SELUTION 4 BTK

Clinical Trial Title 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 CLTI

National Clinical Trial Number: NCT05055297

Clinical Trial Protocol Description:

This study aims to demonstrate efficacy and 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 patients with chronic limb threatening ischemia (CLTI). This study is randomized 1:1 with intervention and control standard of care group. Patients will be followed for approximately 3 years.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

Have chronic limb-threatening ischemia with Rutherford classification category 4 or 5 and symptoms of > 2 weeks duration.

You will be excluded from the study if any of the following criteria apply to you:

Have had prior major amputation on the same side as the target limb or planned major amputation of either leg.
Are receiving (or scheduled to receive) cancer treatment with surgery or chemotherapy or radiation therapy.
Have presence of acute or chronic renal disease.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.