NCT05774938 QoL After Complex Endovascular Aortic Repair
| NCT ID | NCT05774938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska University Hospital |
| Condition | Quality of Life |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-02-28 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2023-02-28 with a primary completion date of 2026-12.
⚠ 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
The goal of this prospective observational cohort study is to compare health related quality of life in patients with abdominal aortic aneurysms treated by either standard or complex EVAR (endovascular aneurysm repair) devices. The main questions it aims to answer are: * Compare differences between the physical scores from the preoperative to the postoperative settings between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) * To compare long-term physical scores postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) at one year. * To explore at which time points (if ever) patients treated with standard-EVAR and nonstandard endovascular aortic repair (F-/BEVAR) have restored or normalized physical scores measured by SF-12, measured at 30 days, 6 months, 1 and 3 years. Participants will be asked to fill out forms pre- and postoperatively with regards to health related quality of life. The different groups for comparison will be either standard EVAR for infrarenal aortic aneurysms or complex EVAR (fenestrated or branched) for paravisceral aortic aneurysms (PVAAA).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05774938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Quality of Life. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05774938 currently recruiting?
Yes, NCT05774938 is actively recruiting participants. Contact the research team at rebecka.hultgren@ki.se for enrollment information.
Where is the NCT05774938 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05774938 clinical trial?
NCT05774938 is sponsored by Karolinska University Hospital. The trial plans to enroll 90 participants.