Aortic Aneurysm Clinical Trial
Official title:
Medical & Economical Evaluation of Endovascular Therapy of Complex Thoracal Abdominal Aneurysms (Type 1-3 Thoracal Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts
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 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.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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