Study to Compare the Safety and Effectiveness of the SELUTION SLR 014 Drug Eluting Balloon Versus Plain Balloon Angioplasty for Treating Below-the-Knee Peripheral Arterial Disease in Patients With Chronic Limb Threatening Ischemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the SELUTION SLR14 Drug Eluting Balloon DEB compared to plain uncoated balloon angioplasty in patients with peripheral arterial disease PAD affecting the below-the-knee BTK arteries, specifically in those with chronic limb-threatening ischemia CLTI. The study aims to show that the SELUTION SLR14 DEB has better efficacy and similar safety compared to the uncoated balloon treatment. Participants are adults aged 18 years or older with documented CLTI and significant narrowing in BTK arteries. The trial randomly assigns participants to one of two groups one receiving the SELUTION SLR14 DEB and the other receiving plain balloon angioplasty. Both are non-surgical procedures where a catheter inflates a balloon to open narrowed arteries below the knee. Treatments target specific lesions in BTK arteries and must meet detailed angiographic criteria. The study uses a single-blind design and includes follow-up assessments over several years. Participants will undergo evaluations at multiple time points including 30 days, 6 months, and up to 36 months after treatment. Assessments include clinical improvement, amputation rates, wound healing, imaging, and quality of life measures. Safety endpoints are monitored early, while efficacy outcomes are tracked long term. The study also evaluates device and procedural success immediately after treatment. Overall participation may last over three years to gather comprehensive safety and effectiveness data.

SELUTION4BTK Trial