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Search / Trial NCT04754659

Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

Launched by VASTRA GOTALAND REGION · Feb 11, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Abdominal Aortic Aneurysm Postoperative Renal Failure Stentgraft Complication

ClinConnect Summary

This clinical trial is studying how different types of stentgrafts used to treat an abdominal aortic aneurysm (AAA) affect kidney function. An abdominal aortic aneurysm is a bulge in the large artery (aorta) that supplies blood to the abdomen, pelvis, and legs. The researchers want to see if using stentgrafts that are fixed above or below the aneurysm makes a difference in how well the kidneys work after the procedure.

To participate in this trial, individuals must be between the ages of 65 and 74 and have been diagnosed with a non-ruptured abdominal or iliac aneurysm. They should be able to give their written permission to participate and have the right type of blood vessel structure for the treatment. However, those who are currently on dialysis or have other specific health conditions may not be eligible. Participants will undergo a procedure to repair their aneurysm, and the study will track their kidney function afterward. This trial is currently looking for volunteers, and it’s an important step in understanding how these treatments can affect overall health, particularly kidney health.

Gender

ALL

Eligibility 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.

About Vastra Gotaland Region

Vastra Gotaland Region is a prominent healthcare organization in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. As a sponsor, the region leverages its extensive network of hospitals and healthcare professionals to facilitate high-quality research initiatives that address pressing health challenges. With a commitment to ethical standards and patient safety, Vastra Gotaland Region strives to foster collaboration between researchers, clinicians, and patients, ensuring that clinical trials contribute valuable insights and advancements in medical science.

Locations

Gothenburg, , Sweden

Gothenburg, Vastragotaland, Sweden

Patients applied

0 patients applied

Trial Officials

Sophie Lindgren, M.D

Study Chair

Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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