Study to Evaluate Safety and Performance of the Oscar Peripheral Catheter for Treating Lesions in Femoral, Popliteal, and Infrapopliteal Arteries

What this Trial Is About

Researchers are evaluating the safety and clinical performance of the Oscar Peripheral Multifunctional Catheter in patients with peripheral arterial disease affecting the femoral, popliteal, and infrapopliteal arteries. This prospective, multicenter, observational study aims to confirm procedural success and monitor in-hospital complications such as vessel perforation, rupture, acute occlusion, and distal embolization. The study includes patients with significant artery narrowing and specific lesion characteristics, who require endovascular intervention. The study uses the Oscar Peripheral Multifunctional Catheter, which includes three components the Oscar Support Catheter with integrated Lock Grip, the Oscar Dilator, and the Oscar PTA Balloon. The device is used to dilate lesions in the target arteries. The study focuses on procedural outcomes such as successful crossing of the target lesion, residual stenosis after vessel preparation, and absence of procedural complications. Treatments of inflow lesions may be performed before the target lesion treatment according to local standards. Participants will undergo the index procedure where procedural success and complications are closely monitored. Assessments include measuring procedural success rates, rates of adverse device effects, distal embolization, vessel rupture, perforation, and acute occlusion, as well as flow-limiting dissections and amputation occurrences within 30 days. Data on residual stenosis and crossing success will be collected. The study period extends until January 2026, with follow-up evaluations up to 30 days after discharge.

Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)