QoL After Complex Endovascular Aortic Repair

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Rebecka Hultgren, MD, PhD
rebecka.hultgren@ki.se
+46 8 123 700 00
Backup
Mårten Huss, MD
marten.huss@ki.se
+46 8 123 700 00
Time Frame
Start Date: 2023-02-28
Estimated Completion Date: 2030-01
Participants
Target number of participants: 90
Treatments
Standard EVAR
Infrarenal abdominal aortic aneurysms treated with standard EVAR off-the-shelf devices.
Complex EVAR
Paravisceral aortic aneurysms treated with fenestrated or branched EVAR devices.
Sponsors
Leads: Karolinska University Hospital

This content was sourced from clinicaltrials.gov