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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:
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).
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:
The forms will be filled out at the following intervals:
The investigators aim to answer the following research questions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard EVAR | Infrarenal abdominal aortic aneurysms treated with standard EVAR off-the-shelf devices. |
| |
| Complex EVAR | Paravisceral aortic aneurysms treated with fenestrated or branched EVAR devices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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? |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecka Hultgren, MD, PhD | Contact | +46 8 123 700 00 | rebecka.hultgren@ki.se | |
| MÃ¥rten Huss, MD | Contact | +46 8 123 700 00 | marten.huss@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 17176 | Sweden |
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| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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|
| 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). |
|
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 |