Carpentras

Researchers are evaluating the safety and clinical performance of eight different iVascular devices used for endovascular interventions in patients with artery disease affecting the renal, iliac, or femoral arteries. The study includes 209 patients who have undergone these procedures as part of standard care. The goal is to confirm how well these devices work and how safe they are in a real-world setting. The treatments studied involve endovascular interventions using various investigational products from iVascular, such as the Oceanus 18 and 35 Balloon Dilatation Catheters, Luminor 18 and 35 Drug Coated Balloons, Restorer Peripheral Stent System, iVolution Pro Peripheral Self-Expanding Stent System, iCover Covered Peripheral Stent System, and Sergeant Peripheral Support Catheter. These devices are used according to their instructions for use to treat lesions in the renal, iliac, or femoral arteries. Participants are monitored during the procedure and followed for up to two years afterward. Researchers assess the primary safety outcome by tracking serious adverse events and device-related serious adverse events during and after the procedure. They also measure technical success during the procedure. The study involves obtaining informed consent, ensuring appropriate patient eligibility, and monitoring outcomes related to safety and device performance over time.