QoL After Complex Endovascular Aortic Repair

Quality of Life Clinical Trial

Official title:

QoL After Complex Endovascular Aortic Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774938
• Other study ID #: QLEVER
• Status: Recruiting
• Start date: February 28, 2023
• Est. completion date: January 2030

Study information

• Verified date: March 2023
• Source: Karolinska University Hospital
• Contact: Rebecka Hultgren, MD, PhD
• Phone: +46 8 123 700 00
• Email: rebecka.hultgren[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 question 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-stnadard 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).

Description:

Prospective cohort study with patients planned for elective aortic endovascular repair during a twoyear 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 aneurysmrelated 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.

We 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-stnadard 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 decicion 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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 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).

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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