Evaluating Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Treating Blockages in the Common and External Iliac Arteries

What this Trial Is About

Researchers are evaluating the Peripheral Balloon-Expandable Covered Stent System for treating narrowing or blockage stenosis or occlusion in the common and external iliac arteries, which are major blood vessels in the pelvis. This multi-center, prospective, single-arm clinical trial aims to assess the safety and effectiveness of this stent system by comparing results to pre-set performance goals. Participants include adults aged 18 to 80 years diagnosed with this vascular condition. The study involves implanting the balloon-expandable, covered stent into the affected iliac arteries to open the blood flow. After the procedure, participants will have follow-up visits at hospital discharge and then at 1, 6, 12, 24, and 36 months to monitor the stents function and safety. The trial does not include a comparison group and focuses on this single treatment method throughout the study period. During the follow-up visits, researchers will assess primary patency at 12 months, which measures whether the stent remains open, and will monitor for major adverse events over 36 months. Secondary patency will also be checked at 6, 12, 24, and 36 months. Participants will undergo clinical evaluations to track outcomes and any complications related to the stent system. The total participation lasts up to three years after the initial procedure.

Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)