Status:
COMPLETED
Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Elective Abdominal Aortic Aneurysm
Eligibility:
All Genders
50+ years
Phase:
NA
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 ...
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 surgi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00224718
Start Date
January 1 2003
End Date
February 1 2009
Last Update
April 1 2009
Active Locations (1)
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1
Hopital Henri Mondor
Créteil, France, 94 010