Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Thoracal Abdominal Aneurysms (Windows2)
|ClinicalTrials.gov Identifier: NCT01354821|
Recruitment Status : Unknown
Verified October 2014 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Active, not recruiting
First Posted : May 17, 2011
Last Update Posted : October 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Aortic Aneurysm||Procedure: Endovascular aortic repair Procedure: Open surgical repair||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Medical & Economical Evaluation of Endovascular Therapy of Complex Thoracal Abdominal Aneurysms (Type 1-3 Thoracal Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||December 2015|
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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354821
|Henri Mondor Hospital|
|Creteil, France, 94010|
|Principal Investigator:||Jean-Pierre Becquemin, PU-PH||Assistance Publique - Hôpitaux de Paris|