Ruptured Aorta-iliac Aneurysms: Endo vs. Surgery (ECAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Ruptured Aorta-iliac Aneurysms
• Intervention / Treatment: Procedure: Endovascular repair

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94000
    • Chu Henri Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >= 18 years
• Ruptured aorta-iliac aneurysms diagnosed by CT
• scan with injection.

• Aneurysm developed on native infra-renal aorta or iliac.

  • Non infectious false aneurysms developed on prosthesis (Deleted by amendment n°1 at the request of AFSSAPS)
  • Ruptured aneurysm after endoprosthesis (Deleted by amendment n°1 at the request of AFSSAPS)
• Stable hemodynamic condition: systolic blood pressure on arrival higher than 80 mmHg in the absence of continuous vasopressive drugs administration.
• Anatomic criteria :length of aortic proximal neck >10 mm, diameter of aortic proximal neck < 32 mm, Absence of aortic neck angulation > 90° and patent iliac without important stenosis or tortuosity.
• Technical constraints (validation of experience form) : Trained operator (at least 15 endoprosthesis in asymptomatic patients), Endovascular materials at disposal

Exclusion Criteria:

• Unstable hemodynamic condition
• Anatomic criteria of non-inclusion
• Asymptomatic aneurysm
• Non-ruptured symptomatic aneurysm or aneurysm complicated with emboli.
• Mycotic aneurysm, infectious false aneurysms
• Post-traumatic aneurysm
• Supra-renal thoracic-abdominal aneurysm
• Impossibility to obtain a CT-scan with injection
• Patient non-affiliated to the social security and the protected people
• Pregnancy or breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Endovascular repair	Procedure: Endovascular repair; Endovascular repair of the asymptomatic aneurysms of the abdominal aorta
Other: 2; conventional surgery repair	Procedure: Endovascular repair; Endovascular repair of the asymptomatic aneurysms of the abdominal aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality at 30 days after the treatment(endovascular repair versus conventional repair)	30 days after the treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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	30 days after the treatment
Compare at 6 month after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity (amendment 6)	6 month after treatment
Compare at one year after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity (amendment 6)	one year after the treatment

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Pascal Desgranges, PUPH, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Alsac JM, Desgranges P, Kobeiter H, Becquemin JP. Emergency endovascular repair for ruptured abdominal aortic aneurysms: feasibility and comparison of early results with conventional open repair. Eur J Vasc Endovasc Surg. 2005 Dec;30(6):632-9. doi: 10.1016/j.ejvs.2005.06.010. Epub 2005 Aug 1.
• Desgranges P, Kobeiter H, Katsahian S, Bouffi M, Gouny P, Favre JP, Alsac JM, Sobocinski J, Julia P, Alimi Y, Steinmetz E, Haulon S, Alric P, Canaud L, Castier Y, Jean-Baptiste E, Hassen-Khodja R, Lermusiaux P, Feugier P, Destrieux-Garnier L, Charles-Nelson A, Marzelle J, Majewski M, Bourmaud A, Becquemin JP; ECAR Investigators. Editor's Choice - ECAR (Endovasculaire ou Chirurgie dans les Anevrysmes aorto-iliaques Rompus): A French Randomized Controlled Trial of Endovascular Versus Open Surgical Repair of Ruptured Aorto-iliac Aneurysms. Eur J Vasc Endovasc Surg. 2015 Sep;50(3):303-10. doi: 10.1016/j.ejvs.2015.03.028. Epub 2015 May 20.
• Desgranges P, Kobeiter H, Castier Y, Senechal M, Majewski M, Krimi A. The Endovasculaire vs Chirurgie dans les Anevrysmes Rompus PROTOCOL trial update. J Vasc Surg. 2010 Jan;51(1):267-70. doi: 10.1016/j.jvs.2009.10.128.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 19, 2007
• First Posted (Estimate): December 20, 2007

Study Record Updates

• Last Update Posted (Estimate): October 23, 2014
• Last Update Submitted That Met QC Criteria: October 22, 2014
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Endovascular repair; Ruptured aorta-iliac aneurysms; Mortality at 30 days
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Iliac Aneurysm
• Other Study ID Numbers: AOM06055; K060216