Registry Based Trials

Endovascular aneurysm repair (EVAR) in the treatment of ruptured abdominal aortic aneurysms (rAAA) is an MDEpiNet Coordinating Center-supported clinical trial project nested under the International Consortium of Vascular Registries. The program at the University of Alabama Birmingham, which has been established as an MDEpiNet collaborator for this and future projects, is led by Adam Beck.

 

The aim of this project is to evaluate the safety and effectiveness of EVAR devices used to treat rAAA (compared to open rAAA repair) by international evaluation in the existing International Consortium of Vascular Registries registries. The project is intended to provide manufacturers of currently approved EVAR devices (Cook, Endologix, Gore, Medtronic) with real-world data allowing them to understand better how their devices perform in the setting of ruptured aneurysm.

As EVAR is now the primary treatment for AAA, there is increasing importance to evaluate these parameters from a surgical quality and outcome perspective. Additionally, these data could be used as support for a regulatory application to modify the labeling of the endovascular grafts evaluated in this study with respect to rAAA.

The central purpose of this project is to evaluate in-hospital mortality after EVAR for rAAA in a multinational registry collaboration using mortality associated with standard open repair to establish performance goals. Given that untreated rAAA carries a mortality approaching 100%, the project will focus specifically on survival to discharge. Further, the long-term safety and effectiveness of these EVAR devices has been extensively studied and established for elective AAA repair.  The major endpoint for this project is improving initial survival based on the improvement of outcomes after rAAA repair.

 

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