Post-Market Follow-up Study of JOTEC Vascular Grafts for Arterial Disease Treatment including Aortic and Peripheral Artery Conditions and AV Shunts

What this Trial Is About

This research investigates the safety and performance of various Vascular Grafts, including FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore, and FlowLine Bipore Heparin, in treating arterial diseases such as dissection, aneurysm, intramural hematoma, penetrating aortic ulcer, contained rupture, and stenosis affecting the aorta or peripheral arteries in the lower limbs. It also covers the use of these grafts for debranching head vessels and as arterio-venous shunts. The study is observational and focuses on patients who have already received these grafts. Patients included in this study have received one of these Vascular Grafts as part of their treatment for arterial conditions. The study collects data from routine care, including interventions like open repair of the aorta and peripheral arteries. The data collection period lasts approximately 60 months plus an additional 6 months beyond the last follow-up visit, depending on each patients timeline. Participants medical records and observations gathered during standard care visits will be used for data collection. Researchers will monitor outcomes such as 30-day mortality, longer-term mortality at intervals up to 60 months, graft-related adverse events, hemorrhage, stenosis or occlusion, graft patency, pseudoaneurysm formation, infections, sepsis, and stroke occurrences. Patients will be observed throughout this period while continuing their usual care, providing a comprehensive view of graft performance and safety over time.

A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts