Ruptured Aorta-iliac Aneurysms: Endo vs. Surgery

NCT00577616 | Completed DMC

• 2 other identifiers: AOM06055K060216
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Ruptured Aorta-iliac Aneurysms

Keywords

Endovascular repair; Ruptured aorta-iliac aneurysms; Mortality at 30 days

Outcome Measures

Primary Outcomes (1)

• Mortality at 30 days after the treatment(endovascular repair versus conventional repair)

  30 days after the treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

1

OTHER

Endovascular repair

Procedure: Endovascular repair

2

OTHER

conventional surgery repair

Procedure: Endovascular repair

Interventions

Endovascular repair PROCEDURE

Endovascular repair of the asymptomatic aneurysms of the abdominal aorta

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable hemodynamic condition
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Henri Mondor

Créteil, 94000, France

Location

Related Publications (3)

• 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.

  PMID: 16061405 BACKGROUND

• 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.

  PMID: 26001320 DERIVED

• 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.

  PMID: 20117503 DERIVED

MeSH Terms

Interventions

Endovascular Aneurysm Repair

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Pascal Desgranges, PUPH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 20, 2007
• Study Start: December 1, 2007
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2014
• Last Updated: October 23, 2014

Record last verified: 2013-07

Locations

FR (1)