Aortic Aneurysm
Conditions
Keywords
Aorta, Aneurysm, endovascular, stent-graft
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.
Interventions
PROCEDUREEndovascular aortic repair
Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram
PROCEDUREOpen surgical repair
Conventional therapy in France with the national database of the M.O.H.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mortality | 30-day postoperative |
Secondary
| Measure | Time frame |
|---|---|
| Length of Intensive Care Unit (ICU) stay | 30-day postoperative |
| Length of Hospital stay | 30-day postoperative |
| complications | 30-day postoperative |
| Reinterventions | 2-year follow up |
| Global survival | 2-year follow up |
| Overall cost | 30-day postoperative |
Countries
France
Outcome results
None listed