<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/NCT03241459</url>
  </required_header>
  <id_info>
    <org_study_id>SUR17-001</org_study_id>
    <nct_id>NCT03241459</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of the SurVeil™ Drug-Coated Balloon</brief_title>
  <acronym>TRANSCEND</acronym>
  <official_title>The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil™ Drug-Coated Balloon iN the Treatment of Subjects With Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® Drug-Coated Balloon</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SurModics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SurModics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment&#xD;
      of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral&#xD;
      and/or popliteal arteries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      TRANSCEND is a prospective, multi-center, single-blind, randomized, controlled,&#xD;
      noninferiority clinical trial. The trial will randomize approximately 446 subjects with&#xD;
      symptomatic PAD due to stenoses of the femoral and/or popliteal arteries. Subjects meeting&#xD;
      eligibility criteria will be randomized 1:1 to treatment with either the SurVeil DCB or the&#xD;
      IN.PACT Admiral DCB, and followed for 60 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Actual">September 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Lesion Patency</measure>
    <time_frame>12 months</time_frame>
    <description>Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound [DUS] peak systolic velocity ratio [PSVR] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety composite of death, amputation, and target vessel revascularization (TVR)</measure>
    <time_frame>12 months</time_frame>
    <description>Composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven TVR through 12 months post-index procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device Success</measure>
    <time_frame>Day 0</time_frame>
    <description>Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure, and achievement of &lt;50% residual stenosis of the target lesion (by core lab-assessed quantitative angiography [QA]) without flow-limiting arterial dissection using only the study device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Success</measure>
    <time_frame>Day 0</time_frame>
    <description>Defined as achievement of a final residual diameter stenosis of &lt;50% (by core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Success</measure>
    <time_frame>72 hours</time_frame>
    <description>Defined as evidence of both acute technical success and absence of Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 hours of the index procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Success</measure>
    <time_frame>30 days</time_frame>
    <description>Freedom from all-cause death, major target limb amputation and TVR through 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Lesion Patency</measure>
    <time_frame>24 months</time_frame>
    <description>Applicable only if both the primary safety and efficacy hypotheses of noninferiority are met.&#xD;
Primary patency defined as a composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound [DUS] peak systolic velocity ratio [PSVR] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel Patency</measure>
    <time_frame>12 months, 24 months</time_frame>
    <description>Defined as freedom from clinically-driven TVR and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained Clinical Improvement</measure>
    <time_frame>6 months, 12 months, 24 months</time_frame>
    <description>Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically-driven TLR</measure>
    <time_frame>6 months, 12 months, 24 months, 36 months, 48 months, and 60 months</time_frame>
    <description>Clinically-driven target lesion revascularization, within 6, 12, 24, 36, 48, and 60 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Historical MAEs</measure>
    <time_frame>6 months, 12 months, 24 months, 36 months, 48 months, and 60 months</time_frame>
    <description>Major Adverse Events (MAEs) defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, within 6, 12, 24, 36, 48, and 60 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major amputation</measure>
    <time_frame>6 months, 12 months, 24 months, 36 months, 48 months, and 60 months</time_frame>
    <description>Major target limb amputation, within 6, 12, 24, 36, 48, and 60 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombosis</measure>
    <time_frame>6 months, 12 months, 24 months, 36 months, 48 months, and 60 months</time_frame>
    <description>Thrombosis at target limb, within 6, 12, 24, 36, 48, and 60 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutherford Class</measure>
    <time_frame>Screening, 1 month, 6 months, 12 months, and 24 months</time_frame>
    <description>Change in target limb Rutherford class from baseline to 1, 6, 12, and 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PARC Class</measure>
    <time_frame>Screening, 1 month, 6 months, 12 months, and 24 months</time_frame>
    <description>Change in target limb PARC class from baseline to 1, 6, 12, and 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle Brachial Index (ABI)</measure>
    <time_frame>Screening, 6 months, 12 months, and 24 months</time_frame>
    <description>Decrease in target limb ABI or toe brachial index ≥0.15 from baseline to 6, 12, and 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Impairment Questionnaire (WIQ)</measure>
    <time_frame>Screening, 1 month, 12 months, and 24 months</time_frame>
    <description>Change in WIQ score from baseline to 1, 12, and 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six Minute Walk Test (6MWT)</measure>
    <time_frame>Screening, 12 months, and 24 months</time_frame>
    <description>Change in 6MWT from baseline to 12 and 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral Artery Questionnaire (PAQ)</measure>
    <time_frame>Screening, 1 month, 12 months, and 24 months</time_frame>
    <description>Change in PAQ score from baseline to 1, 12, and 24 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">446</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Peripheral Vascular Disease</condition>
  <condition>Artery Disease, Peripheral</condition>
  <condition>Femoropopliteal Artery Occlusion</condition>
  <arm_group>
    <arm_group_label>Surmodics SurVeil DCB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medtronic IN.PACT Admiral DCB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surmodics SurVeil DCB</intervention_name>
    <description>Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.</description>
    <arm_group_label>Surmodics SurVeil DCB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic IN.PACT Admiral DCB</intervention_name>
    <description>Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.</description>
    <arm_group_label>Medtronic IN.PACT Admiral DCB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is ≥18 years.&#xD;
&#xD;
          -  Subject has target limb Rutherford classification 2, 3 or 4.&#xD;
&#xD;
          -  Subject has provided written informed consent and is willing to comply with study&#xD;
             follow-up requirements.&#xD;
&#xD;
          -  De novo lesion(s) or non-stented restenotic lesion(s) occurring &gt;90 days after prior&#xD;
             plain old balloon (POBA) angioplasty or &gt;180 days after prior DCB treatment.&#xD;
&#xD;
          -  Target lesion location starts ≥10 mm below the common femoral bifurcation and&#xD;
             terminates distally at or above the end of the P1 segment of the popliteal artery.&#xD;
&#xD;
          -  Target vessel diameter ≥4 mm and ≤7 mm.&#xD;
&#xD;
          -  Target lesion must have angiographic evidence of ≥70% stenosis by operator visual&#xD;
             estimate.&#xD;
&#xD;
          -  Chronic total occlusions may be included only after successful, uncomplicated wire&#xD;
             crossing of target lesion via an anterograde approach and without the use of&#xD;
             subintimal dissection techniques.&#xD;
&#xD;
          -  Target lesion must be ≤180 mm in length (one long lesion or multiple serial lesions)&#xD;
             by operator visual estimate. Note: combination lesions must have a total lesion length&#xD;
             of ≤180 mm by visual estimate and be separated by ≤30 mm.&#xD;
&#xD;
          -  Target lesion is located at least 30 mm from any stent, if target vessel was&#xD;
             previously stented.&#xD;
&#xD;
          -  Successful, uncomplicated (without use of a crossing device) wire crossing of target&#xD;
             lesion. Successful crossing of the target lesion occurs when the tip of the guide wire&#xD;
             is distal to the target lesion without the occurrence of flow-limiting dissection or&#xD;
             perforation and is judged by visual inspection to be within the true lumen.&#xD;
&#xD;
          -  After pre-dilatation, the target lesion is ≤70% residual stenosis, absence of a flow&#xD;
             limiting dissection and treatable with available device matrix.&#xD;
&#xD;
          -  A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by&#xD;
             angiography.&#xD;
&#xD;
          -  At least one patent native outflow artery to the ankle or foot, free from significant&#xD;
             stenosis (≥50% stenosis) as confirmed by angiography.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has acute limb ischemia.&#xD;
&#xD;
          -  Subject underwent percutaneous transluminal angioplasty (PTA) of the target limb using&#xD;
             plain old balloon angioplasty (POBA) or a stent within the previous 90 days.&#xD;
&#xD;
          -  Subject underwent any lower extremity percutaneous treatment using a&#xD;
             paclitaxel-eluting stent or a DCB within the previous 90 days.&#xD;
&#xD;
          -  Subject underwent PTA of the target lesion using a DCB within the previous 180 days.&#xD;
&#xD;
          -  Subject has had prior vascular intervention in the contralateral limb within 14 days&#xD;
             before the planned study index procedure or subject has planned vascular intervention&#xD;
             in the contralateral limb within 30 days after the index procedure.&#xD;
&#xD;
          -  Subject is pregnant, breast-feeding or intends to become pregnant during the time of&#xD;
             the study.&#xD;
&#xD;
          -  Subject has life expectancy less than 2 years.&#xD;
&#xD;
          -  Subject has a known allergy to contrast medium that cannot be adequately&#xD;
             pre-medicated.&#xD;
&#xD;
          -  Subject is allergic to ALL antiplatelet treatments.&#xD;
&#xD;
          -  Subject has impaired renal function (i.e. serum creatinine level ≥2.5 mg/dL).&#xD;
&#xD;
          -  Subject is dialysis dependent.&#xD;
&#xD;
          -  Subject is receiving immunosuppressant therapy.&#xD;
&#xD;
          -  Subject has known or suspected active infection at the time of the index procedure.&#xD;
&#xD;
          -  Subject has platelet count &lt;100,000/mm3 or &gt;700,000/mm3.&#xD;
&#xD;
          -  Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3&#xD;
             months prior to the study procedure.&#xD;
&#xD;
          -  Subject is diagnosed with coagulopathy that precludes treatment with systemic&#xD;
             anticoagulation and/or dual antiplatelet therapy (DAPT).&#xD;
&#xD;
          -  Subject has history of stroke within the past 90 days.&#xD;
&#xD;
          -  Subject has a history of myocardial infarction within the past 30 days.&#xD;
&#xD;
          -  Subject is unable to tolerate blood transfusions because of religious beliefs or other&#xD;
             reasons.&#xD;
&#xD;
          -  Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol.&#xD;
&#xD;
          -  Subject is participating in another investigational drug or medical device study that&#xD;
