Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Thoracal Abdominal 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 type 1, 2 and 3 thoracal abdominal aortic aneurysms.

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 type 1, 2 and 3 thoracal 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 (50 patients (amendment n.5 - 9/07/2013) treated in 5 University hospitals with significant experience of the technique) and open repair (220 similar patients analyzed from the national database of the MOH). In-hospital morbidity are similarly expected to be lower in the endovascular group. The investigators also wish to demonstrate that endovascular repair does not represent a significant overcost, 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 & Economical Evaluation of Endovascular Therapy of Complex Thoracal Abdominal Aneurysms (Type 1-3 Thoracal Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts

Conditions
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Aortic Aneurysm

Intervention / Treatment
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* Procedure: Endovascular aortic repair
* 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endovascular therapy branched<br>Endovascular therapy branched or fenestrated stent-graft | Procedure: Endovascular aortic repair<br>* Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram<br>|
| Other: Open surgical repair<br>Open surgical repair or aortic replacement with revascularization of visceral arteries | Procedure: Open surgical repair<br>* Conventional therapy in France with the national database of the M.O.H.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

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