Clinical Trial: Ruptured Aorta-iliac Aneurysms: Endo vs. Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Study Comparing Endovascular Repair Versus Conventional Repair for Ruptured Aorta-iliac Aneurysms

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Mortality at 30 days after the treatment(endovascular repair versus conventional repair) [ Time Frame: 30 days after the treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Compare at 30 days after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity, other…- Duration of stay in intensive care unit- Quantity of blood transfusions [ Time Frame: 30 days after the treatment ]
  • Compare at 6 month after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity (amendment 6) [ Time Frame: 6 month after treatment ]
  • Compare at one year after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity (amendment 6) [ Time Frame: one year after the treatment ]


Original Secondary Outcome: Compare at 30 days after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity, other…- Duration of stay in intensive care unit- Quantity of blood transfusions [ Time Frame: 30 days after the treatment ]

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: December 19, 2007
Date Started: December 2007
Date Completion:
Last Updated: October 22, 2014
Last Verified: July 2013