Study ID: LIFE-BTK
This randomized, controlled clinical trial seeks to determine the safety and efficacy of the everolimus eluting ESPRIT™ BTK system for the treatment of critical limb ischemia, a severe blockage in a leg artery that markedly reduces the patient’s blood flow. The ESPRIT BTK system (Abbott Medical Devices) is a fully resorbable device to treat blocked arteries below the knees in people battling advanced stages of peripheral artery disease.
Eligible participants are randomized into two study groups:
- Arm 1 patients receive the ESPRIT™ BTK system
- Arm 2 patients receive percutaneous transluminal angioplasty (balloon catheter)
This trial is evaluating the ESPRIT BTK™ Everolimus Eluting Bioresorbable Scaffold system for planned treatment of narrowed arterial infrapopliteal lesions causing critical limb ischemia to improve luminal diameter. The primary outcomes being measured include composite limb salvage and primary patency and freedom from major adverse events and perioperative death.
Eligible participants are those with symptomatic critical limb ischemia, Rutherford category 4 or 5, requiring treatment of up to two de novo or restenotic infrapopliteal lesions, and vessel diameter of >2.5mm to <3.75mm, and total lesion length up to 100 mm.
- Must have been diagnosed with symptomatic critical limb ischemia (Rutherford category 4 or 5)
- Female subjects must not be pregnant and must be on birth control so as not to become pregnant while on the trial