xml: <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/NCT05971394</url>
    </required_header>
    <id_info>
      <org_study_id>BTK-01</org_study_id>
      <nct_id>NCT05971394</nct_id>
    </id_info>
    <brief_title>IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial</brief_title>
    <official_title>A Prospective, Multicentre, Single Arm Clinical Trial to Assess the Safety and Effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in Treating Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Biotyx Medical (Shenzhen) Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>VascuScience GmbH</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Mediolanum Cardio Research Srl</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Euroimage Research Srl</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Biotyx Medical (Shenzhen) Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this prospective, multicentre, single arm clinical trial is to assess the safety&#xD;
        and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS&#xD;
        Titan™) in treating patients with infrapopliteal arterial stenosis or occlusive disease. 100&#xD;
        participants will be implanted with IBS Titan™, and be followed up for 1-month, 6-month and&#xD;
        12-month after discharge.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 17, 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">January 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Freedom from Primary Efficacy Failure</measure>
      <time_frame>6 months</time_frame>
      <description>Defined as freedom from the composite of total occlusion of target lesion and clinically driven target lesion revascularization (CD-TLR), and freedom from major amputation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Major adverse event (MAE)</measure>
      <time_frame>1 month, 6 months, 12 months</time_frame>
      <description>Defined as a composite of all-cause mortality, CD-TLR and major amputation of target limb.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Device success</measure>
      <time_frame>Immediately post-procedure</time_frame>
      <description>Stent level analysis, based on single stent. Defined as the achievement of successful delivery, deployment of stent at the intended infrapopliteal target site(s) and successful withdrawal of the delivery catheter.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Technical success</measure>
      <time_frame>Immediately post-procedure</time_frame>
      <description>Defined as the restoration of blood flow in the target vessel and angiogram indicates the residual stenosis &lt;30%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Procedural success</measure>
      <time_frame>Immediately post-procedure</time_frame>
      <description>Defined as the combination of technical success, device success, and absence of procedural complications.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Target lesion restenosis</measure>
      <time_frame>1 month, 6 months, 12 months</time_frame>
      <description>Defined as peak systolic velocity ratio (PSVR) &gt;2.4 by DUS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ankle-brachial index (ABI) compared to baseline (before treatment)</measure>
      <time_frame>1 month, 6 months, 12 months</time_frame>
      <description>Change in Ankle Brachial Index (ABI) from pre-procedure. Larger values mean a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Rutherford Category compared to baseline (before treatment)</measure>
      <time_frame>1 month, 6 months, 12 months</time_frame>
      <description>Categories and Clinical Description (higher scores mean a worse outcome):&#xD;
  Category 0 = Asymptomatic, no hemodynamically significant occlusive disease, Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication, Category 4 = Ischemic rest pain, Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Infrapopliteal Lesions</condition>
    <condition>Critical Limb Ischemia</condition>
    <arm_group>
      <arm_group_label>IBS Titan</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects treated with IBS Titan™.Participants will be included in this arm.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)</intervention_name>
      <description>Subjects in this arm will be treated with Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)</description>
      <arm_group_label>IBS Titan</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • General criteria&#xD;
  &#xD;
            1. Subject between 18 and 85 years old.&#xD;
  &#xD;
            2. Subject who can understand the purpose of the trial, voluntarily participate in, and&#xD;
               sign the informed consent form, and who are willing to participate until the 12 months&#xD;
               follow-up.&#xD;
  &#xD;
            3. Subject has symptomatic Critical Limb Ischemia, Rutherford category 3-5.&#xD;
  &#xD;
            4. Subject requires primary treatment of de novo infrapopliteal lesions.&#xD;
  &#xD;
               • Angiographic criteria&#xD;
  &#xD;
            5. Target lesion stenosis ≥ 70% or occlusion in no more than two infrapopliteal arteries.&#xD;
  &#xD;
            6. The distal margin of the target lesion must be located ≥ 10 cm proximal to the&#xD;
               proximal margin of the ankle mortise.&#xD;
  &#xD;
            7. The target lesion must be located in the proximal 2/3 of native infrapopliteal&#xD;
               vessels, length is ≤ 200mm, with vessel diameter of 2.5-4 mm.&#xD;
  &#xD;
            8. Only two infrapopliteal vessels are allowed to be treated at the same time.&#xD;
  &#xD;
            9. A maximum of two stents can be deployed at one target vessel.&#xD;
  &#xD;
           10. There must be at least one unimpaired artery (&lt; 30% stenosis) to the ankle.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • General criteria：&#xD;
  &#xD;
            1. Severe renal insufficiency, hepatic dysfunction (Cr &gt; 2 times normal limit or renal&#xD;
               dialysis, ALT or AST &gt; 5 times normal limit).&#xD;
  &#xD;
            2. Major amputation before index procedure or plan for major amputation.&#xD;
  &#xD;
            3. Any coagulation disorder.&#xD;
  &#xD;
            4. Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity&#xD;
               in the past 6 weeks.&#xD;
  &#xD;
            5. Stroke within 3 months, or stroke with severe hemiplegia and aphasia sequelae more&#xD;
