Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair (ACE)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Elective Abdominal Aortic Aneurysm

Treatments

Procedure: Endovascular repair (with endograft)

Procedure: Open repair

Study type

Interventional

Funder types

Other

Identifiers

NCT00224718

AOM 98167

P000708

Details and patient eligibility

About

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.

Full 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.

Enrollment

306 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

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