Assessment of the Utility of the Pantheris SV System for Peripheral Arterial Disease in Below-Knee Arteries

What this Trial Is About

The trial investigates the use of the Pantheris Small Vessel (SV) system, an optical coherence tomography (OCT)-guided directional atherectomy catheter, for treating peripheral artery disease in arteries below the knee. This post-market, single-arm study aims to assess the device's utility by measuring arterial narrowing before and after atherectomy and tracking symptoms and adverse events over time. The study focuses on restoring blood flow and monitoring safety through adverse event reporting during and after the procedure. Participants will receive directional atherectomy using the Pantheris SV catheter on affected lower leg arteries, followed by additional therapy if deemed necessary by their physician. This single-arm approach means all participants receive the same treatment without comparison groups. The study includes follow-up assessments at 30 days, 6 months, and 1 year after the procedure to evaluate treatment success and symptom changes. During the study, participants will be evaluated through measures such as major adverse events from the procedure to 30 days post-procedure, technical and procedural success one day after treatment, and longer-term outcomes like vessel patency, freedom from revascularization, ankle-brachial index, and Rutherford classification at specified intervals. Data collection involves monitoring symptoms, adverse events, and blood flow restoration, with safety endpoints assessed immediately and within 30 days post-treatment. The total follow-up period extends to one year.

Assessment of the Utility of the Pantheris Small Vessel (SV) System