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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00577616 |
The aim of this multicenter randomized trial is to compare the endovascular repair versus conventional repair for ruptured aorta-iliac aneurysms observed on CT scan in stable patients with suitable anatomy. The main awaited result is the significant reduction of the mortality of the conventional repair.
Condition | Intervention |
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Ruptured Aorta-Iliac Aneurysms |
Procedure: Endovascular repair |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Study Comparing Endovascular Repair Versus Conventional Repair for Ruptured Aorta-Iliac Aneurysms |
Estimated Enrollment: | 160 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Endovascular repair
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Procedure: Endovascular repair
Endovascular repair of the asymptomatic aneurysms of the abdominal aorta
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2
conventional surgery repair
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Procedure: Endovascular repair
Endovascular repair of the asymptomatic aneurysms of the abdominal aorta
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The total death rate of ruptured aorta-iliac aneurysms is around 90%. A meta-analysis published by Bown et al. in 2002 in British Journal of Surgery finds on 171 studies compiled since 1955 an operational mortality post of the conventional surgery of 47%. This figure of post-operative mortality seems incompressible since many years in spite of the improvement of the techniques of anaesthesia and the surgery. The endovascular repair of the asymptomatic aneurysms of the abdominal aorta proved to be feasible and effective. In studies with limited and selected patients, the endovascular repair of ruptured aorta-iliac aneurysms seems to show a reduction in post-operative mortality in the average of 20%. However, the only comparative study (n=32) could not highlight of significant difference.This justifies a multicentric randomized study of which the goal is to compare the Endovascular repair and the Conventional repair in a cohort of a minimum of 160 patients carrying a Ruptured aorta-iliac Aneurysm(study name: ECAR) observed on CT-scan and being able to profit from the 2 techniques.The emergency does not allow the randomization by patient. The unit of randomization will be the week for each center, one week of endovascular treatment in alternation with one week of treatment by conventional repair and that in a synchronous way for the unit of all the centers of the study. The first week will be devoted to the conventional surgery and will be effective as of the opening of the first center. The principal objective is to compare mortality at 30 days in both groups. The secondary objectives are to compare in the 2 groups:• Morbidity (cardiac, pulmonary, renal, neurological, digestive) at 30 days.• Duration of stay in intensive care unit. The principal awaited results are a significant reduction in the mortality of the endovascular repair compared to the conventional surgery and a reduction in morbidity.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Aneurysm developed on native infra-renal aorta or iliac.
Exclusion Criteria:
Contact: Pascal Desgranges, PU-PH | (0) 1 49 81 24 05 ext +33 | pascal.desgranges@hmn.aphp.fr |
Contact: Amor Krimi | (0) 1 49 81 37 98 ext + 33 | amor.krimi@hmn.aphp.fr |
France | |
CHU Henri Mondor | Recruiting |
Creteil, France, 94000 | |
Contact: Pascal Desgranges, PUPH 01 49 81 24 05 ext +33 pascal.desgranges@hmn.aphp.fr | |
Principal Investigator: Pascal Desgranges, PUPH |
Principal Investigator: | Pascal Desgranges, PUPH | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Cninical Research of Developpement ( Mathieu QUINTIN ) |
Study ID Numbers: | AOM06055, K060216 |
Study First Received: | December 19, 2007 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00577616 |
Health Authority: | France: Ministry of Health |
Endovascular repair Ruptured aorta-iliac aneurysms Mortality at 30 days |
Aneurysm Wounds and Injuries Vascular Diseases |
Disorders of Environmental Origin Rupture Iliac Aneurysm |
Cardiovascular Diseases |