QoL After Complex Endovascular Aortic Repair

NCT05774938 | Recruiting

• 1 other identifier: QLEVER
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Quality of Life; Aortic Aneurysm; Aortic Aneurysm, Abdominal

Keywords

Endovascular aneurysm repair; Pararenal aortic aneurysm; Quality of life; Paravisceral aortic aneurysm; Fenestrated endovascular aortic repair; Branched endovascular aortic repair

Outcome Measures

Primary Outcomes (1)

• Early physical component score changes after standard or complex EVAR procedure.

  To compare the difference 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) at 30 days.

  2026

Secondary Outcomes (2)

• Late physical component score changes after standard or complex EVAR procedure.

  2026

• When does physical component scores return to normal after standard or complex EVAR procedures?

  2028

Study Arms (2)

Standard EVAR

Infrarenal abdominal aortic aneurysms treated with standard EVAR off-the-shelf devices.

Procedure: Standard Endovascular aneurysm repair (sEVAR)

Complex EVAR

Paravisceral aortic aneurysms treated with fenestrated or branched EVAR devices.

Procedure: Complex Endovascular Aneurysm Repair (cEVAR)

Interventions

Standard Endovascular aneurysm repair (sEVAR) PROCEDURE

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).

Standard EVAR

Complex Endovascular Aneurysm Repair (cEVAR) PROCEDURE

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).

Complex EVAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with infrarenal or paravisceral aortic aneurysms planned for treatment with EVAR or F-/BEVAR will be invited to participate in the study at the time of consent of the proposed treatment

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.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Rebecka Hultgren, MD, PhD

CONTACT

+46 8 123 700 00; rebecka.hultgren@ki.se

Mårten Huss, MD

CONTACT

+46 8 123 700 00; marten.huss@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: February 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

SE (1)