Real-World Study of Shockwave Balloon Treatment for Moderate-to-Severe Calcified Lesions in Femoral and Popliteal Arteries

What this Trial Is About

Researchers are investigating the use of shockwave balloons to treat moderate-to-severe calcification in the femoropopliteal artery, a condition common among patients with peripheral artery disease PAD and associated with diabetes or chronic kidney disease. This study aims to assess the real-world effectiveness of shockwave balloons in managing calcified lesions, building on previous trials that showed promising results but lacked extensive real-world data. The study evaluates the Shockwave intravascular lithotripsy IVL catheter system, which is designed to break down calcified structures in arteries while minimizing damage to the vessel lining. The device is used during angioplasty procedures to improve artery opening. Patients with moderate-to-severe calcification confirmed by imaging will be treated, and the study collects data on outcomes such as procedural success, patency rates, need for additional stenting, and safety over a follow-up period extending up to 12 months. Participants will undergo assessments including imaging to confirm lesion severity and arterial flow, along with clinical evaluations over several months after treatment to monitor improvement and adverse events. Researchers will track the quality of life related to vascular health and the rate of revascularization procedures at multiple timepoints. The study is observational, focusing on data collection from real-world use of the shockwave balloon technology, with participation lasting at least one year for outcome follow-up.

Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions