An observational study in Aortic Aneurysms, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's enrollment of 270 is above the median of 151 across 443 observational studies indexed under Aneurysm.
Browse Aneurysm studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with an Abdominal aortic aneurysm over 5 cm in diameter or with a diameter increase over 1 cm in 1 year and a PSRAA defined by:
The following anatomical inclusion criteria must be met:
Exclusion Criteria:
Open Surgical Repair (aortic replacement with revascularization of visceral arteries)
Procedure: Open Surgical Repair
Endovascular therapy branched or fenestrated stent-graft
Device: Endovascular aortic repair with branched/fenestrated stent-graft
Endovascular therapy branched or fenestrated stent-graft (vascutek anaconda)
Device: Endovascular aortic repair with branched/fenestrated stent-graft
Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram
Also known as: Endovascular aortic repair
aortic replacement with revascularization of visceral arteries
30-day postoperative 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
Mortality in touch with aneurysm
Time frame: 2-year follow up
Annual cost (1 month, 6 month, 1 year and 2 year Follow-up screening )
Time frame: 2-year follow up
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris