Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Thoracal Abdominal Aneurysms (Windows2)
Recruitment status was: Active, not recruiting
|Aortic Aneurysm||Procedure: Endovascular aortic repair Procedure: Open surgical repair|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Medical & Economical Evaluation of Endovascular Therapy of Complex Thoracal Abdominal Aneurysms (Type 1-3 Thoracal Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts|
- mortality [ Time Frame: 30-day postoperative ]
- complications [ Time Frame: 30-day postoperative ]
- Length of Intensive Care Unit (ICU) stay [ Time Frame: 30-day postoperative ]
- Length of Hospital stay [ Time Frame: 30-day postoperative ]
- Overall cost [ Time Frame: 30-day postoperative ]
- Reinterventions [ Time Frame: 2-year follow up ]
- Global survival [ Time Frame: 2-year follow up ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Endovascular therapy branched
Endovascular therapy branched or fenestrated stent-graft
Procedure: Endovascular aortic repair
Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram
Open surgical repair
Open surgical repair or aortic replacement with revascularization of visceral arteries
Procedure: Open surgical repair
Conventional therapy in France with the national database of the M.O.H.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354821
|Henri Mondor Hospital|
|Creteil, France, 94010|
|Principal Investigator:||Jean-Pierre Becquemin, PU-PH||Assistance Publique - Hôpitaux de Paris|