<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/NCT04475783</url>
  </required_header>
  <id_info>
    <org_study_id>ZKSJ0127</org_study_id>
    <secondary_id>DRKS00022452</secondary_id>
    <nct_id>NCT04475783</nct_id>
  </id_info>
  <brief_title>Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease</brief_title>
  <acronym>SIRONA</acronym>
  <official_title>Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jena University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Concept Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vascuscience</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CoreLab Black Forest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for Clinical Studies Jena</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jena University Hospital</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>
      This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority&#xD;
      trial.&#xD;
&#xD;
      The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated&#xD;
      balloon in comparison to the treatment with PTX drug-coated balloon (control device) in&#xD;
      patients with femoropopliteal artery disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in&#xD;
      the obstructed artery for several seconds to minutes, has become the standard endovascular&#xD;
      treatment for peripheral arteries. The long-term success of bare balloon PTA in the&#xD;
      fem-oropopliteal segment is hampered by the occurrence of restenosis, which can be reduced by&#xD;
      local antiproliferative drug delivery via the PTA balloon catheter.&#xD;
&#xD;
      The rationale of this study is based on the hypothesis that the usage of the Sirolimus-coated&#xD;
      Magic Touch Sirolimus DCB is at least equal (non-inferior) with regards to efficacy and&#xD;
      safety in comparison with a clinically well-established PTX coated balloon.&#xD;
&#xD;
      The objective of this prospective, randomized, multi-center, post-market study is to compare&#xD;
      the Magic Touch Sirolimus DCB with Paclitaxel-coated DCB for treatment of high grade&#xD;
      ste-notic or occluded lesions in SFA and / or P1 segment of the popliteal artery (PA) in PAD&#xD;
      pa-tients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 13, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>1:1-randomization, parallel design, stratified by Center.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patency rate (Absence of clinically driven target lesion revascularization)</measure>
    <time_frame>one year after study procedure (PTA with medical product under investigation or comparator)</time_frame>
    <description>patency rate after one year defined as absence of clinically driven target lesion revascularization (TLR) due to symptoms and drop of ABI of ≥ 20% or &gt; 0.15 when compared to post-procedure or restenosis with PVR &gt; 2.4 evaluated by duplex ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety outcome</measure>
    <time_frame>through 12 months post-procedure</time_frame>
    <description>Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel vessel revasculariza-tion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TLR rate</measure>
    <time_frame>1, 6, 12, 24, 36, 48 and 60 months after study procedure</time_frame>
    <description>ocurrence of Target lesion revascularization (TLR) at certain time Points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutherford classification</measure>
    <time_frame>at 12 months after study procedure</time_frame>
    <description>Sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking capacity assessment 1</measure>
    <time_frame>at 1, 6, 12, 24, 36, 48 and 60 months after study procedure</time_frame>
    <description>patient-self-assessment of walking distance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking capacity assessment 2</measure>
    <time_frame>at 6, 12, 24, 48 months after study procedure</time_frame>
    <description>6-minute Walking test (6MWT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking capacity assessment 3</measure>
    <time_frame>at 6, 12, 24, 48 months after study procedure</time_frame>
    <description>Treadmill test (optional)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking capacity assessment 4</measure>
    <time_frame>at 6, 12, 24, 48 months after study procedure</time_frame>
    <description>Walking Impairment Questionnaire (WIQ); 20 questions (scale 0 to 4); best score 0, worst score 80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duplex Ultrasound</measure>
    <time_frame>post-procedure and at 6, 12, 24 and 48 months or at any time of re-intervention</time_frame>
    <description>Duplex-defined binary restenosis (PSVR &gt;2.4) of the target lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ABI</measure>
    <time_frame>at discharge, 6, 12, 24 and 48 months</time_frame>
    <description>Ankle brachial index (ABI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualilty of Life Assessment</measure>
