Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair (NCT00224718) | Clinical Trial Compass
CompletedNot Applicable
Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair
France306 participantsStarted 2003-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.