QoL After Complex Endovascular Aortic Repair

Recruiting now

Conditions studied: Quality of Life, Aortic Aneurysm, Aortic Aneurysm, Abdominal

In brief

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).

Key facts

Study ID

NCT05774938

Run by

Karolinska University Hospital

People needed

90

Starts

2023-02-28

Expected to finish

2030-01-01

Last updated by the study team

2025-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Karolinska University Hospital — Stockholm, Sweden (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.