Status:
RECRUITING
Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm
Lead Sponsor:
Vastra Gotaland Region
Conditions:
Aortic Aneurysm, Abdominal
Renal Insufficiency
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 f...
Detailed Description
This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm with stentgrafts either with active supra- or infrarenal fixatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT04754659
Start Date
December 19 2022
End Date
December 1 2027
Last Update
May 7 2024
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, VastraGotaland, Sweden