NCT04754659 Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm
| NCT ID | NCT04754659 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Aortic Aneurysm, Abdominal |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2022-12-19 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 252 participants in total. It began in 2022-12-19 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 fixation.
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.
Contact & Investigator
Sophie Lindgren, M.D
STUDY CHAIR
Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital
Frequently Asked Questions
Who can join the NCT04754659 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Aortic Aneurysm, Abdominal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04754659 currently recruiting?
Yes, NCT04754659 is actively recruiting participants. Contact the research team at per.skoog@vgregion.se for enrollment information.
Where is the NCT04754659 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT04754659 clinical trial?
NCT04754659 is sponsored by Vastra Gotaland Region. The principal investigator is Sophie Lindgren, M.D at Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital. The trial plans to enroll 252 participants.