<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/NCT01732341</url>
  </required_header>
  <id_info>
    <org_study_id>STENTYS</org_study_id>
    <nct_id>NCT01732341</nct_id>
  </id_info>
  <brief_title>Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction</brief_title>
  <acronym>APPOSITION V</acronym>
  <official_title>APPOSITION V: Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stentys</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stentys</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test compare the Stentys Stent with the Multi-Link Vision™ stent system&#xD;
      (Abbott Vascular Inc.)in patients with a heart attack. It is expected that the Stentys stent&#xD;
      is not worse than the Vision stent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary artery disease continues to be the most common cause of morbidity and mortality in&#xD;
      the occidental world. Treatment of coronary atherosclerotic disease has been significantly&#xD;
      advanced by interventional cardiology, and in particular the advent of coronary arterial&#xD;
      stents. In comparison to angioplasty alone, stents have reduced the incidence of angiographic&#xD;
      as well as clinical restenosis, the recurrence of angina, the need for coronary arterial&#xD;
      bypass graft (CABG) surgery, the need for repeat revascularization and the occurrence of&#xD;
      major adverse cardiac events (MACE).However,problems remain due to failure to achieve optimal&#xD;
      stent apposition and normal myocardial reperfusion. Early stent malapposition may be due to&#xD;
      incomplete expansion or undersizing of balloon-expandable stents. Several studies have&#xD;
      emphasized the importance of early malapposition in the setting of ST elevation MI, in which&#xD;
      substantial thrombotic burden and the presence of diffuse vasoconstriction may be&#xD;
      contributory. The Stentys Coronary Stent System includes a self-expanding bare metal&#xD;
      (nitinol) stent on a rapid exchange (RX) delivery system. In view of the theoretical&#xD;
      implications of malapposition, the self-expanding property may offer a potential benefit.&#xD;
&#xD;
      This study is designed to evaluate the safety and effectiveness of the Stentys Coronary Stent&#xD;
      System in the treatment of de novo stenotic lesions in coronary arteries in patients&#xD;
      undergoing primary revascularization due to AMI as compared to the Multi-Link Vision™&#xD;
      coronary stent system (Abbott Vascular Inc. The study is powered for non-inferiority of the&#xD;
      Stentys Coronary Stent System compared to the Vision Stent System.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Decision to discontinue patient follow-up at 2 years.&#xD;
  </why_stopped>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Target Vessel Failure</measure>
    <time_frame>12 months.</time_frame>
    <description>From date of randomization until the date of first documented TVF, assessed up to 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute Stent Malapposition</measure>
    <time_frame>Immediately after procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">318</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>STENTYS self-apposing stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention to treat STEMI with the STENTYS self-apposing stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VISION balloon-expandable stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>STEMI treatment with a VISION balloon-expandable stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>STENTYS self-apposing stent</intervention_name>
    <description>Intervention to treat STEMI with the STENTYS self-apposing stent</description>
    <arm_group_label>STENTYS self-apposing stent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VISION balloon-expandable stent</intervention_name>
    <description>STEMI treatment with a VISION balloon-expandable stent&#xD;
--------------------------------------------------------------------------------</description>
    <arm_group_label>VISION balloon-expandable stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        General Inclusion Criteria&#xD;
&#xD;
          1. Subject ≥ 18 years old.&#xD;
&#xD;
          2. Subject experiencing clinical symptoms consistent with AMI of &gt;30 min. in duration.&#xD;
&#xD;
          3. ST elevation ≥1 mm in ≥2 contiguous leads or new left bundle branch block, or true&#xD;
             posterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads.&#xD;
&#xD;
          4. Symptom duration is &lt;12 hours prior to signing informed consent.&#xD;
&#xD;
          5. Subject should be in catheterization laboratory and procedure started within 2 hours&#xD;
             of consent.&#xD;
&#xD;
          6. Patient provides written informed consent.&#xD;
&#xD;
          7. Patient agrees to all required follow-up procedures and visits.&#xD;
&#xD;
        Angiographic Inclusion Criteria&#xD;
&#xD;
          1. Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated&#xD;
             use of stenting.&#xD;
&#xD;
          2. The vessel diameter is either known or expected to be 2.5-4.0mm, without excessive&#xD;
             tortuosity or diffuse distal disease.&#xD;
&#xD;
          3. Lesion length ≥12mm and ≤ 23mm&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General Exclusion Criteria&#xD;
&#xD;
          1. Currently enrolled in another investigational device or drug trial that has not&#xD;
             completed the primary endpoint or that clinically interferes with the current study&#xD;
             endpoints.&#xD;
&#xD;
          2. A previous coronary interventional procedure of any kind within 30 days prior to the&#xD;
             procedure.&#xD;
&#xD;
          3. Female patients of childbearing potential known to be pregnant.&#xD;
&#xD;
          4. Patients undergoing cardiopulmonary resuscitation.&#xD;
&#xD;
          5. Cardiogenic shock (SBP &lt;80 mmHg for &gt;30 minutes, or requiring IV pressors or emergency&#xD;
             IABP for hypotension).&#xD;
&#xD;
          6. The subject requires multivessel PCI at time of index procedure or any staged&#xD;
             procedure of the target vessel within 9 months or any non-target vessel within 30 days&#xD;
