Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair

Not Applicable

Completed

• Conditions: Elective Abdominal Aortic Aneurysm
• Interventions: Procedure: Open repair; Procedure: Endovascular repair (with endograft)

• Registration Number: NCT00224718
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.

The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.

Detailed Description

ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.

The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-23
• Primary Completion: 2008-02
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-03-31
• Last Update Posted: 2009-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• Patients aged 50 years old or more (more than 80 possible depending on physiological age)
• Level 0, 1, or 2 of operative risk
• Abdominal aortic aneurysm with a diameter > or equal to 50 mm or > or equal to 40 mm if rapid growing (10 mm or more in a year), or painful, or saccular aneurysms, or aneurisms of common iliac arteries with a diameter equal or superior to 30 mm; or women with a diameter equal to 45 mm;
• Aortic neck superior or equal to 1.5 cm
• No stenosis superior or equal to 75% of the superior mesenteric artery
• Proximal neck angulation inferior to 80°
• Diameter of the iliac arteries compatible with introducer sheath
• Inform consent signed

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Exclusion Criteria

• Aneurysm involving the renal arteries or with the length of the neck less than 1.5 cm
• Thrombus or major calcification in the neck
• Diameter of the iliac arteries not compatible with introducer sheath
• Level 3 of operative risk
• History of major iodine allergy (Quincke oedema, anaphylactic shock)
• Other comorbidity with life expectancy less than 6 months
• Follow up impossible during the trial
• Participation in another trial
• Inform consent not signed

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Open repair	surgery - open repair
2	Endovascular repair (with endograft)	endovascular procedure

Primary Outcome Measures

Name	Time	Method
Death and major adverse events	4 years

Secondary Outcome Measures

Name	Time	Method
Minor adverse events (systemic vascular or non vascular complications)	4 years

Trial Locations

Locations (1)

Hopital Henri Mondor; 🇫🇷 Creteil, France