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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Pre-procedure Inclusion Criteria
1. Subject is 18 years or older and has signed and dated the trial informed
consent form (ICF). Note: For subjects in Japan who are less than 20 years of
age, the subject*s legal representative must provide written informed consent
in addition to the subject
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).
• Target lesion(s) must be at least 4cm above the ankle joint
• A single target lesion per vessel, in up to 2 vessels, in a single limb
• Degree of stenosis >= 70% by visual angiographic assessment
• Reference vessel diameter (RVD) is between 2.5 - 3.25mm for phase A RCT
• Total target lesion length (or series of lesion segments) to be treated is <=
140mm for phase A RCT after DMC approval for stent overlap (Note: Lesion
segment(s) must be fully covered with up to two DES BTK stents, if randomized
to stent)
• Total target lesion length (or series of lesion segments) to be treated is <=
140mm for phase B non-randomized (Note: Lesion segment(s) must be fully covered
with up to two DES BTK stents)

2. Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm
above the ankle joint)
3. Target lesion(s) is located in an area that may be stented without blocking
access to patent main branches
4. Treatment of all above the knee inflow lesion(s) is successful prior to
treatment of the target lesion
5. Guidewire has successfully crossed the target lesion(s)

Exclusion Criteria

Pre-Procedure 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