Study of Eight iVascular Devices for Endovascular Treatment in Renal, Iliac, and Femoral Arteries Evaluating Safety and Performance of Balloon Catheters, Drug Coated Balloons, Stent Systems, and Support Catheters

What this Trial Is About

This research aims to confirm and support 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 involves a real-world population of 209 patients who have undergone these procedures as part of standard care. The goal is to evaluate these devices in typical clinical settings to better understand their use and outcomes. Participants will undergo the same endovascular intervention procedure using one or more of the investigational devices from iVascular. These devices include the Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters, Luminor 18 and Luminor 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. The procedure and device use follow the instructions for use specific to each device. During the study, researchers will monitor patients from the time of procedure up to two years afterward. They will assess freedom from serious adverse events and device-related events as primary safety measures, along with the technical success of the procedure. Physicians will also provide ratings of the devices during the procedure. Follow-up includes an exploratory endpoint assessment up to two years post-procedure to understand longer-term outcomes and device performance.

Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries