SELUTION4BTK
- Study HIC#:2000035989
- Last Updated:12/15/2025
The purpose of this study is to learn how safe and effective the SELUTION Sustained Limus Release (SLR)™ Drug-Eluting Balloon (DEB) is in treating patients with a severe form of peripheral arterial disease (PAD) called Chronic Limb Threatening Ischemia (CLTI). You were chosen as a possible participant in this study because your doctor believes that you have a narrowing of an artery below your knee. In patients with PAD and CLTI, blood vessels in the leg can sometimes narrow or close off, which limits the amount of blood flow in your leg and foot. When patients have narrowing of their blood vessels, doctors can insert a small balloon into the blood vessel and then inflate the balloon in the narrowed region to help open up the blood vessel and restore proper blood flow. Balloon catheter or balloon angioplasty procedures are routinely performed and are not experimental.
- Age18 years and older
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Fadi Al Daoud
- Phone Number: 1-203-785-4398
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
CLINICAL INCLUSION CRITERIA
1) Subject age is ≥ 18 years
3) Subject has documented Chronic Limb Threatening Ischemia CLTI and symptoms of > 2 weeks duration.
5) Female subjects only: If female, then subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure
CLINICAL EXCLUSION CRITERIA
- Subject has extensive tissue loss of the foot
- Subject has chronic kidney insufficiency (dialysis dependent) or has undergone renal transplantation or acute renal insufficiency
- Subject has had prior major amputation of the same extremity or planned major amputation of either leg.
- Subject has contraindication to antiplatelet therapy such as Aspirin and Plavix
- Subject has experienced disabling stroke or ST-segment elevation myocardial infarction (STEMI) within 3 months of index procedure.
- Subject has acute coronary syndrome (heart attack)
- Platelet count <100,000
- Subject has systemic infection (WBC > 12,000 and febrile).
- Subject is known to be immune compromised (e.g., Human Immunodeficiency Virus [HIV],
- Subject is receiving cancer treatment
- Subject is bedridden.
- Subject has a body mass index (BMI) < 18.