             has not completed primary endpoint(s) evaluation or that clinically interferes with&#xD;
             the endpoints from this study, or subject is planning to participate in such studies&#xD;
             prior to the completion of this study.&#xD;
&#xD;
          -  Subject has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or&#xD;
             intervention unrelated to this study within 30 days prior to the index procedure or&#xD;
             has planned major surgical procedure or intervention within 30 days of the index&#xD;
             procedure.&#xD;
&#xD;
          -  Subject had previous bypass surgery of the target lesion.&#xD;
&#xD;
          -  Subject had previous treatment of the target vessel with thrombolysis or surgery.&#xD;
&#xD;
          -  Subject is unwilling or unable to comply with procedures specified in the protocol or&#xD;
             has difficulty or inability to return for follow-up visits as specified by the&#xD;
             protocol.&#xD;
&#xD;
          -  Target lesion has severe calcification (as defined by the PARC classification of&#xD;
             calcification).&#xD;
&#xD;
          -  Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm).&#xD;
&#xD;
          -  Target lesion requires treatment with alternative therapy such as stenting, laser,&#xD;
             atherectomy, cryoplasty, brachytherapy, re-entry devices, or subintimal dissection&#xD;
             techniques.&#xD;
&#xD;
          -  Significant target vessel tortuosity or other parameters prohibiting access to the&#xD;
             target lesion.&#xD;
&#xD;
          -  Presence of thrombus in the target vessel.&#xD;
&#xD;
          -  Iliac inflow disease requiring treatment, unless the iliac artery disease is&#xD;
             successfully treated first during the index procedure. Success is defined as ≤30%&#xD;
             residual diameter stenosis without death or major complications.&#xD;
&#xD;
          -  Presence of an aortic, iliac or femoral artificial graft.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Gray, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lankenau Heart Group</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kenneth Rosenfield, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marianne Brodmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Graz, Department of Internal Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiovascular Associates of the Southeast</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates</name>
      <address>
        <city>Foley</city>
        <state>Alabama</state>
        <zip>36535</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Health</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85297</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuma Regional Medical Center</name>
      <address>
        <city>Yuma</city>
        <state>Arizona</state>
        <zip>85364</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clearwater Cardiovascular Consultants</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advent Health Ocala/MediQuest Research Group LLC (formerly FL Hospital /Munroe)</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Heart Insitute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital (Clifton)</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Medical Center</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexian Brothers Medical Center</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Health</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prairie Education (PERC)</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent Heart (Research Department)</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Heart Center</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endovascular Technologies, LLC</name>
      <address>
        <city>Bossier City</city>
        <state>Louisiana</state>
        <zip>71111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Associates Research</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elizabeth's Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Michigan Hospital</name>
      <address>
        <city>Petoskey</city>
        <state>Michigan</state>
        <zip>49770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Memorial Hospital</name>
      <address>
        <city>Robbinsdale</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hattiesburg Clinic</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua Medical Group, P.A.</name>
      <address>
        <city>Cherry Hill</city>
        <state>New Jersey</state>
        <zip>08034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07102</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>Columbia University Medical Center/NYPH</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Hospital</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moses Cone-LeBauer</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Carolina Heart and Vascular</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Lindner Clinical Trial Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Health Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Ohio Heart Center</name>
      <address>
        <city>Elyria</city>
        <state>Ohio</state>
        <zip>44035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toledo Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Cardiovascular Research Group</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Heart and Vascular</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital Area Research</name>
      <address>
        <city>Camp Hill</city>
        <state>Pennsylvania</state>
        <zip>17011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bryn Mawr Hospital - Main Line Health System (Einstein)</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Health Cardiovascular Institute</name>
      <address>
        <city>Wormleysburg</city>
        <state>Pennsylvania</state>
