QoL After Complex Endovascular Aortic Repair

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).

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Aortic Aneurysm, Abdominal; Aortic Aneurysm
• Intervention / Treatment: Procedure: Standard Endovascular aneurysm repair (sEVAR); Procedure: Complex Endovascular Aneurysm Repair (cEVAR)

Detailed Description

Prospective cohort study with patients planned for elective aortic endovascular repair during a two year time period. The estimated recruitment period is February 2023 - February 2025.

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.

The questionnaires to be filled out will be available online or by paper form. Patient- and aneurysm related variables will be recorded at the time of treatment decision. The endpoint is 3 years of follow up or death. Analysis will be done by both intention-to-treat and per protocol.

The questionnaires to be used are:

• SF-12
• EQ5D
• HADS
• Custom made questionnaire: Education, marital status and need for domestic service

The forms will be filled out at the following intervals:

• Preoperatively (<90 days prior to surgery).
• 30 days postoperatively.
• 6 months postoperatively.
• 12 months postoperatively.
• 36 months postoperatively.

The investigators aim to answer the following research questions:

• 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.
• To compare mental scores in SF-12 and HADS postoperatively compared to preoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR).
• To compare long-term mental scores and HADS-A and HADS-D postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) at one year and three years.
• To evaluate if a decreased function of physical and mental scores in EQ5D or SF-12 should be considered in a preoperative decision model by considering QALYs.
• To compare preoperative physical and mental scores by SF-12 and HADS-A / HADS-D between standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR).
• To compare preoperative and postoperative physical and mental scores by SF-12 and HADS-A / HADS-D between standard EVAR vs de-novo non-standard endovascular aortic repair (F-/BEVAR) vs F-/BEVAR in a previously treated EVAR patient.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Rebecka Hultgren, MD, PhD; Phone Number: +46 8 123 700 00; Email: rebecka.hultgren@ki.se
• Study Contact Backup: Name: Mårten Huss, MD; Phone Number: +46 8 123 700 00; Email: marten.huss@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Recruiting
    • Karolinska University Hospital
    • Contact: Mårten Huss, MD; Phone Number: +46 8 123 70000; Email: marten.huss@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard EVAR; Infrarenal abdominal aortic aneurysms treated with standard EVAR off-the-shelf devices.	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).
Complex EVAR; Paravisceral aortic aneurysms treated with fenestrated or branched EVAR devices.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late physical component score changes after standard or complex EVAR procedure.	To compare long-term physical scores postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) at one year.	2026
When does physical component scores return to normal after standard or complex EVAR procedures?	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.	2028

Collaborators and Investigators

• Sponsor: Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Endovascular aneurysm repair; Pararenal aortic aneurysm; Fenestrated endovascular aortic repair; Branched endovascular aortic repair; Paravisceral aortic aneurysm
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: QLEVER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No