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)

Sahlgrenska University Hospital

Gothenburg, VastraGotaland, Sweden

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NCT04754659


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