Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal  Surgery Versus Endoprosthesis 

Conditions
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Elective Abdominal Aortic Aneurysm

Intervention / Treatment
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* Procedure: Endovascular repair (with endograft)
* Procedure: Open repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>surgery - open repair | Procedure: Open repair<br>* Conventional repair consist in open repair. Different types of surgery can be done : minimal incision aortic surgery (MIAS), transperitoneal approach (TPA), retroperitoneal repair, or conventional median laparotomy.<br>|
| Experimental: 2<br>endovascular procedure | Procedure: Endovascular repair (with endograft)<br>* An endovascular stent graft is a tube composed of fabric supported by a metal mesh called a stent. It can be used for a variety of conditions involving the blood vessels, but most commonly to reinforce a weak spot in an artery called an aneurysm. Over time, blood pressure and other factors can cause this weak area to bulge like a balloon and eventually enlarge and rupture. The stent graft seals tightly with your artery above and below the aneurysm. The graft is stronger than the weakened artery and allows blood to pass through it without pushing on the bulge. Physicians typically use endovascular stent grafting to treat abdominal aortic aneurysms (AAAs).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death and major adverse events |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor adverse events (systemic vascular or non vascular complications) |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal aortic aneurysm, Endograft, Open repair, Endovascular repair, AAA