QoL After Complex Endovascular Aortic Repair
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard Endovascular aneurysm repair (sEVAR)
Procedure/SurgeryStandard 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)
Procedure/SurgeryComplex 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).
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Standard EVAR1 intervention
Group B: Complex EVAR1 intervention
Trial outcomes
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.
Time frame
2026Secondary outcomes
1
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.
Time frame
20262
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.
Time frame
2028Sponsors and contacts
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Source ClinicalTrials.gov