               than 3 months before inclusion in the study.&#xD;
  &#xD;
            6. Acute myocardial infarction or acute ischemia within 30 days before inclusion in the&#xD;
               study.&#xD;
  &#xD;
            7. Thromboangiitis obliterans (Buerger's disease).&#xD;
  &#xD;
            8. Any previous treatment with drug eluting balloon or drug eluting stent within 90 days&#xD;
               before inclusion.&#xD;
  &#xD;
            9. Any surgery in target vessel before index procedure.&#xD;
  &#xD;
           10. Volume reduction operation in target vessel before inclusion.&#xD;
  &#xD;
           11. Subject known to be allergic to aspirin, heparin, clopidogrel, Polylactic acid, iron,&#xD;
               zinc and its degradation products, contrast agents, sirolimus, etc., and those who&#xD;
               cannot tolerate postoperative dual anti-platelet therapy.&#xD;
  &#xD;
           12. Subject with a history of iron overload or iron disorders related diseases, such as&#xD;
               hereditary hemochromatosis, etc.&#xD;
  &#xD;
           13. Subject is currently participating in another clinical trial that has not yet&#xD;
               completed its primary endpoint.&#xD;
  &#xD;
           14. Women of child-bearing potential not using an effective contraception; pregnant or&#xD;
               lactating women.&#xD;
  &#xD;
           15. Subject is not suitable to participate in the trial as per investigators discretion.&#xD;
  &#xD;
           16. Life expectancy ≤ 12 months as per investigators judgement.&#xD;
  &#xD;
               • Angiographic criteria&#xD;
  &#xD;
           17. The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal&#xD;
               artery) has lumen stenosis &gt;30% with or without intervention.&#xD;
  &#xD;
           18. The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal&#xD;
               artery) has &gt; 150 mm stenosis or occlusion before treatment.&#xD;
  &#xD;
           19. Significant stenosis (≥50% stenosis) of the arterial outflow tract perfused by the&#xD;
               target vessel.&#xD;
  &#xD;
           20. In-stent restenosis in any lower extremity artery.&#xD;
  &#xD;
           21. Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and&#xD;
               thrombectomy.&#xD;
  &#xD;
           22. Guide wire cannot pass target lesion.&#xD;
  &#xD;
           23. Angiography suggests intraoperative thromboendarterectomy, percutaneous transluminal&#xD;
               rotational atherectomy or laser therapy are needed.&#xD;
  &#xD;
           24. Aneurysm of lower extremity artery in the ipsilateral leg.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ying Xia</last_name>
      <phone>0755 23221096</phone>
      <email>xiaying@lifetechmed.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Azienda Ospedaliero Universitaria Careggi</name>
        <address>
          <city>Florence</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Fabrizio Fanelli</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>BTK</keyword>
    <keyword>below-the-knee</keyword>
    <keyword>Infrapopliteal lesions</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sirolimus</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971394
  org study id: BTK-01
  nct id: NCT05971394
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective, multicentre, single arm clinical trial is to assess the safety
        and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS
        Titan™) in treating patients with infrapopliteal arterial stenosis or occlusive disease. 100
        participants will be implanted with IBS Titan™, and be followed up for 1-month, 6-month and
        12-month after discharge.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Freedom from Primary Efficacy Failure
  time frame: 6 months
  description: Defined as freedom from the composite of total occlusion of target lesion and clinically driven target lesion revascularization (CD-TLR), and freedom from major amputation.
  measure: Major adverse event (MAE)
  time frame: 1 month, 6 months, 12 months
  description: Defined as a composite of all-cause mortality, CD-TLR and major amputation of target limb.
  measure: Rate of Device success
  time frame: Immediately post-procedure
  description: Stent level analysis, based on single stent. Defined as the achievement of successful delivery, deployment of stent at the intended infrapopliteal target site(s) and successful withdrawal of the delivery catheter.
  measure: Rate of Technical success
  time frame: Immediately post-procedure
  description: Defined as the restoration of blood flow in the target vessel and angiogram indicates the residual stenosis <30%.
  measure: Rate of Procedural success
  time frame: Immediately post-procedure
  description: Defined as the combination of technical success, device success, and absence of procedural complications.
  measure: Incidence of Target lesion restenosis
  time frame: 1 month, 6 months, 12 months
  description: Defined as peak systolic velocity ratio (PSVR) >2.4 by DUS.
  measure: Change in ankle-brachial index (ABI) compared to baseline (before treatment)
  time frame: 1 month, 6 months, 12 months
  description: Change in Ankle Brachial Index (ABI) from pre-procedure. Larger values mean a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm.
  measure: Change in Rutherford Category compared to baseline (before treatment)
  time frame: 1 month, 6 months, 12 months
  description: Categories and Clinical Description (higher scores mean a worse outcome):
  Category 0 = Asymptomatic, no hemodynamically significant occlusive disease, Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication, Category 4 = Ischemic rest pain, Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
  arm group label: IBS Titan
  arm group type: Experimental
  description: Subjects treated with IBS Titan™.Participants will be included in this arm.
  intervention type: Device
  intervention name: Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
  description: Subjects in this arm will be treated with Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
  arm group label: IBS Titan
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Ying Xia
  phone: 0755 23221096
  email: xiaying@lifetechmed.com
  facility: 
  status: Recruiting
  investigator: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Chronic Limb-Threatening Ischemia
  mesh term: Ischemia
  mesh term: Sirolimus
  sharing ipd: Undecided