Study of Early Vessel Recoil After Below-the-Knee Artery Treatment Using Spur Retrievable Scaffold and Drug-Coated Balloon in Patients with Advanced Limb Ischemia and High-Risk Conditions

What this Trial Is About

Chronic limb threatening ischemia CLTI is the most severe form of peripheral arterial disease PAD, causing symptoms like rest pain, non-healing wounds, or gangrene. This condition is especially serious for high-risk groups such as patients with diabetes or those on long-term hemodialysis, who face higher rates of amputation and death. The study focuses on evaluating acute vessel recoil after treating below-the-knee BTK arteries in these specific patient groups using a new device. The study evaluates the Spur Peripheral Retrievable Scaffold System combined with a drug-coated balloon DCB to treat BTK arteries in CLTI patients with diabetes or on chronic hemodialysis. The Spur device temporarily supports the artery and helps the drug penetrate better by creating channels in the vessel lining. Participants will receive this combined treatment, and vessel recoil will be assessed 15 minutes after the procedure using angiography. Participants will undergo assessments including angiographic evaluation of vessel recoil shortly after treatment and follow-up measures up to 12 months, such as monitoring for limb amputations, adverse events, vessel reopening, blood flow indexes, symptom severity, and wound healing scores. The study aims to track safety and effectiveness indicators over this period. Total participation lasts up to one year after the intervention.

Vessel Recoil in Specific CLTI Populations