Real-World Study of the Rotarex Rotational Excisional Atherectomy System for Treating Peripheral Arterial Disease

What this Trial Is About

Researchers are evaluating the use of the RotarexTM Rotational Excisional Atherectomy System in people treated for Peripheral Arterial Disease PAD. This prospective, single-arm, multicenter registry study aims to observe real-world clinical outcomes of this device in treating lesions in infra-inguinal peripheral arteries. Approximately 600 subjects will be recruited to better understand the devices procedural success and safety profile. Participants will receive treatment using the RotarexTM Rotational Excisional Atherectomy System according to the devices instructions for use. The study includes patients with specific stages of chronic and acute limb ischemia Rutherford classifications 2-5 for chronic and I to IIb for acute. The target lesion must be accessible by guidewire and suitable for treatment with this device. The study is single-arm, meaning all enrolled participants will receive this intervention without comparison to other treatments. During the study, participants will be monitored for procedural success immediately after treatment and followed for 30 days post-procedure to assess freedom from major complications. Subjects must comply with follow-up visits and procedures as part of the study. Researchers will collect data on the treatment outcomes and safety to evaluate the real-world use of the RotarexTM device. The total duration of participation varies depending on individual follow-up requirements.

Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)