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QoL After Complex Endovascular Aortic Repair

NCT05774938 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2025-04-10

No results posted yet for this study

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).

Conditions

  • Quality of Life
  • Aortic Aneurysm
  • Aortic Aneurysm, Abdominal

Interventions

PROCEDURE

Standard Endovascular aneurysm repair (sEVAR)

Standard EVAR treatment with Medtronic Endurant IIs (Medtronic, Inc. - Minneapolis, Minnesota), Gore Excluder AAA (W. L. Gore \& Associates, Inc. - Newark, Delaware), Gore Excluder Conformable AAA (W. L. Gore \& Associates, Inc. - Newark, Delaware), Cook Zenith Flex (Cook Medical, Inc. - Bloomington, Indiana).

PROCEDURE

Complex Endovascular Aneurysm Repair (cEVAR)

Complex EVAR treatment with custom made devices (CMD's) from Cook Medical (Cook Medical, Inc. - Bloomington, Indiana) including fenestrated or branched devices or off-the-shelf T-branch device (Cook Medical, Inc. - Bloomington, Indiana).

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2026-12-31
Completion
2030-01-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05774938 on ClinicalTrials.gov