Quality of LifeNCT05774938
QoL After Complex Endovascular Aortic Repair
An observational study of Quality of Life and Aortic Aneurysm, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Aortic Aneurysm, Aortic Aneurysm, Abdominal
- What is being tested?
- Standard Endovascular aneurysm repair (sEVAR) and Complex Endovascular Aneurysm Repair (cEVAR)
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 28 Feb 2023to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17176
Mårten Huss, MD, +46 8 123 70000, marten.huss@ki.se
About this study
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.
Read more
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).
Read the 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
- Being tested
- Standard Endovascular aneurysm repair (sEVAR), Complex Endovascular Aneurysm Repair (cEVAR)
- Keywords
- Endovascular aneurysm repair, Pararenal aortic aneurysm, Quality of life, Paravisceral aortic aneurysm, Fenestrated endovascular aortic repair, Branched endovascular aortic repair
- Medical subject headings
- Aortic Aneurysm, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Endovascular aneurysm repair (sEVAR)Procedure or surgery
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)Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Standard EVAR | Infrarenal abdominal aortic aneurysms treated with standard EVAR off-the-shelf devices. Receives: Procedure: Standard Endovascular aneurysm repair (sEVAR) | |
| Complex EVAR | Paravisceral aortic aneurysms treated with fenestrated or branched EVAR devices. Receives: Procedure: Complex Endovascular Aneurysm Repair (cEVAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2026
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start28 Feb 2023
- Primary completionDec 2026 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecka Hultgren, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774938
- Sponsor's protocol ID
- QLEVER
- Status last verified
- Apr 2025
- First submitted
- 7 Mar 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QoL After Complex Endovascular Aortic Repair
- ClinicalTrials.gov ID
- NCT05774938
- Acronym / sponsor ID
- QLEVER
- Conditions
- Quality of Life, Aortic Aneurysm, Aortic Aneurysm, Abdominal
- Keywords
- Endovascular aneurysm repair, Pararenal aortic aneurysm, Quality of life, Paravisceral aortic aneurysm, Fenestrated endovascular aortic repair, Branched endovascular aortic repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard EVAR | – | Procedure: Standard Endovascular aneurysm repair (sEVAR)Infrarenal abdominal aortic aneurysms treated with standard EVAR off-the-shelf devices. |
| Complex EVAR | – | Procedure: Complex Endovascular Aneurysm Repair (cEVAR)Paravisceral aortic aneurysms treated with fenestrated or branched EVAR devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Standard EVAR |
| 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). | Procedure or surgery | Complex EVAR |
Primary outcome
Early physical component score changes after standard or complex EVAR procedure.
Time frame: 2026
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.
2 secondary outcomes
Late physical component score changes after standard or complex EVAR procedure.
Time frame: 2026
When does physical component scores return to normal after standard or complex EVAR procedures?
Time frame: 2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Aortic Aneurysm, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecka Hultgren, MD, PhD (+46 8 123 700 00, rebecka.hultgren@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early physical component score changes after standard or complex EVAR procedure. (time frame: 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.