Study of Arcevo LSA Device for Treating Aortic Arch Aneurysms and Dissections Through Open Surgery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Arcevo LSA Hybrid Stent Graft System in patients with acute or chronic aortic dissection andor aneurysm involving the aortic arch and the descending thoracic aorta, with or without ascending aorta involvement. This prospective, multi-center clinical study aims to treat these complex aortic conditions using a device implanted during an open surgical procedure called total arch replacement. The study includes patients with different stages of aortic disease, including a primary arm for aneurysm or chronic dissection and a secondary arm for acute or subacute dissection. The Arcevo LSA device is an implantable aortic stent graft with a left subclavian artery LSA branch, delivered via a surgical graft system during open repair. If needed, additional coverage with a thoracic endovascular aortic repair TEVAR device may be used according to protocol. Patients undergo surgery within 90 days of consent, and anatomical criteria such as aortic diameters and vessel angles are used to determine suitability. The study is non-randomized and does not use placebo or masking. Participants are monitored for major adverse events, mortality, additional aortic procedures, device-related events, and radiographic findings at multiple follow-up points up to 60 months after the procedure. The primary outcome is the composite rate of patients free from one or more major adverse events one year after the procedure. Follow-up visits occur at 30 days, 6, 12, 24, 36, 48, and 60 months to assess safety and effectiveness. Participants adherence to follow-up and their overall health status are closely observed throughout the study.

Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA