Impact of Stentgraft Treatment on Kidney Function in Aortic Aneurysm Patients
Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study
This study is testing how different ways of fixing stentgrafts can affect kidney function in patients with abdominal aortic aneurysms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg, VastraGotaland) |
| Trial ID | NCT04754659 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with non-ruptured infrarenal or iliac aneurysms who meet the anatomical criteria for stentgraft treatment.
Not a fit: Patients currently on dialysis or those with anatomical conditions that prevent the use of both fixation types will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved renal outcomes for patients undergoing stentgraft treatment for abdominal aortic aneurysms.
How similar studies have performed: Other studies have explored stentgraft treatments, but this specific approach comparing fixation types is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gothenburg, VastraGotaland
- Sahlgrenska University Hospital — Gothenburg, VastraGotaland, Sweden (Recruiting)
Study contacts
- Study coordinator: Per Skoog, M.D
- Email: per.skoog@vgregion.se
- Phone: +46316021000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.