        <zip>17043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ballad Health System</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turkey Creek Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37934</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. David's Heart &amp; Vascular PLLC dba Austin Heart</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Cardiovascular Association</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Dallas Research Associates</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Private Hostpital</name>
      <address>
        <city>Randwick</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institution Medizinische Universitat</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Blasius</name>
      <address>
        <city>Dendermonde</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ GENT</name>
      <address>
        <city>Ghent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FN u sv. Anny v Brně a LF MU (Centrum cévních onemocnění II. chirurgická klinika)</name>
      <address>
        <city>Brno</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitkovicka Nemocnice Ostrava Vítkovická nemocnice, a.s.,</name>
      <address>
        <city>Ostrava</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz Zentrum Bad Krozingen Südring</name>
      <address>
        <city>Bad Krozingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SRH Klinikum KarlsbadLangensteinbach</name>
      <address>
        <city>Karlsbad</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>REGIOMED-KLINIKEN GmbH</name>
      <address>
        <city>Sonneberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aou Careggi University Hospital</name>
      <address>
        <city>Florence</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pauls Stradins Clinical University Hospital</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Latvia</country>
    <country>New Zealand</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Singapore</country>
    <country>Switzerland</country>
  </removed_countries>
  <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>
  <reference>
    <citation>Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.</citation>
    <PMID>17140820</PMID>
  </reference>
  <reference>
    <citation>Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. doi: 10.1016/j.jacc.2015.09.063. Epub 2015 Oct 14.</citation>
    <PMID>26476467</PMID>
  </reference>
  <reference>
    <citation>Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Muller-Hulsbeck S, Nehler MR, Benenati JF, Scheinert D; LEVANT 2 Investigators. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. 2015 Jul 9;373(2):145-53. doi: 10.1056/NEJMoa1406235. Epub 2015 Jun 24.</citation>
    <PMID>26106946</PMID>
  </reference>
  <reference>
    <citation>Patel MR, Conte MS, Cutlip DE, Dib N, Geraghty P, Gray W, Hiatt WR, Ho M, Ikeda K, Ikeno F, Jaff MR, Jones WS, Kawahara M, Lookstein RA, Mehran R, Misra S, Norgren L, Olin JW, Povsic TJ, Rosenfield K, Rundback J, Shamoun F, Tcheng J, Tsai TT, Suzuki Y, Vranckx P, Wiechmann BN, White CJ, Yokoi H, Krucoff MW. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015 Mar 10;65(9):931-41. doi: 10.1016/j.jacc.2014.12.036. Erratum In: J Am Coll Cardiol. 2015 Jun 16;65(23):2578-9.</citation>
    <PMID>25744011</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <disposition_first_submitted>September 8, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>September 10, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 14, 2021</disposition_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Percutaneous Transluminal Angioplasty</keyword>
  <keyword>PTA</keyword>
  <keyword>Peripheral Artery Disease</keyword>
  <keyword>PAD</keyword>
  <keyword>Paclitaxel</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>
    <mesh_term>Vascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 23, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03241459
org study id: SUR17-001
nct id: NCT03241459
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment
      of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral
      and/or popliteal arteries.
TRANSCEND is a prospective, multi-center, single-blind, randomized, controlled,
      noninferiority clinical trial. The trial will randomize approximately 446 subjects with
      symptomatic PAD due to stenoses of the femoral and/or popliteal arteries. Subjects meeting
      eligibility criteria will be randomized 1:1 to treatment with either the SurVeil DCB or the
      IN.PACT Admiral DCB, and followed for 60 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Primary Lesion Patency
time frame: 12 months
description: Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound [DUS] peak systolic velocity ratio [PSVR] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.
measure: Safety composite of death, amputation, and target vessel revascularization (TVR)
time frame: 12 months
description: Composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven TVR through 12 months post-index procedure.
measure: Device Success
time frame: Day 0
description: Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure, and achievement of <50% residual stenosis of the target lesion (by core lab-assessed quantitative angiography [QA]) without flow-limiting arterial dissection using only the study device.
measure: Technical Success
time frame: Day 0
description: Defined as achievement of a final residual diameter stenosis of <50% (by core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure.
measure: Procedure Success
time frame: 72 hours
description: Defined as evidence of both acute technical success and absence of Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 hours of the index procedure.
measure: Clinical Success
time frame: 30 days
description: Freedom from all-cause death, major target limb amputation and TVR through 30 days
measure: Primary Lesion Patency
time frame: 24 months
description: Applicable only if both the primary safety and efficacy hypotheses of noninferiority are met.
