Last updated on June 2019

The DES BTK Vascular Stent System vs PTA 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
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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
  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 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 using the assigned/randomized therapy
  4. Degree of stenosis 70% by visual angiographic assessment
  5. Reference vessel diameter is between 2.5 - 3.75mm
  6. Total target lesion length to be treated is 70mm for phase A RCT prior to the data monitoring committee's approval for stent overlap
  7. Total target lesion length to be treated is 140 mm for phase A RCT after the data monitoring committee's approval for stent overlap
  8. Total target lesion length to be treated is 140 mm for phase B non-randomized
  9. Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the ankle joint)
  10. Target lesion is located in an area that may be stented without blocking access to patent main branches
  11. Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion
  12. Guidewire has successfully crossed the target lesion

Exclusion Criteria:

  1. Life expectancy 1year
  2. Stroke 90 days prior to date the subject signed the ICF
  3. Prior or planned major amputation in the target limb
  4. Previous surgery in the target vessel (including prior ipsilateral crural bypass)
  5. Previously implanted stent in the target vessel(s) to be treated
  6. Failed PTA of target lesion/vessel 60 days prior to date the subject signed the ICF
  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/L less than or equal to 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 date the subject signed the ICF
  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 requires the use of alternate therapy in the target vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy)
  3. Aneurysm is present in the target vessel(s)
  4. Extremely calcified lesions

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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