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Ruptured Aorta-Iliac Aneurysms: Endo vs. Surgery (ECAR)
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, July 2008
Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00577616
  Purpose

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
Ruptured Aorta-Iliac Aneurysms
Procedure: Endovascular repair

MedlinePlus related topics: Aneurysms
U.S. FDA Resources
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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Mortality at 30 days after the treatment(endovascular repair versus conventional repair) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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
1
Endovascular repair
Procedure: Endovascular repair
Endovascular repair of the asymptomatic aneurysms of the abdominal aorta
2
conventional surgery repair
Procedure: Endovascular repair
Endovascular repair of the asymptomatic aneurysms of the abdominal aorta

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577616

Contacts
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

Locations
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            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Pascal Desgranges, PUPH Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Endovascular repair
Ruptured aorta-iliac aneurysms
Mortality at 30 days

Study placed in the following topic categories:
Aneurysm
Wounds and Injuries
Vascular Diseases
Disorders of Environmental Origin
Rupture
Iliac Aneurysm

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009