A Prospective Study of Paclitaxel Drug-coated Balloon Angioplasty for Treating Symptomatic Peripheral Arterial Disease

What this Trial Is About

Researchers are collecting long-term safety and performance data on the VITUS peripheral drug-coated dilatation catheter in patients with peripheral arterial occlusive disease (PAOD). This observational registry includes patients undergoing balloon angioplasty with the device as part of routine care. About 284 patients from around 15 European centers will participate to provide real-world evidence on the treatment's effectiveness and safety. The treatment involves percutaneous transluminal angioplasty using a paclitaxel drug-coated balloon catheter. Patients receive the device according to the physician's decision and instructions for use. Lesions treated are generally shorter than the balloon length, with overlapping balloons allowed for longer lesions to ensure coverage. Follow-up is planned at multiple points: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, and 36 months. Participants will be monitored through telephone or hospital visits up to three years after the procedure. Researchers will assess major adverse events at 30 days and 12 months, freedom from target lesion revascularization, and clinical improvements like Rutherford classification changes and walking ability. Additional outcomes include amputation-free survival, device and procedure success, quality of life, and vessel patency. This comprehensive follow-up aims to better understand treatment outcomes in everyday clinical practice.

VITUS Post-Market Registry