<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/NCT02217501</url>
  </required_header>
  <id_info>
    <org_study_id>122013-065</org_study_id>
    <nct_id>NCT02217501</nct_id>
    <nct_alias>NCT02317822</nct_alias>
  </id_info>
  <brief_title>Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities</brief_title>
  <acronym>ASPIRE</acronym>
  <official_title>Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether clopidogrel 75 mg daily on a background of&#xD;
      aspirin 75-100 mg/d for clinically indicated duration or for an additional 12 months will&#xD;
      lead to an increased rate of primary patency, limb salvage, non-fatal myocardial infarction&#xD;
      (MI), ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at&#xD;
      end of study treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peripheral arterial disease (PAD) is extremely prevalent worldwide and affects over 206&#xD;
      million people. Over 36 million patients with PAD are estimated to be present in the United&#xD;
      States. Percutaneous revascularization therapies have evolved dramatically, yet the long-term&#xD;
      success of these therapies remains modest and the morbidity and mortality associated with PAD&#xD;
      remains high, with up to 30% mortality risk at 5 years. Nearly, 3.2 million endovascular&#xD;
      procedures are performed annually. Though, this exceeds interventional procedures performed&#xD;
      for coronary artery disease (CAD), the current PAD guidelines are silent regarding the need&#xD;
      and optimal duration of antiplatelet therapy (APT) for patients following an endovascular&#xD;
      procedure for claudication or critical limb ischemia (CLI). The lack of data and clinical&#xD;
      studies is by far the greatest impediment to the formulation of such guideline&#xD;
      recommendations critically needed by providers and patients alike, especially given the&#xD;
      current limited durability of lower extremity endovascular procedures.&#xD;
&#xD;
      The objective of this trial is to evaluate whether clopidogrel 75 mg QD on a background of&#xD;
      ASA 75-100 mg/d for clinically indicated duration or for an additional 12 months will lead to&#xD;
      an increased rate of primary patency, limb salvage, non-fatal myocardial infarction (MI),&#xD;
      ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at end of&#xD;
      study treatment.&#xD;
&#xD;
      The investigators hypothesize that dual antiplatelet therapy (DAPT) with ASA and clopidogrel&#xD;
      administered for an additional 12 months following iliac, femoropopliteal or below the knee&#xD;
      endovascular intervention will improve primary patency, limb salvage, freedom from ischemic&#xD;
      stroke and survival, in patients with symptomatic PAD.&#xD;
&#xD;
      Clinical endpoints will be analyzed in all subjects who are enrolled, regardless of whether&#xD;
      the trial treatment administered successfully completed for the desired duration. A subject&#xD;
      will be considered enrolled in the trial when he/she is randomized to one of the treatment&#xD;
      arms of the study. All endpoints are subject-based unless otherwise specified.&#xD;
&#xD;
      The primary endpoint is subject-based of the longer of a 12-month or end of study treatment&#xD;
      endpoint of the first occurrence of index limb arterial occlusion, surgical intervention,&#xD;
      endovascular intervention, amputation of the affected limb (primary patency and limb&#xD;
      salvage), MI, ischemic stroke or death (survival).&#xD;
&#xD;
      The secondary endpoints are subject-based on the longer of a 12 month or end of study&#xD;
      treatment endpoints that include: (a) the first occurrence of any individual component of the&#xD;
      primary endpoint, (b) the first occurrence of the following during follow-up: cardiovascular&#xD;
      death, or MI, or ischemic stroke, or any amputation above the ankle and (c) severe bleeding&#xD;
      defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator&#xD;
      for Occluded coronary arteries (GUSTO) classification.&#xD;
&#xD;
      The tertiary endpoint is based on the longer of a 12-month or end of study moderate bleeding&#xD;
      according to the GUSTO classification.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</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>Number of Participants With First Occurrence of Target Vessel Occlusion, Surgical Revascularization, Endovascular Revascularization, Major Amputation of Target Limb, Ischemic Stroke, MI, or Death</measure>
    <time_frame>12 months from index procedure or end of study treatment, whichever is longer, assessed up to 2 years</time_frame>
    <description>Occlusion of the target vessel documented by any imaging procedure (eg, Duplex ultrasonography scan including B mode imaging and Doppler ultrasound scan) at any follow-up visit within 12 months or end of study treatment period, whichever is longer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of Bleeding</measure>
    <time_frame>12 months from index procedure or end of study treatment, whichever is longer, assessed up to 2 years</time_frame>
    <description>Any mild, moderate, severe, or life-threatening bleeding.&#xD;
Severe or Life-threatening: Intracerebral hemorrhage Resulting in substantial hemodynamic compromise requiring treatment Moderate: Requiring blood transfusion but not resulting in hemodynamic compromise Mild: Bleeding that does not meet above criteria&#xD;
Severe bleeding defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO) classification.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>DAPT - clinically indicated duration+12m</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DAPT - clinically indicated duration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <description>Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months</description>
    <arm_group_label>DAPT - clinically indicated duration</arm_group_label>
    <arm_group_label>DAPT - clinically indicated duration+12m</arm_group_label>
    <other_name>Plavix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetylsalicylic acid (ASA)</intervention_name>
    <description>Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months</description>
    <arm_group_label>DAPT - clinically indicated duration</arm_group_label>
    <arm_group_label>DAPT - clinically indicated duration+12m</arm_group_label>
    <other_name>Aspirin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        General:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  Documented symptomatic iliac, femoropopliteal (FP) or below-the knee artery (BTK)&#xD;
             atherosclerotic disease (Rutherford/Becker category 2, 3 or ≥4)&#xD;
&#xD;
          -  Undergone clinically indicated uncomplicated endovascular intervention to one or more&#xD;
             locations of the iliac, femoropopliteal below-the knee arteries&#xD;
&#xD;
          -  Estimated survival ≥1 year in the judgment of the primary operator&#xD;
&#xD;
          -  Pre-index procedure use of ASA, clopidogrel or both at any dose&#xD;
&#xD;
        Angiographic:&#xD;
&#xD;
          -  De novo or restenotic lesions in the common and/or external iliac artery, superficial&#xD;
             femoral artery (SFA), popliteal artery, tibio-peroneal (TP) trunk, anterior tibial&#xD;
             (AT) artery, peroneal artery (PA) or posterior tibial (PT) artery (applies to all&#xD;
             target lesions if multiple)&#xD;
&#xD;
          -  Subjects with multiple planned procedures can be enrolled after the completion of the&#xD;
             last planned procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General:&#xD;
&#xD;
          -  Complicated qualifying procedure (perforation, flow limiting dissection, distal&#xD;
             embolization requiring re-intervention, need for repeat endovascular, surgical&#xD;
             revascularization, amputation or blood transfusion prior to hospital discharge&#xD;
             following an index procedure&#xD;
&#xD;
          -  Extended hospital stay &gt;7 days following the index procedure&#xD;
&#xD;
          -  Allergy to aspirin or clopidogrel&#xD;
&#xD;
          -  Life expectancy less than 12 months due to other medical co-morbid condition(s) that&#xD;
             could limit the subject's ability to participate in the trial, limit the subject's&#xD;
             compliance with the follow-up requirements, or impact the scientific integrity of the&#xD;
             trial&#xD;
&#xD;
          -  Known hypersensitivity or contraindication to contrast dye that, in the opinion of the&#xD;
             investigator, cannot be adequately pre-medicated.&#xD;
&#xD;
          -  Intolerance to antiplatelet, anticoagulant, or thrombolytic medications&#xD;
&#xD;
          -  Platelet count &lt;90,000 mm3 or &gt;600,000 mm3&#xD;
&#xD;
          -  Serum creatinine &gt;2.5 mg/dL&#xD;
&#xD;
          -  Dialysis-dependent end stage renal disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current participation in another drug or device trial that requires interruption of&#xD;
             dual-antiplatelet therapy with aspirin or clopidogrel for the duration of the study&#xD;
&#xD;
          -  Planned surgeries, endovascular or other non-vascular or cardiac procedures&#xD;
&#xD;
          -  Concurrent warfarin or other chronic oral anticoagulant therapy&#xD;
&#xD;
          -  Contraindication(s) to the use of AT (history of intra-cerebral bleed, presence of&#xD;
             intra-cerebral mass, recent or &lt;6 weeks gastrointestinal bleed, blood transfusion&#xD;
             within the last 6 weeks, any trauma requiring surgery or blood transfusion within the&#xD;
             last 4 weeks or any surgical procedure within the last 4 weeks.&#xD;
&#xD;
        Angiographic:&#xD;
&#xD;
          -  Endovascular intervention to iliac, femoropopliteal or BTK artery bypass graft&#xD;
&#xD;
          -  Persistent, intraluminal thrombus of the proposed target lesion at the completion of&#xD;
             the index procedure&#xD;
&#xD;
          -  Perforated vessel as evidenced by extravasation of contrast media&#xD;
&#xD;
          -  Vascular graft, aneurysm or postsurgical stenosis of the target vessel&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Subhash Banerjee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Subhash Banerjee, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Denver VA Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Cardiovascular Research Foundation</name>
      <address>
        <city>Davenport</city>
        <state>Iowa</state>
        <zip>52803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA North Texas Health Care System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hirsch AT, Duval S. The global pandemic of peripheral artery disease. Lancet. 2013 Oct 19;382(9901):1312-4. doi: 10.1016/S0140-6736(13)61576-7. Epub 2013 Aug 1. No abstract available.</citation>
