M.A. Med Alliance S.A.
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.
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…
a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia
a non-surgical procedure that uses a catheter to inflate a commercially available, non-drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia