The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Intervention: Drug Eluting Stent - Below the Knee; Standard PTA Control Arm
Intervention description: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm; The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately 201 subjects will be randomized in a 2:1 fashion for phase A RCT. Randomizations will be stratified by investigational center and lesion length with 2 subjects receiving the DES BTK for every 1 subject receiving treatment with standard PTA.
Masking: Single (Outcomes Assessor)
Masking description: A review of the wound assessment data will be completed by independent reviewer(s) who will be blinded to the randomized therapy.
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Single phased global, prospective, multicenter clinical trial designed to demonstrate a
      superior patency rate and acceptable safety in below the knee arteries with lesions treated
      with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is 18 years or older and has signed and dated the trial informed consent form
             (ICF)

          2. Subject is willing and able to comply with the trial testing, procedures and follow-up
             schedule

          3. Subject has chronic, symptomatic lower limb ischemia, determined by Rutherford
             categories 4 or 5 in the target limb, with wound(s) confined to toes/forefoot

          4. Subject is a male or non-pregnant female. If female of child-bearing potential, and if
             sexually active must be using, or agree to use, a medically-acceptable method of birth
             control as confirmed by the investigator

        Intra-procedure Inclusion Criteria:

          1. Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk,
             anterior tibial, posterior tibial and/or peroneal artery(ies).

          2. Target lesion(s) must be at least 4cm above the ankle joint

          3. A single target lesion per vessel, in up to 2 vessels, in a single limb

          4. Degree of stenosis ≥ 70% by visual angiographic assessment

          5. Reference vessel diameter is between 2.5 - 3.25mm for phase A RCT

          6. Total target lesion length (or series of lesion segments) to be treated is ≤ 70 mm for
             phase A RCT prior to the data monitoring committee's approval for stent overlap.
             (Note: Lesion segment(s) must be fully covered with one DES BTK stent, if randomized
             to stent)

          7. Total target lesion length (or series of lesion segments) to be treated is ≤ 140 mm
             for phase A RCT after the data monitoring committee's approval for stent overlap
             (Note: Lesion segment(s) must be fully covered with up to two DES BTK stents, if
             randomized to stent)

          8. Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the
             ankle joint)

          9. Target lesion(s) is located in an area that may be stented without blocking access to
             patent main branches

         10. Treatment of all above the knee inflow lesion(s) is successful prior to treatment of
             the target lesion

         11. Guidewire has successfully crossed the target lesion(s)

        Exclusion Criteria:

          1. Life expectancy ≤ 1year

          2. Stroke ≤ 90 days prior to the procedure date

          3. Prior or planned major amputation in the target limb

          4. Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass)

          5. Previously implanted stent in the target vessel(s)

          6. Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date

          7. Renal failure as measured by a GFR ≤ 30ml/min per 1.73m2, measured ≤ 30 days prior to
             the procedure date

          8. Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure
             date

          9. NYHA class IV heart failure

         10. Subject has symptomatic coronary artery disease (ie, unstable angina)

         11. History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date

         12. Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease,
             vasculitis)

         13. Subject is currently taking Canagliflozin

         14. Body Mass Index (BMI) <18

         15. Active septicemia or bacteremia

         16. Coagulation disorder, including hypercoagulability

         17. Contraindication to anticoagulation or antiplatelet therapy

         18. Known allergies to stent or stent components

         19. Known allergy to contrast media that cannot be adequately pre-medicated prior to the
             interventional procedure

         20. Known hypersensitivity to heparin

         21. Subject is on a high dose of steroids or is on immunosuppressive therapy

         22. Subject is currently participating, or plans to participate in, another
             investigational trial that may confound the results of this trial (unless written
             approval is received from the Boston Scientific study team)

        Intra-procedure Exclusion Criteria

          1. Angiographic evidence of intra-arterial acute/subacute thrombus or presence of
             atheroembolism

          2. Treatment required in > 2 target vessels (Note: a target lesion originating in one
             vessel and extending into another vessel is considered 1 target vessel)

          3. Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s),
             (eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy)

          4. Aneurysm is present in the target vessel(s)

          5. Extremely calcified lesions