distinct classes of drugs, one of which
      must be a diuretic.

      There must be documented clinical evidence to support likelihood of angiographic findings >
      80% whether it is Duplex Ultrasound (DUS), Computed Tomography angiogram (CTa), Magnetic
      Resonance angiogram (MRa) or other medical evidence. After meeting screening and clinical
      eligibility criteria, subjects will undergo a baseline assessment for angiographic
      eligibility. After angiographic documentation of a ≥ 80% renal artery stenosis or Fraction
      Flow Reserve (FFR) < 0.8 is confirmed, the subject may be enrolled in the trial by placement
      of the investigational device.

      The 9-month visit will include a follow-up DUS of the target renal artery. If the DUS is
      non-diagnostic due to an imaging problem, such as overlying bowel gas or body habitus, a
      second DUS may be attempted. If the DUS is indicative of ≥ 60% stenosis as determined by the
      core laboratory, or the second DUS remains non-diagnostic, a contrast angiogram will be used
      to assess the degree of restenosis of the covered stent(s).

      Clinical follow-up visits will be required for all enrolled subjects at 30-days, 9-months,
      12-months, 24-months, and 36-months. A 6-month and 18-month visit will occur via telephone to
      collect medication usage and Adverse Events (AEs) only. The 36-month clinic office visit will
      be required as the final safety visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Patency
time frame: 9 months
description: Primary patency rate at 9 months was defined as continuous patency without the occurrence of a total occlusion of the original lesion, without a re-intervention to treat a partial or total occlusion of the stented segment, or bypass of the stented segment due to clinically-driven restenosis or occlusion.
measure: Systolic Blood Pressure
time frame: Baseline and 9 months
description: Change in systolic blood pressure (SBP) at 9 months as compared to baseline SBP.
measure: Procedure-Related Major Adverse Events (MAE)
time frame: 30 days, 9 months
description: The occurence of procedure-related MAEs is reported as a percentage of subjects with MAE. Inclusive of:
Procedure- or device-related occurrence of death
Q-Wave myocardial infarction (MI)
Clinically driven target lesion revascularization (TLR)
Significant embolic events defined as unanticipated kidney/bowel infarct, clinically driven by symptoms of abdominal or back pain and confirmed with CT scan or open surgery; lower extremity ulceration or gangrene; or kidney failure.
measure: Technical Success
time frame: Day of Procedure
description: Technical success is defined as successful delivery and deployment of the iCAST™ RX Stent System with ≤ 30% residual angiographic stenosis after covered stent deployment (including post-dilatation) assessed via quantitative vascular analysis (QVA) by an independent core laboratory.
measure: Acute Procedural Success
time frame: Day of Procedure, prior to hospital discharge
description: Acute procedural success is defined as technical success without the occurrence of MAE prior to hospital discharge.
measure: Target Lesion Revascularization (TLR)
time frame: 9 months
description: Target Lesion Revascularization (TLR) is measured as the proportion of subjects-lesions that require a clinically-driven reintervention of the target lesion through 9 months.
a. A clinically-driven TLR is defined as a TLR (percutaneous balloon angioplasty (PTA), bare metal stent or repeat covered stent deployment, or surgical bypass) due to documented recurrent hypertension from 30-days post-procedure level and/or deterioration in renal function from baseline value, associated with angiographic core laboratory adjudication of a ≥ 60% diameter covered stent restenosis.
measure: Rate of Incidental TLR
time frame: 9 months
description: The rate of incidental TLR is the rate of TLRs not meeting the definition of a clinically-driven TLR.
measure: Systolic Blood Pressure (SBP) Control
time frame: Baseline and 30 days
description: The change in SBP from baseline to 30 days
measure: SBP Control
time frame: Baseline and 9 months
description: The change in SBP from baseline to 9 months
measure: Secondary Patency Rate
time frame: 9 months
description: Secondary patency rate at 9 months after a clinically-driven TLR which restores patency after total occlusion.
measure: Change in Number of Anti-Hypertensive Medications
time frame: Baseline and 9 months
description: Change in number of anti-hypertensive medications as compared to baseline.
measure: Change in Renal Function
time frame: Baseline and 30 days
description: Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30 days.
measure: Change in Renal Function
time frame: Baseline and 9 months
description: Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 9 months.
arm group label: iCAST RX™ Stent Systen
arm group type: Experimental
description: All enrolled subjects will receive the iCAST RX™ Stent System
intervention type: Device
intervention name: iCAST™ Rx Stent System
description: All enrolled subjects will undergo primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
arm group label: iCAST RX™ Stent Systen
other name: iCAST™ RX
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ken Rosenfield, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Gary Ansel, MD
role: Principal Investigator
affiliation: OhioHealth Research Institute
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country: United States
responsible party type: Sponsor
mesh term: Renal Artery Obstruction
mesh term: Hypertension, Renovascular
mesh term: Hypertension
mesh term: Constriction, Pathologic
sharing ipd: No
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The limitation of the study was the termination of enrollment due to the change in clinical practice.
point of contact: 