RecruitingNot ApplicableNCT04754659
Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm
Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study
Sponsor
Vastra Gotaland Region
Enrollment
252 participants
Start Date
Dec 19, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 90 Years
Inclusion Criteria4
- 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 Criteria4
- 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.
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Interventions
DEVICEStentgraft
Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04754659
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