    <PMID>23915884</PMID>
  </reference>
  <reference>
    <citation>Parikh SV, Saya S, Divanji P, Banerjee S, Selzer F, Abbott JD, Naidu SS, Wilensky RL, Faxon DP, Jacobs AK, Holper EM. Risk of death and myocardial infarction in patients with peripheral arterial disease undergoing percutaneous coronary intervention (from the National Heart, Lung and Blood Institute Dynamic Registry). Am J Cardiol. 2011 Apr 1;107(7):959-64. doi: 10.1016/j.amjcard.2010.11.019. Epub 2011 Jan 20.</citation>
    <PMID>21256469</PMID>
  </reference>
  <reference>
    <citation>Diehm C, Schuster A, Allenberg JR, Darius H, Haberl R, Lange S, Pittrow D, von Stritzky B, Tepohl G, Trampisch HJ. High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: cross-sectional study. Atherosclerosis. 2004 Jan;172(1):95-105. doi: 10.1016/s0021-9150(03)00204-1.</citation>
    <PMID>14709362</PMID>
  </reference>
  <reference>
    <citation>Hankey GJ, Norman PE, Eikelboom JW. Medical treatment of peripheral arterial disease. JAMA. 2006 Feb 1;295(5):547-53. doi: 10.1001/jama.295.5.547.</citation>
    <PMID>16449620</PMID>
  </reference>
  <reference>
    <citation>Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery/Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines. ACC/AHA Guidelines for the Management of Patients with Peripheral Arterial Disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Associations for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (writing committee to develop guidelines for the management of patients with peripheral arterial disease)--summary of recommendations. J Vasc Interv Radiol. 2006 Sep;17(9):1383-97; quiz 1398. doi: 10.1097/01.RVI.0000240426.53079.46. No abstract available.</citation>
    <PMID>16990459</PMID>
  </reference>
  <reference>
    <citation>Banerjee S, Das TS, Abu-Fadel MS, Dippel EJ, Shammas NW, Tran DL, Zankar A, Varghese C, Kelly KC, Weideman RA, Little BB, Reilly RF, Addo T, Brilakis ES. Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial. J Am Coll Cardiol. 2012 Oct 9;60(15):1352-9. doi: 10.1016/j.jacc.2012.05.042. Epub 2012 Sep 12.</citation>
    <PMID>22981558</PMID>
  </reference>
  <reference>
    <citation>Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.</citation>
    <PMID>16549646</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>December 27, 2020</results_first_submitted>
  <results_first_submitted_qc>February 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2021</results_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Subhash Banerjee</investigator_full_name>
    <investigator_title>PROFESSOR</investigator_title>
  </responsible_party>
  <keyword>peripheral arterial disease, antiplatelet therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Clopidogrel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study results will be posted on clinical.trials.gov and through publications and presentations</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT02217501/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DAPT - Clinically Indicated Duration+12m</title>
          <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months&#xD;
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months&#xD;
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months</description>
        </group>
        <group group_id="P2">
          <title>DAPT - Clinically Indicated Duration</title>
          <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days&#xD;
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration&#xD;
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="82"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>DAPT - Clinically Indicated Duration+12m</title>
          <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months&#xD;
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months&#xD;
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months</description>
        </group>
        <group group_id="B2">
          <title>DAPT - Clinically Indicated Duration</title>
          <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days&#xD;
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration&#xD;
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="77"/>
            <count group_id="B2" value="82"/>
            <count group_id="B3" value="159"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="77"/>
                    <count group_id="B2" value="82"/>
                    <count group_id="B3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.62" spread="8.82"/>
                    <measurement group_id="B2" value="65.27" spread="8.90"/>
                    <measurement group_id="B3" value="65.44" spread="9.00"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="77"/>
                    <count group_id="B2" value="82"/>
                    <count group_id="B3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With First Occurrence of Target Vessel Occlusion, Surgical Revascularization, Endovascular Revascularization, Major Amputation of Target Limb, Ischemic Stroke, MI, or Death</title>
        <description>Occlusion of the target vessel documented by any imaging procedure (eg, Duplex ultrasonography scan including B mode imaging and Doppler ultrasound scan) at any follow-up visit within 12 months or end of study treatment period, whichever is longer.</description>