Primary patency defined as a composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound [DUS] peak systolic velocity ratio [PSVR] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs).
measure: Target Vessel Patency
time frame: 12 months, 24 months
description: Defined as freedom from clinically-driven TVR and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs).
measure: Sustained Clinical Improvement
time frame: 6 months, 12 months, 24 months
description: Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.
measure: Clinically-driven TLR
time frame: 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months
description: Clinically-driven target lesion revascularization, within 6, 12, 24, 36, 48, and 60 months
measure: Historical MAEs
time frame: 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months
description: Major Adverse Events (MAEs) defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, within 6, 12, 24, 36, 48, and 60 months.
measure: Major amputation
time frame: 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months
description: Major target limb amputation, within 6, 12, 24, 36, 48, and 60 months.
measure: Thrombosis
time frame: 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months
description: Thrombosis at target limb, within 6, 12, 24, 36, 48, and 60 months.
measure: Rutherford Class
time frame: Screening, 1 month, 6 months, 12 months, and 24 months
description: Change in target limb Rutherford class from baseline to 1, 6, 12, and 24 months.
measure: PARC Class
time frame: Screening, 1 month, 6 months, 12 months, and 24 months
description: Change in target limb PARC class from baseline to 1, 6, 12, and 24 months.
measure: Ankle Brachial Index (ABI)
time frame: Screening, 6 months, 12 months, and 24 months
description: Decrease in target limb ABI or toe brachial index ≥0.15 from baseline to 6, 12, and 24 months.
measure: Walking Impairment Questionnaire (WIQ)
time frame: Screening, 1 month, 12 months, and 24 months
description: Change in WIQ score from baseline to 1, 12, and 24 months.
measure: Six Minute Walk Test (6MWT)
time frame: Screening, 12 months, and 24 months
description: Change in 6MWT from baseline to 12 and 24 months.
measure: Peripheral Artery Questionnaire (PAQ)
time frame: Screening, 1 month, 12 months, and 24 months
description: Change in PAQ score from baseline to 1, 12, and 24 months.
arm group label: Surmodics SurVeil DCB
arm group type: Experimental
description: Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.
arm group label: Medtronic IN.PACT Admiral DCB
arm group type: Active Comparator
description: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
intervention type: Device
intervention name: Surmodics SurVeil DCB
description: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
arm group label: Surmodics SurVeil DCB
intervention type: Device
intervention name: Medtronic IN.PACT Admiral DCB
description: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
arm group label: Medtronic IN.PACT Admiral DCB
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William Gray, MD
role: Principal Investigator
affiliation: Lankenau Heart Group
last name: Kenneth Rosenfield, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Marianne Brodmann, MD
role: Principal Investigator
affiliation: Medical University Graz, Department of Internal Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Austria
country: Belgium
country: Czechia
country: Germany
country: Italy
country: Latvia
country: New Zealand
country: United States
country: Singapore
country: Switzerland
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
citation: Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
PMID: 17140820
citation: Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. doi: 10.1016/j.jacc.2015.09.063. Epub 2015 Oct 14.
PMID: 26476467
citation: Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Muller-Hulsbeck S, Nehler MR, Benenati JF, Scheinert D; LEVANT 2 Investigators. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. 2015 Jul 9;373(2):145-53. doi: 10.1056/NEJMoa1406235. Epub 2015 Jun 24.
PMID: 26106946
citation: Patel MR, Conte MS, Cutlip DE, Dib N, Geraghty P, Gray W, Hiatt WR, Ho M, Ikeda K, Ikeno F, Jaff MR, Jones WS, Kawahara M, Lookstein RA, Mehran R, Misra S, Norgren L, Olin JW, Povsic TJ, Rosenfield K, Rundback J, Shamoun F, Tcheng J, Tsai TT, Suzuki Y, Vranckx P, Wiechmann BN, White CJ, Yokoi H, Krucoff MW. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015 Mar 10;65(9):931-41. doi: 10.1016/j.jacc.2014.12.036. Erratum In: J Am Coll Cardiol. 2015 Jun 16;65(23):2578-9.
PMID: 25744011
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Vascular Diseases
sharing ipd: No
submitted: August 23, 2023