RecruitingNot Applicable

Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

Sweden252 participantsStarted 2022-12-19

Plain-language summary

This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm (AAA) with stentgrafts either with active supra- or infrarenal fixation.

Who can participate

Age range

18 Years – 90 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: * Willing and able to provide written informed consent * Meet criteria for non-ruptured infrarenal/iliac aneurysm * Suitable anatomy for treatment with an approved device (CE-marked) stentgraft according to the manufacturers' instructions for use for AAA. * Accepted for treatment with endovascular aortic repair (EVAR) by the participating vascular center. Exclusion Criteria: * Ongoing or planned dialysis * AAA treatment requiring stents or stentgrafts in renal and/or visceral arteries * Inability to independently complete HRQoL questionnaires due to language barriers * Anatomical preconditions that do not allow both types of fixation to be used interchangeably, i.e. very advanced suprarenal tortuosity (\>60 degrees), advanced suprarenal dilatation or infrarenal thrombus \>25% of circumference.

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

Number of participants with decreased renal function (composite endpoint together with the endpoint below)

Timeframe: Change between baseline renal function and at 3 years.

Number of participants with new renal infarct

Timeframe: Change in numbers of new renal infarcts between baseline and at 3 years.

Trial details

NCT IDNCT04754659

SponsorVastra Gotaland Region

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Per Skoog, M.D

+46316021000 per.skoog@vgregion.se

View on ClinicalTrials.gov More Aortic Aneurysm, Abdominal trials