NCT01168037

Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Aortic Aneurysms

Medical and Economical Evaluation of Endovascular Therapy of Complex Aortic Aneurysms (Para- & Supra- Renal Abdominal Aortic Aneurysms, Type 4 THORACO-Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 270 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of pararenal, supra-renal and type 4 THORACO-abdominal aortic aneurysms. The primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (250 patients (amendment) treated in 8 University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH).

Detailed description

The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of pararenal, supra-renal and type 4 THORACO-abdominal aortic aneurysms. The primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (250 patients (amendment) treated in 8 University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH). In-hospital morbidity are similarly expected to be lower in the endovascular group. We also wish to demonstrate that endovascular repair does not represent a significant over-cost, as compared to open repair. The cost of the implantable medical device (IMD), of follow-up screening, and of eventual repeated interventions should be compensated by a reduced stay in intensive care unit ICU, and by a reduced in-hospital length of stay.

Conditions

• Aortic Aneurysms

Interventions

Type	Name	Description
DEVICE	Endovascular aortic repair with branched/fenestrated stent-graft	Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram
PROCEDURE	Open Surgical Repair	aortic replacement with revascularization of visceral arteries

Timeline

• Start date: 2009-06-17
• Primary completion: 2015-02-09
• Completion: 2015-02-09
• First posted: 2010-07-22
• Last updated: 2017-10-19

Locations

1 site across 1 country: France