SELUTION SLR™ 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chronic Limb Threatening Ischemia (CLTI)
M.A. Med Alliance S.A.
Summary
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Clinical Inclusion Criteria: 1. Subject age is ≥ 18 years or older depending on local regulations. 2. Subject life expectancy is ≥ 1 year. 3. Subject has documented chronic limb-threatening ischemia in the target limb with Rutherford classification category 4 or 5 and symptoms of \> 2 weeks duration. 4. Subject is willing and able to provide written informed consent and comply with study procedures and required follow-up evaluations. 5. Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure. Angiographic Inclusion…