Clinical trial NCT01168037: Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Aortic Aneurysms
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysms
Keywords: Aorta
Aneurysm
endovascular
stent-graft
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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:

* Infrarenal aortic neck \< 15 mm
* or extent of the aneurismal process to the suprarenal aorta

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 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).

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day postoperative mortality
timeFrame: 30-day postoperative
Secondary outcomes:
measure: complications
timeFrame: 30-day postoperative
measure: Length of Intensive Care Unit (ICU) stay
timeFrame: 30-day postoperative
measure: Length of Hospital stay
timeFrame: 30-day postoperative
measure: Overall cost
timeFrame: 30-day postoperative
measure: Reinterventions
timeFrame: 2-year follow up
measure: Global survival
timeFrame: 2-year follow up
measure: Mortality in touch with aneurysm
timeFrame: 2-year follow up
measure: Annual cost (1 month, 6 month, 1 year and 2 year Follow-up screening )
timeFrame: 2-year follow up
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Pierre Becquemin, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Neill S, Greenberg RK, Haddad F, Resch T, Sereika J, Katz E. A prospective analysis of fenestrated endovascular grafting: intermediate-term outcomes. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):115-23. doi: 10.1016/j.ejvs.2006.01.015. Epub 2006 Mar 31.
citation: Michel M, Becquemin JP, Clement MC, Marzelle J, Quelen C, Durand-Zaleski I; WINDOW Trial Participants. Editor's choice - thirty day outcomes and costs of fenestrated and branched stent grafts versus open repair for complex aortic aneurysms. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):189-96. doi: 10.1016/j.ejvs.2015.04.012. Epub 2015 Jun 19.
citation: Marzelle J, Presles E, Becquemin JP; WINDOWS trial participants. Results and factors affecting early outcome of fenestrated and/or branched stent grafts for aortic aneurysms: a multicenter prospective study. Ann Surg. 2015 Jan;261(1):197-206. doi: 10.1097/SLA.0000000000000612.
citation: Banno H, Kobeiter H, Brossier J, Marzelle J, Presles E, Becquemin JP. Inter-observer variability in sizing fenestrated and/or branched aortic stent-grafts. Eur J Vasc Endovasc Surg. 2014 Jan;47(1):45-52. doi: 10.1016/j.ejvs.2013.10.008. Epub 2013 Oct 23.