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 range18 Years – 90 Years

SexALL

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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.

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