A Randomized Trial comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Critical Limb Ischemia
    Peripheral Artery Disease
  • Age: Between 18 years - 101 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    Pre-Procedure Inclusion Criteria
    1. Subject is 18 years or older and has signed and dated the 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
    4. Subject is a male or non-pregnant female.
    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 must be at least 4cm above the ankle joint
    3. Degree of stenosis greater than or equal to 70%
    4. Reference vessel diameter is between 2.5mm - 3.75mm
    5. Target lesion is located in an area that may be stented without blocking access to patent main branches
    6. Treatment of all above the knee inflow lesion(s) is successful prior to treatment of target lesion

You may not be eligible for this study if the following are true:

  • Pre-procedure Exclusion Criteria
    1. Subject's life expectancy is less than or equal to 1year
    2. Subject had stroke less than or equal to 90 days prior to signing the consent
    3. Subjects had prior or planned major amputation in target limb
    4. Subjects had Previous surgery in the target vessel
    5. Subjects had Previously implanted stent in the target vessel(s) to be treated
    6. Subjects had Failed PTA of target lesion/vessel less than or equal to 60 days prior to signing the ICF
    7. Subjects with renal failure
    8. Subject has a platelet count between 50 and 600 X 103/microliters less than or equal to 30 days prior to the procedure date
    9. Subjects with heart failure
    10. Subject has symptomatic coronary artery disease
    11. Subjects had history of myocardial infarction or thrombolysis less than or equal to 90 days prior to signing the ICF
    12. Subjects have non-atherosclerotic disease resulting in occlusion
    13. Subject is currently taking Canagliflozin
    14. Body Mass Index (BMI) is less than 18
    15. Subjects have active septicemia or bacteremia
    16. Subjects have coagulation disorde
    17. Subjects have contraindication to anticoagulation or antiplatelet therapy
    18. Subjects have known allergies to stent or stent components
    19. Subjects have known allergy to contrast media that cannot be pre-medicated prior to interventional procedure
    20. Subjects have 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
    Intra-procedure Exclusion Criteria
    1. Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism
    2. Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s)
    3. Aneurysm is present in the target vessel(s)
    4. Extremely calcified lesions

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