CompletedNot Applicable

Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms

France180 participantsStarted 2012-06

Plain-language summary

The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is the subject of this observational study. 180 patients will be implanted with the Anaconda™ Stent Graft System and will be followed-up annually for 5 years post-implant. The study will satisfy the requirements of the French National Authority for Health (Haute Autorité de santé) and the data collected will be used for reimbursement renewal.

Who can participate

Age range

18 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: * Any patient implanted with the Vascutek Anaconda™ Stent Graft System for the treatment of a non-ruptured infrarenal Abdominal Aortic Aneurysm (AAA) Exclusion Criteria: * Patients for whom clinical follow-up is impossible and cannot return for check-up visits

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.

What they're measuring

Overall mortality rate

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Mortality rate related to rupture of the aneurysm and relationship to the stent

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Change in diameter of the aneurysm

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Rate of Type I, II and III endoleaks

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Surgical conversion rate

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Rate of endovascular or surgical revisions

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Trial details

NCT IDNCT01783184

SponsorVascutek Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-10

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm trials

Plain-language summary

Who can participate

Age range

18 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.

What they're measuring

Overall mortality rate

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Mortality rate related to rupture of the aneurysm and relationship to the stent

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Change in diameter of the aneurysm

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Rate of Type I, II and III endoleaks

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Surgical conversion rate

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Rate of endovascular or surgical revisions

Timeframe: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years