             post-procedure.&#xD;
&#xD;
          7. The target lesion requires treatment with a device other than PTCA prior to stent&#xD;
             placement (such as, but not limited to, directional coronary atherectomy, excimer&#xD;
             laser, rotational atherectomy, etc.). Thrombus aspiration may be used per operator&#xD;
             discretion.&#xD;
&#xD;
          8. Attempted thrombolysis.&#xD;
&#xD;
          9. Co-morbid condition(s) that could limit the subject's ability to participate in the&#xD;
             trial or to comply with follow-up requirements, or impact the scientific integrity of&#xD;
             the trial.&#xD;
&#xD;
         10. Concurrent medical condition with a life expectancy of less than 12 months.&#xD;
&#xD;
         11. Known left ventricular ejection fraction (LVEF) &lt; 25% at the most recent evaluation&#xD;
             (prior to the index hospitalization).&#xD;
&#xD;
         12. History of cerebrovascular accident or transient ischemic attack in the last 6 months.&#xD;
&#xD;
         13. Active peptic ulcer or active gastrointestinal (GI) bleeding.&#xD;
&#xD;
         14. History of bleeding diathesis or coagulopathy or inability to accept blood&#xD;
             transfusions.&#xD;
&#xD;
         15. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin,&#xD;
             clopidogrel or ticlopidine, cobalt, nickel, or sensitivity to contrast media, which&#xD;
             cannot be adequately pre-medicated.&#xD;
&#xD;
         16. Known serum creatinine level &gt; 2.5 mg/dl, eGFR &lt;30, or hemodialysis dependent.&#xD;
&#xD;
        Angiographic Exclusion Criteria&#xD;
&#xD;
          1. Unprotected left main coronary artery disease (obstruction greater than 60% in the&#xD;
             left main coronary artery that is not protected by at least one non-obstructed bypass&#xD;
             graft to the left anterior descending (LAD) or left circumflex (LCX) artery or a&#xD;
             branch thereof).&#xD;
&#xD;
          2. Multi-vessel intervention required during the index procedure.&#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>Roxana Mehran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai Hospital, New York NY</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maurice Buchbinder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fouyndation Cardiovascular Research, La Jolla, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foundation Cardiovascular medicine</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>April 19, 2017</last_update_submitted>
  <last_update_submitted_qc>April 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>STEMI</keyword>
  <keyword>BMS</keyword>
  <keyword>Self-expanding stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01732341
org study id: STENTYS
nct id: NCT01732341
lead sponsor: 
has dmc: Yes
This study will test compare the Stentys Stent with the Multi-Link Vision™ stent system
      (Abbott Vascular Inc.)in patients with a heart attack. It is expected that the Stentys stent
      is not worse than the Vision stent.
Coronary artery disease continues to be the most common cause of morbidity and mortality in
      the occidental world. Treatment of coronary atherosclerotic disease has been significantly
      advanced by interventional cardiology, and in particular the advent of coronary arterial
      stents. In comparison to angioplasty alone, stents have reduced the incidence of angiographic
      as well as clinical restenosis, the recurrence of angina, the need for coronary arterial
      bypass graft (CABG) surgery, the need for repeat revascularization and the occurrence of
      major adverse cardiac events (MACE).However,problems remain due to failure to achieve optimal
      stent apposition and normal myocardial reperfusion. Early stent malapposition may be due to
      incomplete expansion or undersizing of balloon-expandable stents. Several studies have
      emphasized the importance of early malapposition in the setting of ST elevation MI, in which
      substantial thrombotic burden and the presence of diffuse vasoconstriction may be
      contributory. The Stentys Coronary Stent System includes a self-expanding bare metal
      (nitinol) stent on a rapid exchange (RX) delivery system. In view of the theoretical
      implications of malapposition, the self-expanding property may offer a potential benefit.

      This study is designed to evaluate the safety and effectiveness of the Stentys Coronary Stent
      System in the treatment of de novo stenotic lesions in coronary arteries in patients
      undergoing primary revascularization due to AMI as compared to the Multi-Link Vision™
      coronary stent system (Abbott Vascular Inc. The study is powered for non-inferiority of the
      Stentys Coronary Stent System compared to the Vision Stent System.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Target Vessel Failure
time frame: 12 months.
description: From date of randomization until the date of first documented TVF, assessed up to 12 months.
measure: Acute Stent Malapposition
time frame: Immediately after procedure
arm group label: STENTYS self-apposing stent
arm group type: Experimental
description: Intervention to treat STEMI with the STENTYS self-apposing stent
arm group label: VISION balloon-expandable stent
arm group type: Active Comparator
description: STEMI treatment with a VISION balloon-expandable stent
intervention type: Device
intervention name: STENTYS self-apposing stent
description: Intervention to treat STEMI with the STENTYS self-apposing stent
arm group label: STENTYS self-apposing stent
intervention type: Device
intervention name: VISION balloon-expandable stent
description: STEMI treatment with a VISION balloon-expandable stent
--------------------------------------------------------------------------------
arm group label: VISION balloon-expandable stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roxana Mehran, MD
role: Principal Investigator
affiliation: Mount Sinai Hospital, New York NY
last name: Maurice Buchbinder, MD
role: Principal Investigator
affiliation: Fouyndation Cardiovascular Research, La Jolla, CA
facility: 
facility: 
facility: 
country: Netherlands
country: United States
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction