A PMCF Study in Patients With Infrarenal Aortic Aneurysm Treated With the E-tegra Stent Graft System (NCT04765176) | Clinical Trial Compass
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A PMCF Study in Patients With Infrarenal Aortic Aneurysm Treated With the E-tegra Stent Graft System
Netherlands151 participantsStarted 2021-03-01
Plain-language summary
The EASY post-market clinical follow-up study is undertaken to demonstrate safety and clinical performance of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.
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:
* Age ≥ 18
* Patient must have an infrarenal aortic aneurysm with diameter ≥ 50 mm in females and ≥ 55 mm in males, or infrarenal aortic aneurysm with 40-50 mm that has increased in size by ≥ 1 cm per year
* Patient is elegible for treatment inside the instructions for use of the E-tegra Stent Graft System
* Patient is able and willing to undergo follow-up imaging and examinations prior to discharge from the hospital, at 30 days and 12 months, and annually thereafter until 5 years follow-up
* Patient understands and has signed the Informed Consent Form prior to intervention
* Patient has a life expectancy of at least 5 years
Exclusion Criteria:
* Patient with severe calcification or thrombi in the proximal sealing zone
* Patient with infectious aneurysm
* Patient with inflammatory aneurysm
* Patient with pseudoaneurysm
* Patient with symptomatic aneurysm
* Patient with ruptured or traumatic aneurysm
* Patient with suprarenal, juxtarenal, or pararenal aneurysm
* Patient with aortic dissection
* Patient with a reversed conical neck that is defined as a \> 3 mm distal increase over a 15 mm length
* Patient in which the E-tegra Stent Graft System is used in combination with proximal or distal extenders of another company.
* Patient who is planned to be treated with an adjunctive aortic bare metal stent or a fenestrated stent graft
* Patient who is planned to be treated with a chimney / chimneys in the renal or visceral vessels
* Patient who is planned to be…
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.