    <time_frame>at 1 month, 6, 12, 24, 36, 48 and 60 months</time_frame>
    <description>Quality of life assessment (QoL) by EQ5D-3L questionnaire; 5 questions (scale 1 to 5), best score 5, worst score 25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Safety: freedom from all cause death, target limb major amputation and clinically-driven target vessel revascularization</measure>
    <time_frame>trough 60 months after study procedure</time_frame>
    <description>Composite of freedom from all cause death through 60 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">478</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>Sirolomus DCB group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention with Sirolimus-coated balloon catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paclitaxel DCB group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention with Paclitaxel-coated balloon catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Percutaneous Transluminal Angioplasty (PTA)</intervention_name>
    <description>PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery</description>
    <arm_group_label>Paclitaxel DCB group</arm_group_label>
    <arm_group_label>Sirolomus DCB group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject age ≥ 18&#xD;
&#xD;
          2. Subject has been informed on the nature of the study, the duration of the study,&#xD;
             agrees to attend follow-up visits, agrees to complete the required testing, agrees to&#xD;
             participate, and has signed an informed consent form.&#xD;
&#xD;
          3. Rutherford category 2-4 according to the investigator's subjective evaluation&#xD;
&#xD;
          4. Subject has a de novo or re-stenosed lesion with ≥ 70 % stenosis documented&#xD;
             angiographically&#xD;
&#xD;
          5. Target lesion length is ≥ 2 cm and ≤ 20 cm by visual estimate of the treating&#xD;
             physician&#xD;
&#xD;
          6. Multiple lesions with max. 3 cm healthy vessel segment in between lesions can be&#xD;
             considered at the discretion of the operator as one lesion. Total lesion length should&#xD;
             not exceed 20 cm&#xD;
&#xD;
          7. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation&#xD;
&#xD;
          8. Patency of P2 and P3 segment of the popliteal artery and at least one (1)&#xD;
             infrapopliteal artery to the ankle (&lt; 50 % diameter stenosis) in continuity with the&#xD;
             femoropopliteal artery&#xD;
&#xD;
          9. Patency of ipsilateral iliac artery (≤ 30% diameter stenosis). Iliac artery stenosis &gt;&#xD;
             30 % may be treated during the index procedure to ensure sufficient inflow.&#xD;
&#xD;
         10. A guidewire has successfully traversed the target treatment segment intraluminal&#xD;
&#xD;
         11. Vascular disease in the opposite leg that requires treatment at the time point of&#xD;
             index procedure is allowed, but has to be treated according to randomization or with&#xD;
             POBA.&#xD;
&#xD;
         12. A patient can only be enrolled and randomized once with only one target lesion in the&#xD;
             SIRONA trial. Please note that only the lesion in one limb can be treated as target&#xD;
             lesion for index procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Failure to successfully cross the target lesion or subintimal target lesion guidewire&#xD;
             crossing&#xD;
&#xD;
          2. Flow-limiting dissection after pre-dilatation&#xD;
&#xD;
          3. Angiographic evidence of severe calcification of the target vessel (contiguous&#xD;
             calcification on both sides of the vessel)&#xD;
&#xD;
          4. Presence of fresh thrombus in the target lesion&#xD;
&#xD;
          5. Presence of aneurysm in the target vessel/s&#xD;
&#xD;
          6. Prior vascular surgery (including atherectomy, bypass surgery) of the target limb&#xD;
&#xD;
          7. Prior stent in the target lesion&#xD;
&#xD;
          8. Stroke or heart attack within 3 months prior to enrollment&#xD;
&#xD;
          9. Any vascular surgical procedure or intervention performed in the target limb within 30&#xD;
             days prior to or planned within 30 days post index procedure&#xD;
&#xD;
         10. Any vascular treatment with PTX or sirolimus-coated devices 60 days prior to index&#xD;
             procedure&#xD;
&#xD;
         11. Target lesion requires treatment with alternative therapies such as primary stenting,&#xD;
             laser, lithotripsy, thrombectomy, atherectomy, cryoplasty, brachytherapy, re-entry&#xD;
             devices&#xD;
&#xD;
         12. Enrolled in another investigational drug, device or biologic study&#xD;
&#xD;
         13. Life expectancy of less than one year in the investigator's opinion&#xD;
&#xD;
         14. Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet&#xD;
             therapies, sirolimus, paclitaxel or contrast media that cannot be adequately&#xD;
             pre-treated prior to index procedure&#xD;
&#xD;
