<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/NCT03776799</url>
  </required_header>
  <id_info>
    <org_study_id>CIP_18/001</org_study_id>
    <nct_id>NCT03776799</nct_id>
  </id_info>
  <brief_title>BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery</brief_title>
  <official_title>BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery Comparing a Stent-avoiding (Study Arm) Versus Stent-preferred (Control Arm) Approach Within a Prospective, Randomized, Multi-center Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leipzig</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Leipzig</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, multi-center 1:1 randomized trial to compare efficacy and safety of a&#xD;
      stent-avoiding (using drug coated balloons) versus a stent-preferred (using drug eluting or&#xD;
      interwoven stents) approach for treatment of complex femoropopliteal lesions TASC II&#xD;
      (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease)&#xD;
      Type B-D (stenosis &gt;10cm, occlusions &gt;5cm).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, multi-center 1:1 randomized Study.&#xD;
&#xD;
      Patients will be stratified according to a stent-avoiding (study arm) or stent-preferred&#xD;
      (control arm)&#xD;
&#xD;
      In total 120 patient will be enrolled in this study, each strata will include 60 patients.&#xD;
&#xD;
      All enrolled patients will be followed up for 24 month to asses the incidence of restenosis&#xD;
      by duplex ultrasound and major adverse events.&#xD;
&#xD;
      Follow-up visits occur at 6, 12 and 24 month intervals as well as telephone visit after 1,36,&#xD;
      48 and 60 month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">July 2026</completion_date>
  <primary_completion_date type="Actual">August 24, 2022</primary_completion_date>
  <phase>N/A</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>Primary patency - Absence of clinically-driven target lesion revascularization (CD-TLR) and/or restenosis defined as a peak systolic velocity ratio (PSVR) &gt; 2.4 assessed by ultrasound</measure>
    <time_frame>1 Year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Walking capacity - Walking capacity assessed by Walking impairment questionnaire score at 6, 12 and 24</measure>
    <time_frame>2 Year</time_frame>
    <description>The graded score is multiplied by a pre-specified weight for each distance, speed, or number of stair flights. The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficult with any of the tasks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle-brachial index - Clinical improvment assessed by Ankle-brachial index at 6, 12 and 24 month</measure>
    <time_frame>2 Year</time_frame>
    <description>The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. An ABI between and including 0.9 and 1.2 considered normal (free from significant PAD), while a lesser than 0.9 indicates arterial disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutherford category - Clinical improvment assessed by Rutherford category at 6, 12 and 24 month</measure>
    <time_frame>2 Year</time_frame>
    <description>This classification system consists of four grades and seven categories (categories 0-6):&#xD;
Grade 0, Category 0: asymptomatic Grade I, Category 1: mild claudication Grade I, Category 2: moderate claudication Grade I, Category 3: severe claudication Grade II, Category 4: rest pain Grade III, Category 5: minor tissue loss; ischemic ulceration not exceeding ulcer of the digits of the foot Grade IV, Category 6: major tissue loss; severe ischemic ulcers or frank gangrene</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from device and procedure-related death, all-cause death, target limb major amputation and clinically-driven target lesion revascularization</measure>
    <time_frame>5 Years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Stent-avoiding approach</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>using clinically proven drug coated balloons</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stent-based approach</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>using drug eluting nitinol stents. Interwoven nitinol stents in heavily calcified lesions at the operator's discretion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stent-avoiding</intervention_name>
    <description>Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries</description>
    <arm_group_label>Stent-avoiding approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stent-based</intervention_name>
    <description>Stenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries</description>
    <arm_group_label>Stent-based approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject age ≥ 18&#xD;
&#xD;
          2. Subject has been informed of the nature of the study, agrees to participate, and has&#xD;
             signed a Medical Ethics Committee approved consent form Subject understands the&#xD;
             duration of the study, agrees to attend follow-up visits, and agrees to complete the&#xD;
             required testing.&#xD;
&#xD;
          3. Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented&#xD;
             angiographically and no prior stent in the target lesion.&#xD;
&#xD;
          4. Rutherford Becker Classification 2-4&#xD;
&#xD;
          5. Both treatment options seem feasible at the operator's discretion&#xD;
&#xD;
          6. Femoropopliteal lesions classified as TASC II Type B-D with a maximum lesion length ≤&#xD;
             30cm not involving the infrageniculate popliteal artery are eligible.&#xD;
&#xD;
          7. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.&#xD;
&#xD;
          8. Patency of at least one (1) infrapopliteal artery to the ankle (&lt; 50% diameter&#xD;
             stenosis) in continuity with the native femoropopliteal artery. The inflow artery(ies)&#xD;
             cannot be treated using a drug eluting stent or drug coated balloon&#xD;
&#xD;
          9. A guidewire has successfully traversed the target treatment segment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Failure to successfully cross the target lesion&#xD;
&#xD;
          2. Angiographic evidence of severe calcification that makes a stent-avoiding approach not&#xD;
             feasible at the operator's discretion.&#xD;
&#xD;
          3. Femoropopliteal lesions classified as TASC II Typ A (single stenosis &gt;=10cm and single&#xD;
             occlusion &gt;=5cm)&#xD;
&#xD;
          4. Presence of fresh thrombus in the lesion.&#xD;
&#xD;
          5. Presence of aneurysm in the target vessel/s&#xD;
&#xD;
          6. Presence of a stent in the target lesion&#xD;
&#xD;
          7. Prior vascular surgery of the target lesion.&#xD;
&#xD;
          8. Stroke or heart attack within 3 months prior to enrollment&#xD;
&#xD;
          9. Any planned surgical procedure or intervention performed within 30 days prior to or&#xD;
             post index procedure&#xD;
&#xD;
         10. SFA or PPA disease in the opposite leg that requires treatment at the index procedure&#xD;
&#xD;
         11. Enrolled in another investigational drug, device or biologic study that interferes&#xD;
             with the study&#xD;
&#xD;
         12. Life expectancy of less than one year&#xD;
&#xD;
         13. Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet&#xD;
             therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to&#xD;
             index procedure&#xD;
&#xD;
         14. Rutherford classification of 0, 1, 5 or 6.&#xD;
&#xD;
         15. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate&#xD;
             the use of anti-platelet therapy.&#xD;
&#xD;
         16. Platelet count &lt;100,000 mm3 or &gt;600,000 mm3&#xD;
&#xD;
         17. Receiving dialysis or immunosuppressant therapy&#xD;
&#xD;
         18. Pregnant or lactating females.&#xD;
&#xD;
         19. History of major amputation in the same limb as the target lesion&#xD;
&#xD;
         20. Chronic kidney disease (serum creatinine &gt; 3 mg/dL)&#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>Dierk Scheinert, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Clinic Leipzig</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Clinic Leipzig</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>November 21, 2022</last_update_submitted>
  <last_update_submitted_qc>November 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leipzig</investigator_affiliation>
    <investigator_full_name>Dierk Scheinert</investigator_full_name>
    <investigator_title>Clinic director</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03776799
org study id: CIP_18/001
nct id: NCT03776799
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prospective, multi-center 1:1 randomized trial to compare efficacy and safety of a
      stent-avoiding (using drug coated balloons) versus a stent-preferred (using drug eluting or
      interwoven stents) approach for treatment of complex femoropopliteal lesions TASC II
      (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease)
      Type B-D (stenosis >10cm, occlusions >5cm).
Prospective, multi-center 1:1 randomized Study.

      Patients will be stratified according to a stent-avoiding (study arm) or stent-preferred
      (control arm)

      In total 120 patient will be enrolled in this study, each strata will include 60 patients.

      All enrolled patients will be followed up for 24 month to asses the incidence of restenosis
      by duplex ultrasound and major adverse events.

      Follow-up visits occur at 6, 12 and 24 month intervals as well as telephone visit after 1,36,
      48 and 60 month.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary patency - Absence of clinically-driven target lesion revascularization (CD-TLR) and/or restenosis defined as a peak systolic velocity ratio (PSVR) > 2.4 assessed by ultrasound
time frame: 1 Year
measure: Walking capacity - Walking capacity assessed by Walking impairment questionnaire score at 6, 12 and 24
time frame: 2 Year
description: The graded score is multiplied by a pre-specified weight for each distance, speed, or number of stair flights. The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficult with any of the tasks)
measure: Ankle-brachial index - Clinical improvment assessed by Ankle-brachial index at 6, 12 and 24 month
time frame: 2 Year
description: The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. An ABI between and including 0.9 and 1.2 considered normal (free from significant PAD), while a lesser than 0.9 indicates arterial disease
measure: Rutherford category - Clinical improvment assessed by Rutherford category at 6, 12 and 24 month
time frame: 2 Year
description: This classification system consists of four grades and seven categories (categories 0-6):
Grade 0, Category 0: asymptomatic Grade I, Category 1: mild claudication Grade I, Category 2: moderate claudication Grade I, Category 3: severe claudication Grade II, Category 4: rest pain Grade III, Category 5: minor tissue loss; ischemic ulceration not exceeding ulcer of the digits of the foot Grade IV, Category 6: major tissue loss; severe ischemic ulcers or frank gangrene
measure: Freedom from device and procedure-related death, all-cause death, target limb major amputation and clinically-driven target lesion revascularization
time frame: 5 Years
arm group label: Stent-avoiding approach
arm group type: Other
description: using clinically proven drug coated balloons
arm group label: Stent-based approach
arm group type: Other
description: using drug eluting nitinol stents. Interwoven nitinol stents in heavily calcified lesions at the operator's discretion.
intervention type: Device
intervention name: Stent-avoiding
description: Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
arm group label: Stent-avoiding approach
intervention type: Device
intervention name: Stent-based
description: Stenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries
arm group label: Stent-based approach
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dierk Scheinert, Prof. Dr.
role: Principal Investigator
affiliation: University Clinic Leipzig
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Leipzig
investigator full name: Dierk Scheinert
investigator title: Clinic director
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: Undecided