The Esprit BTK Post-Approval Study (PAS) is looking at how safe and effective a medical device is for people with a condition called Chronic Limb-Threatening Ischemia (CLTI). This condition affects blood flow to the legs. The study involves using the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System, which is a special tube-like device that helps keep blood vessels open and releases medicine to prevent blockage. This study will take place at up to 50 locations in the United States, and possibly more outside the U.S., with about 200 participants.
- The study involves observing patients in a real-world setting, not giving them new or experimental treatments.
- Participants need to be at least 18 years old and have specific issues with their leg's blood vessels.
- People who have been treated with the Esprit BTK before or are in another study cannot participate.
Before joining, participants must agree in writing. The study will look at patients who have blood vessel issues in the lower leg, with certain criteria for size and blockage. If you're considering joining, it's important to know you will not be able to participate if your condition requires a metallic stent or if you have a very poor health outlook.