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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Aortic Aneurysms

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


Participation Criteria
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Eligibility Criteria
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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: Limited expected life expectancy Emergency cases Refuse to participate to the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open repair<br>Open Surgical Repair (aortic replacement with revascularization of visceral arteries) | Procedure: Open Surgical Repair<br>* aortic replacement with revascularization of visceral arteries<br>|
| Endovascular (Windows 1)<br>Endovascular therapy branched or fenestrated stent-graft | Device: Endovascular aortic repair with branched/fenestrated stent-graft<br>* Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram<br>* Other names: Endovascular aortic repair;|
| Endovascular (Windows 3)<br>Endovascular therapy branched or fenestrated stent-graft (vascutek anaconda) | Device: Endovascular aortic repair with branched/fenestrated stent-graft<br>* Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram<br>* Other names: Endovascular aortic repair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day postoperative mortality |  | 30-day postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Global survival |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aorta, Aneurysm, endovascular, stent-graft