NCT05774938

QoL After Complex Endovascular Aortic Repair

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-02-28
• Primary completion: 2026-12-01
• Completion: 2030-01-01
• First posted: 2023-03-20
• Last updated: 2025-04-10

Locations

1 site across 1 country: Sweden