This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.
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:
* Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Guntner et al:
\- Open IMA AND
* 1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) \>17,5cm2 OR
* 2 patent lumbars AND a CSAIMA \>15cm2 OR
* 3 patent lumbars AND a CSAIMA \>12,5 cm2 OR
* 4 patent lumbars AND a CSAIMA \>10 cm2 OR
* 5 patent lumbars AND a CSAIMA \>7,5 cm2
* Infrarenal neck according to the IFU of the EVAR device
* Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used
* Patient having a life expectation of at least 2 years
* Being older than 18 years
* Willing and able to comply with the requirements of this clinical study
Exclusion Criteria:
* Patient not able or willing to give written Informed Consent
* Patient undergoing emergency procedures
* Patient undergoing EVAR for ruptured or symptomatic AAA,
* Patient with a suprarenal AAA
* Patient with an inflammatory AAA (more than minimal wall thickening)
* Patient with an infrarenal neck unsuitable for endovascular fixation (including so called "hostile necks") or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used
* Patient in which a bilateral retroperitoneal incision is required for EVAR
* Patient in which a sacrifice of both hypogastric arteries is required
* Patient with anatomi…
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.