The Need for Clinical Trials of Endovascular Abdominal Aortic Aneurysm Stent-Graft Repair: The EUROSTAR Project

Abstract

EUROSTAR(EUROpean collaborators on Stent-graft Techniques for abdominal aortic Aneurysm Repair) was established for the purpose of combining and studying data on endovascular abdominal aortic aneurysm (AAA) repair. EUROSTAR is independent of any commercial interest and has as its ultimate goal an independent, scientifically reliable assessment of endovascular AAA grafting. A standardized case record form is used for data collection and transmission, and the database is maintained in a central registry office. A comprehensive set of clinical, imaging, technical, and laboratory data obtained at initial admission and follow-up are recorded; these data are analyzed periodically and reports generated on the collated experience. As a first priority, an observational study without controls was initiated in July 1996 to address the issues of procedural safety, device durability, and long-term effect upon the aneurysms. Several ancillary studies have been initiated, including a “Retrieval and Analysis Study” for the evaluation of explanted devices. While a randomized study does not seem feasible at present, this may be organized at the appropriate time when the devices and techniques become more standardized.