UnknownNot Applicable

ANEUFIX for Endoleak Type II Repair

Belgium, Netherlands40 participantsStarted 2020-05-13

Plain-language summary

The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago.

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

. Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
. An endoleak confirmed on a CT scan that should be done within 180 days prior to procedure but preferably within 90 days prior to screening demonstrating the high likelihood of the isolated nature of the endoleak; AND
. An aneurysm sac growing after EVAR of minimal 10 mm (per European Guidelines) as documented in the preceding 90 days by means of CT-imaging (or alternative imaging techniques) and based upon sac diameter measurements; AND
. An aneurysm sac that can be punctured via a translumbar approach; AND
. Possibility to withhold anti-thrombogenic medication temporarily; AND
. Ability and willingness to undergo the translumbar procedure; AND
. Being older than 18 years.

Exclusion criteria

. Patient not able or willing to give written Informed Consent; OR
. Patient undergoing emergency procedures; OR
. Patient with traumatic vascular injury; OR

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

Technical success rate

Timeframe: 24 hours

Trial details

NCT IDNCT03918460

SponsorTripleMed B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-31

Contact for this trial

Tjeerd Homsma

+31 (0)6 29078003 t.homsma@triple-med.com

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm trials