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

Completed

Interventions: Procedure: Open Surgical Repair
Device: Endovascular aortic repair with branched/fenestrated stent-graft

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

The following anatomical inclusion criteria must be met:

Absence of significant angulations (< 60°) of aorta or of iliac arteries
Absence of tight stenosis (>70%) of more than one target artery (renal or visceral artery to be perfused from the side holes of the stent-graft)
Diameter of target arteries over 5 mm
Iliac and femoral arteries allowing insertion of the delivery system (> 7 mm) or suitable for insertion of an access conduit

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Open repair	Open Surgical Repair	Open Surgical Repair (aortic replacement with revascularization of visceral arteries)
Endovascular (Windows 1)	Endovascular aortic repair with branched/fenestrated stent-graft	Endovascular therapy branched or fenestrated stent-graft
Endovascular (Windows 3)	Endovascular aortic repair with branched/fenestrated stent-graft	Endovascular therapy branched or fenestrated stent-graft (vascutek anaconda)

Primary Outcome Measures

Name	Time	Method
30-day postoperative mortality	30-day postoperative

Secondary Outcome Measures

Name	Time	Method
complications	30-day postoperative
Length of Intensive Care Unit (ICU) stay	30-day postoperative
Length of Hospital stay	30-day postoperative
Overall cost	30-day postoperative
Reinterventions	2-year follow up
Mortality in touch with aneurysm	2-year follow up
Annual cost (1 month, 6 month, 1 year and 2 year Follow-up screening )	2-year follow up
Global survival	2-year follow up

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