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

Not Applicable

• Conditions: Aortic Aneurysm
• Interventions: Procedure: Endovascular aortic repair; Procedure: Open surgical repair

• Registration Number: NCT01354821
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 type 1, 2 and 3 thoracal abdominal aortic aneurysms.

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 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Primary Completion: 2014-01
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-29
• Last Update Posted: 2014-10-30
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovascular therapy branched	Endovascular aortic repair	Endovascular therapy branched or fenestrated stent-graft
Open surgical repair	Open surgical repair	Open surgical repair or aortic replacement with revascularization of visceral arteries

Primary Outcome Measures

Name	Time	Method
mortality	30-day postoperative

Secondary Outcome Measures

Name	Time	Method
Global survival	2-year follow up
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

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France