Real-world Outcomes of Shockwave Intravascular Lithotripsy IVL in Treating Calcified Common Femoral Artery Lesions in Peripheral Artery Disease Patients

What this Trial Is About

This research aims to evaluate the outcomes of using Shockwave Intravascular Lithotripsy IVL technology in patients with peripheral artery disease who have calcified common femoral artery lesions. The study focuses on measuring health status improvements and treatment effectiveness in routine clinical practice, as well as gathering preliminary data for future comparative research. It also investigates procedural success and disease progression in these patients. Eligible patients with atherosclerotic femoral artery lesions causing claudication or critical limb ischemia will receive endovascular treatment including the use of Shockwave IVL technology. This device-based treatment is followed by standard care, which may include drug-coated balloons or stents, at the physicians discretion. The study observes outcomes immediately after the procedure and over a long-term follow-up period. Participants will be monitored through health status assessments at baseline, 30 days, 6 months, and up to 12 months. Researchers will track procedural success, target lesion revascularization rates, adverse events, and clinical improvements. Data collection includes patient evaluations during admission and follow-ups to understand the safety and effectiveness of IVL treatment in real-world clinical settings. Total participation duration can extend up to 12 months.

CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions