CERAB - Prospective, Non-Randomised Clinical Trial to Investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System Treating Aortic-iliac Occlusive Disease With CERAB

What this Trial Is About

Researchers are evaluating the safety and performance of the BeGraft Aortic balloon expandable covered Stent Graft System and the BeGraft Peripheral balloon expandable covered Stent Graft System in treating extensive aorto-iliac occlusive disease. This prospective, multi-center study focuses on using these devices in Covered Endovascular Reconstruction of Aortic Bifurcation CERAB procedures to treat this condition. The study aims to assess how well these stent graft systems work and their safety when implanted as covered stents in the affected arteries. The study involves using the BeGraft Aortic and BeGraft Peripheral covered stent graft systems during CERAB, a minimally invasive technique that rebuilds diseased aortic bifurcation and iliac arteries. These stents are introduced through arteries in the groin or arm to restore blood flow. The procedure uses up to three peripheral stents per limb and targets lesions with significant narrowing or blockage. The devices are evaluated without the need for chimney techniques, and specific sizing and placement criteria apply. Participants will undergo follow-up visits to assess outcomes such as freedom from needing additional treatment at 12 months and incidence of serious device-related adverse effects. Other evaluations include technical success, vessel patency, need for surgical conversion, patient-reported outcomes, clinical success, hemodynamic improvements, and safety monitored at various intervals up to 24 months. Participants must provide consent and attend scheduled follow-ups to track the stents performance and safety over time.

Prospective, Non-Randomised Clinical Trial to Investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System Treating Aortic-iliac Occlusive Disease