Overview

This trial is active, not recruiting.

Condition aortic aneurysm
Treatments endovascular aortic repair, open surgical repair
Sponsor Assistance Publique - Hôpitaux de Paris
Start date November 2009
End date January 2014
Trial size 49 participants
Trial identifier NCT01354821, P090209

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Endovascular therapy branched or fenestrated stent-graft
endovascular aortic repair Endovascular aortic repair
Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram
(Other)
Open surgical repair or aortic replacement with revascularization of visceral arteries
open surgical repair Open surgical repair
Conventional therapy in France with the national database of the M.O.H.

Primary Outcomes

Measure
mortality
time frame: 30-day postoperative

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Medical & Economical Evaluation of Endovascular Therapy of Complex Thoracal Abdominal Aneurysms (Type 1-3 Thoracal Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts
Principal investigator Jean-Pierre Becquemin, PU-PH
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.