         15. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate&#xD;
             the use of anti-platelet therapy&#xD;
&#xD;
         16. Receiving dialysis or immunosuppressant therapy&#xD;
&#xD;
         17. Pregnant or lactating females&#xD;
&#xD;
         18. History of major amputation in the same limb as the target lesion&#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>Ulf Teichgraeber, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital Jena, Institute of Radiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medizinische Universität Graz, Klinische Abteilung für Angiologie</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Klagenfurt am Wörthersee, Institut für Diagnostische und Interventionelle Radiologie</name>
      <address>
        <city>Klagenfurt</city>
        <zip>9020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Vienna, Universitätsklinik für Innere Medizin II, Klinische Abteilung für Angiologie</name>
      <address>
        <city>Vienna</city>
        <zip>A-1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik für Radiologie und Nuklearmedizin, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanusch-Krankenhaus</name>
      <address>
        <city>Wien</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Heart Center Freiburg-Bad Krozingen</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin, Klinik für Radiologie</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fürst-Stirum-Klinik Bruchsal, Klinik für Kardiologie, Angiologie, Diabetologie, Neurologie und Intensivmedizin</name>
      <address>
        <city>Bruchsal</city>
        <zip>76646</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Dresden, Institut und Poliklinik für Diagnostische und Interventionelle Radiologie</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen, Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DIAKO Krankenhaus gGmbH, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie</name>
      <address>
        <city>Flensburg</city>
        <zip>24939</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Radiologie</name>
      <address>
        <city>Halle (Saale)</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg, Medizinische Klinik III, Kardiologie, Angiologie und Pneumologie</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikverbund Allgäu gGmbH, Herz- und Gefäßzentrum Oberallgäu Kempten, Klinik Immenstadt</name>
      <address>
        <city>Immenstadt Im Allgäu</city>
        <zip>87509</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Jena</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios Klinikum Krefeld, Institut für Diagnostische und Interventionelle Radiologie</name>
      <address>
        <city>Krefeld</city>
        <zip>47805</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig, Klinik und Poliklinik für Angiologie</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marienhaus Klinikum Mainz, Klinik für Diagnostische und Interventionelle Radiologie</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gefäßpraxis im Tal</name>
      <address>
        <city>München</city>
        <zip>80331</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Franziskus-Hospital GmbH, Klinik für Gefäßchirurgie</name>
      <address>
        <city>Münster</city>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster, Klinik für Kardiologie I, Koronare Herzkrankheit, Herzinsuffizienz und Angiologie</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elblandklinikum Radebeul, Gefäßzentrum</name>
      <address>
        <city>Radebeul</city>
        <zip>01445</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imland Klinik Rendsburg, Institut für Diagnostische und Interventionelle Radiologie/Neuroradiologie</name>
      <address>
        <city>Rendsburg</city>
        <zip>24768</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RoMed Klinikum Rosenheim, Diagnostische und Interventionelle Radiologie</name>
      <address>
        <city>Rosenheim</city>
        <zip>83022</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MEDINOS-Kliniken Sonneberg, Gefäßzentrum</name>
      <address>
        <city>Sonneberg</city>
        <zip>96515</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kreiskrankenhaus Torgau, Abt. Innere Medizin / Angiologie</name>
      <address>
        <city>Torgau</city>
        <zip>04860</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jena University Hospital</investigator_affiliation>
    <investigator_full_name>Ulf Teichgräber</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Peripheral Artery Disease</keyword>
  <keyword>Sirolimus</keyword>
  <keyword>Paclitaxel</keyword>
  <keyword>Drug-Coated Balloon</keyword>
  <keyword>Percuteanous Transaluminal Angioplasty</keyword>
  <keyword>PPA</keyword>
  <keyword>SFA</keyword>
  <keyword>MagicTouch PTA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04475783
org study id: ZKSJ0127
secondary id: DRKS00022452
nct id: NCT04475783
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority
      trial.

