Aortic Aneurysms Clinical Trial
Official title:
Medical and Economical Evaluation of Endovascular Therapy of Complex Aortic Aneurysms (Para- & Supra- Renal Abdominal Aortic Aneurysms, Type 4 THORACO-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 pararenal,
supra-renal and type 4 THORACO-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
(250 patients (amendment) treated in 8 University hospitals with significant experience of
the technique) and open repair (660 similar patients analyzed form the national database of
the MOH).
The aim of this study is to prospectively compare the perioperative mortality severe
morbidity and the costs of endovascular versus conventional surgical repair of pararenal,
supra-renal and type 4 THORACO-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
(250 patients (amendment) treated in 8 University hospitals with significant experience of
the technique) and open repair (660 similar patients analyzed form the national database of
the MOH).
In-hospital morbidity are similarly expected to be lower in the endovascular group. We also
wish to demonstrate that endovascular repair does not represent a significant over-cost, 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.
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