        <time_frame>12 months from index procedure or end of study treatment, whichever is longer, assessed up to 2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DAPT - Clinically Indicated Duration+12m</title>
            <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months&#xD;
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months&#xD;
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months</description>
          </group>
          <group group_id="O2">
            <title>DAPT - Clinically Indicated Duration</title>
            <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days&#xD;
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration&#xD;
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Target Vessel Occlusion, Surgical Revascularization, Endovascular Revascularization, Major Amputation of Target Limb, Ischemic Stroke, MI, or Death</title>
          <description>Occlusion of the target vessel documented by any imaging procedure (eg, Duplex ultrasonography scan including B mode imaging and Doppler ultrasound scan) at any follow-up visit within 12 months or end of study treatment period, whichever is longer.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of Bleeding</title>
        <description>Any mild, moderate, severe, or life-threatening bleeding.&#xD;
Severe or Life-threatening: Intracerebral hemorrhage Resulting in substantial hemodynamic compromise requiring treatment Moderate: Requiring blood transfusion but not resulting in hemodynamic compromise Mild: Bleeding that does not meet above criteria&#xD;
Severe bleeding defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO) classification.</description>
        <time_frame>12 months from index procedure or end of study treatment, whichever is longer, assessed up to 2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DAPT - Clinically Indicated Duration+12m</title>
            <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months&#xD;
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months&#xD;
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months</description>
          </group>
          <group group_id="O2">
            <title>DAPT - Clinically Indicated Duration</title>
            <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days&#xD;
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration&#xD;
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Bleeding</title>
          <description>Any mild, moderate, severe, or life-threatening bleeding.&#xD;
Severe or Life-threatening: Intracerebral hemorrhage Resulting in substantial hemodynamic compromise requiring treatment Moderate: Requiring blood transfusion but not resulting in hemodynamic compromise Mild: Bleeding that does not meet above criteria&#xD;
Severe bleeding defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO) classification.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6595</p_value>
            <p_value_desc>Alpha of 0.05</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the time on informed consent and up to 18 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>DAPT - Clinically Indicated Duration+12m</title>
          <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months&#xD;
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months&#xD;
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months</description>
        </group>
        <group group_id="E2">
          <title>DAPT - Clinically Indicated Duration</title>
          <description>Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days&#xD;
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration&#xD;
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration</description>
        </group>
      </group_list>
      <serious_events>
        <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="3" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Bleeding</sub_title>
                <description>Bleeding required to be hospitalized.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Amputation</sub_title>
                <description>Amputation (major and minor)</description>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="77"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Bleeding requiring transfusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Repeat Endovascular Revascularization</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="77"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="1" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>CT/MR Angiography</sub_title>
                <description>CT/ MR Angiography</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Study was not able to reach the target number of participants needed to achieve target power and statistically reliable results.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Subhash Banerjee, MD</name_or_title>
      <organization>UT Southwestern Medical Center</organization>
      <phone>214-857-1608</phone>
      <email>Subhash.Banerjee@utsouthwestern.edu</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/NCT02217501
org study id: 122013-065
nct id: NCT02217501
nct alias: NCT02317822
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate whether clopidogrel 75 mg daily on a background of
      aspirin 75-100 mg/d for clinically indicated duration or for an additional 12 months will
      lead to an increased rate of primary patency, limb salvage, non-fatal myocardial infarction
      (MI), ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at
      end of study treatment.
