RecruitingNCT05774938

QoL After Complex Endovascular Aortic Repair

Sponsor

Karolinska University Hospital

Enrollment

90 participants

Start Date

Feb 28, 2023

Study Type

OBSERVATIONAL

Conditions

Quality of Life Aortic Aneurysm Aortic Aneurysm, Abdominal

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria3

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.

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Interventions

PROCEDUREStandard 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).

PROCEDUREComplex 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).