Comparing quality of life after different types of aortic aneurysm repair
QoL After Complex Endovascular Aortic Repair
This study looks at how different types of surgery for abdominal aortic aneurysms affect the quality of life for patients over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05774938 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate health-related quality of life in patients with abdominal aortic aneurysms treated with either standard or complex endovascular aneurysm repair (EVAR) devices. Participants will complete questionnaires assessing their quality of life before and after the procedure at various intervals over three years. The study will compare physical health scores between the two treatment groups to determine the impact of the type of repair on long-term quality of life outcomes.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 and older who are scheduled for elective endovascular treatment of infrarenal or paravisceral aortic aneurysms.
Not a fit: Patients who cannot understand or respond to the study questionnaires in Swedish or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which treatment method offers better quality of life outcomes for patients with abdominal aortic aneurysms.
How similar studies have performed: While similar studies have explored quality of life post-aortic repair, this specific comparison between standard and complex EVAR is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women. * Any age (≥18 years) * Planned (elective) endovascular treatment by EVAR, FEVAR or BEVAR. * Patients previously treated by EVAR which are planned for an adjunct fenestrated cuff will not be included in the basic analysis, but included and analysed separately. Exclusion Criteria: * Inability to understand and/or respond to the study questionnaires that are in Swedish. * Inability to provide an informed consent for participation in the study, orally or in writing (This may be due to linguistic or cognitive limitation). * Participation in other ongoing studies concerning quality of life.
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Rebecka Hultgren, MD, PhD
- Email: rebecka.hultgren@ki.se
- Phone: +46 8 123 700 00
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.