Peripheral arterial disease (PAD) is extremely prevalent worldwide and affects over 206
      million people. Over 36 million patients with PAD are estimated to be present in the United
      States. Percutaneous revascularization therapies have evolved dramatically, yet the long-term
      success of these therapies remains modest and the morbidity and mortality associated with PAD
      remains high, with up to 30% mortality risk at 5 years. Nearly, 3.2 million endovascular
      procedures are performed annually. Though, this exceeds interventional procedures performed
      for coronary artery disease (CAD), the current PAD guidelines are silent regarding the need
      and optimal duration of antiplatelet therapy (APT) for patients following an endovascular
      procedure for claudication or critical limb ischemia (CLI). The lack of data and clinical
      studies is by far the greatest impediment to the formulation of such guideline
      recommendations critically needed by providers and patients alike, especially given the
      current limited durability of lower extremity endovascular procedures.

      The objective of this trial is to evaluate whether clopidogrel 75 mg QD on a background of
      ASA 75-100 mg/d for clinically indicated duration or for an additional 12 months will lead to
      an increased rate of primary patency, limb salvage, non-fatal myocardial infarction (MI),
      ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at end of
      study treatment.

      The investigators hypothesize that dual antiplatelet therapy (DAPT) with ASA and clopidogrel
      administered for an additional 12 months following iliac, femoropopliteal or below the knee
      endovascular intervention will improve primary patency, limb salvage, freedom from ischemic
      stroke and survival, in patients with symptomatic PAD.

      Clinical endpoints will be analyzed in all subjects who are enrolled, regardless of whether
      the trial treatment administered successfully completed for the desired duration. A subject
      will be considered enrolled in the trial when he/she is randomized to one of the treatment
      arms of the study. All endpoints are subject-based unless otherwise specified.

      The primary endpoint is subject-based of the longer of a 12-month or end of study treatment
      endpoint of the first occurrence of index limb arterial occlusion, surgical intervention,
      endovascular intervention, amputation of the affected limb (primary patency and limb
      salvage), MI, ischemic stroke or death (survival).

      The secondary endpoints are subject-based on the longer of a 12 month or end of study
      treatment endpoints that include: (a) the first occurrence of any individual component of the
      primary endpoint, (b) the first occurrence of the following during follow-up: cardiovascular
      death, or MI, or ischemic stroke, or any amputation above the ankle and (c) severe bleeding
      defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator
      for Occluded coronary arteries (GUSTO) classification.

      The tertiary endpoint is based on the longer of a 12-month or end of study moderate bleeding
      according to the GUSTO classification.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With First Occurrence of Target Vessel Occlusion, Surgical Revascularization, Endovascular Revascularization, Major Amputation of Target Limb, Ischemic Stroke, MI, or Death
time frame: 12 months from index procedure or end of study treatment, whichever is longer, assessed up to 2 years
description: Occlusion of the target vessel documented by any imaging procedure (eg, Duplex ultrasonography scan including B mode imaging and Doppler ultrasound scan) at any follow-up visit within 12 months or end of study treatment period, whichever is longer.
measure: Number of Participants With First Occurrence of Bleeding
time frame: 12 months from index procedure or end of study treatment, whichever is longer, assessed up to 2 years
description: Any mild, moderate, severe, or life-threatening bleeding.