      The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated
      balloon in comparison to the treatment with PTX drug-coated balloon (control device) in
      patients with femoropopliteal artery disease.
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. The long-term success of bare balloon PTA in the
      fem-oropopliteal segment is hampered by the occurrence of restenosis, which can be reduced by
      local antiproliferative drug delivery via the PTA balloon catheter.

      The rationale of this study is based on the hypothesis that the usage of the Sirolimus-coated
      Magic Touch Sirolimus DCB is at least equal (non-inferior) with regards to efficacy and
      safety in comparison with a clinically well-established PTX coated balloon.

      The objective of this prospective, randomized, multi-center, post-market study is to compare
      the Magic Touch Sirolimus DCB with Paclitaxel-coated DCB for treatment of high grade
      ste-notic or occluded lesions in SFA and / or P1 segment of the popliteal artery (PA) in PAD
      pa-tients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1:1-randomization, parallel design, stratified by Center.
primary purpose: Treatment
masking: None (Open Label)
measure: Patency rate (Absence of clinically driven target lesion revascularization)
time frame: one year after study procedure (PTA with medical product under investigation or comparator)
description: patency rate after one year defined as absence of clinically driven target lesion revascularization (TLR) due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure or restenosis with PVR > 2.4 evaluated by duplex ultrasound
measure: Safety outcome
time frame: through 12 months post-procedure
description: Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel vessel revasculariza-tion
measure: TLR rate
time frame: 1, 6, 12, 24, 36, 48 and 60 months after study procedure
description: ocurrence of Target lesion revascularization (TLR) at certain time Points
measure: Rutherford classification
time frame: at 12 months after study procedure
description: Sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients
measure: Walking capacity assessment 1
time frame: at 1, 6, 12, 24, 36, 48 and 60 months after study procedure
description: patient-self-assessment of walking distance
measure: Walking capacity assessment 2
time frame: at 6, 12, 24, 48 months after study procedure
description: 6-minute Walking test (6MWT)
measure: Walking capacity assessment 3
time frame: at 6, 12, 24, 48 months after study procedure
description: Treadmill test (optional)
measure: Walking capacity assessment 4
time frame: at 6, 12, 24, 48 months after study procedure
description: Walking Impairment Questionnaire (WIQ); 20 questions (scale 0 to 4); best score 0, worst score 80
measure: Duplex Ultrasound
time frame: post-procedure and at 6, 12, 24 and 48 months or at any time of re-intervention
description: Duplex-defined binary restenosis (PSVR >2.4) of the target lesion
measure: ABI
time frame: at discharge, 6, 12, 24 and 48 months
description: Ankle brachial index (ABI)
measure: Qualilty of Life Assessment
time frame: at 1 month, 6, 12, 24, 36, 48 and 60 months
description: Quality of life assessment (QoL) by EQ5D-3L questionnaire; 5 questions (scale 1 to 5), best score 5, worst score 25
measure: Secondary Safety: freedom from all cause death, target limb major amputation and clinically-driven target vessel revascularization
time frame: trough 60 months after study procedure
description: Composite of freedom from all cause death through 60 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
arm group label: Sirolomus DCB group
arm group type: Experimental
description: Intervention with Sirolimus-coated balloon catheter
arm group label: Paclitaxel DCB group
arm group type: Active Comparator
description: Intervention with Paclitaxel-coated balloon catheter
intervention type: Combination Product
intervention name: Percutaneous Transluminal Angioplasty (PTA)
description: PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery
arm group label: Paclitaxel DCB group
arm group label: Sirolomus DCB group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulf Teichgraeber, Prof. Dr.
role: Study Director
affiliation: University Hospital Jena, Institute of Radiology
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country: Austria
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Jena University Hospital
investigator full name: Ulf Teichgräber
investigator title: Prof. Dr.
mesh term: Peripheral Arterial Disease
sharing ipd: No