Impact of Stentgraft Treatment on Kidney Function in Aortic Aneurysm Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial investigates how different stentgraft fixation methods affect renal function in patients undergoing treatment for infrarenal abdominal aortic aneurysm. Participants will be recruited across Scandinavia and will undergo computerized randomization to receive either active supra- or infrarenal fixation. Baseline data will be collected, and follow-up assessments will occur at 1 month, 1 year, 3 years, and 5 years, including blood tests and CT scans to evaluate renal function and stentgraft performance. Health-related quality of life will also be assessed through questionnaires at these follow-up points.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sahlgrenska University Hospital
  Gothenburg, VastraGotaland, Sweden Recruiting

Study contacts

• Study coordinator: Per Skoog, M.D
• Email: per.skoog@vgregion.se
• Phone: +46316021000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.