Severe or Life-threatening: Intracerebral hemorrhage Resulting in substantial hemodynamic compromise requiring treatment Moderate: Requiring blood transfusion but not resulting in hemodynamic compromise Mild: Bleeding that does not meet above criteria
Severe bleeding defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO) classification.
arm group label: DAPT - clinically indicated duration+12m
arm group type: Experimental
description: Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months
arm group label: DAPT - clinically indicated duration
arm group type: Active Comparator
description: Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days
intervention type: Drug
intervention name: Clopidogrel
description: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
arm group label: DAPT - clinically indicated duration
arm group label: DAPT - clinically indicated duration+12m
other name: Plavix
intervention type: Drug
intervention name: Acetylsalicylic acid (ASA)
description: Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
arm group label: DAPT - clinically indicated duration
arm group label: DAPT - clinically indicated duration+12m
other name: Aspirin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Subhash Banerjee, MD
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
last name: Subhash Banerjee, MD
role: Study Chair
affiliation: University of Texas Southwestern Medical Center
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Hirsch AT, Duval S. The global pandemic of peripheral artery disease. Lancet. 2013 Oct 19;382(9901):1312-4. doi: 10.1016/S0140-6736(13)61576-7. Epub 2013 Aug 1. No abstract available.
PMID: 23915884
citation: Parikh SV, Saya S, Divanji P, Banerjee S, Selzer F, Abbott JD, Naidu SS, Wilensky RL, Faxon DP, Jacobs AK, Holper EM. Risk of death and myocardial infarction in patients with peripheral arterial disease undergoing percutaneous coronary intervention (from the National Heart, Lung and Blood Institute Dynamic Registry). Am J Cardiol. 2011 Apr 1;107(7):959-64. doi: 10.1016/j.amjcard.2010.11.019. Epub 2011 Jan 20.
PMID: 21256469
citation: Diehm C, Schuster A, Allenberg JR, Darius H, Haberl R, Lange S, Pittrow D, von Stritzky B, Tepohl G, Trampisch HJ. High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: cross-sectional study. Atherosclerosis. 2004 Jan;172(1):95-105. doi: 10.1016/s0021-9150(03)00204-1.
PMID: 14709362
citation: Hankey GJ, Norman PE, Eikelboom JW. Medical treatment of peripheral arterial disease. JAMA. 2006 Feb 1;295(5):547-53. doi: 10.1001/jama.295.5.547.
PMID: 16449620
citation: Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery/Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines. ACC/AHA Guidelines for the Management of Patients with Peripheral Arterial Disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Associations for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (writing committee to develop guidelines for the management of patients with peripheral arterial disease)--summary of recommendations. J Vasc Interv Radiol. 2006 Sep;17(9):1383-97; quiz 1398. doi: 10.1097/01.RVI.0000240426.53079.46. No abstract available.
PMID: 16990459
citation: Banerjee S, Das TS, Abu-Fadel MS, Dippel EJ, Shammas NW, Tran DL, Zankar A, Varghese C, Kelly KC, Weideman RA, Little BB, Reilly RF, Addo T, Brilakis ES. Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial. J Am Coll Cardiol. 2012 Oct 9;60(15):1352-9. doi: 10.1016/j.jacc.2012.05.042. Epub 2012 Sep 12.
PMID: 22981558
citation: Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
PMID: 16549646
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Subhash Banerjee
investigator title: PROFESSOR
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Aspirin
mesh term: Clopidogrel
sharing ipd: Yes
ipd description: Study results will be posted on clinical.trials.gov and through publications and presentations
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study was not able to reach the target number of participants needed to achieve target power and statistically reliable results.
point of contact: 