Abdominal Aortic Aneurysm Without RuptureNCT04269447
Prospective Aortic Biobank of POP-STAR
An observational study of Abdominal Aortic Aneurysm Without Rupture and Abdominal Aortic Aneurysm, Ruptured, run by Karolinska University Hospital at 2 sites in Sweden.
Trial summary
The overall objective of the POP-STAR project is individualized surveillance for patients diagnosed with abdominal aortic aneurysms by means of more precise, patient-specific AAA growth prediction. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Abdominal Aortic Aneurysm Without Rupture, Abdominal Aortic Aneurysm, Ruptured, Aortic Aneurysm
- What is being tested?
- Structured imaging follow-up
- How many people
- 400 participants
- Where
- 2 sitesSweden
- Study dates
- 18 Nov 2019to Dec 2028
- How long will I take part?
- 5 Years
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All men and women diagnosed with an intact abdominal aortic aneurysm (AAA) and who fulfill the inclusion diameter criterion and none of the exclusion criteria are verified at the Department of Vascular Surgery, Karolinska University Hospital, Solna, and consecutively invited to participate.
Who may be able to join
- Abdominal aortic aneurysm 35-49 mm in men
- Abdominal aortic aneurysm 30-49 mm in women
Who cannot join
- Previous aortic or iliac surgery
- Present comorbidities with less than 2-years life expectancy
- Unable or unwilling to give informed consent
- Computed tomography examination with intravenous contrast contraindicated due to renal insufficiency (defined as creatinine/eGFR level XXX)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites
Department of Vascular Surgery, Karolinska University Hospital
Solna, Stockholm County, 171 76
Karolinska University Hospital
Stockholm, 17176
About this study
Official title: POP-STAR: The Prospective Data Collection on Patients With Abdominal Aortic Aneurysms at the Stockholm Aneurysm Research Group (STAR)
The overall objective of the POP-STAR project is individualized surveillance for patients diagnosed with abdominal aortic aneurysms by means of more precise, patient-specific AAA growth prediction.
Read the detailed description
Abdominal aortic aneurysms (AAA, ICD10 I71.4) are asymptomatic dilatations of the infrarenal aorta (≥3cm) with potential to rupture. This multifactorial disease is known to be caused by the progressive degradation of the aortic wall. AAAs have life-threatening consequences in the event of rupture (rAAA): the mortality is 100% if left untreated. The risk of rupture is closely related to the size of the AAA. When a patient is diagnosed with an AAA, life-long surveillance is initiated with regular ultrasound or computed tomography (CT) scans performed at vascular services. Prophylactic surgery is performed when the risk of rupture exceeds the risk of treatment: according to international guidelines, surgical evaluation and repair is indicated at a threshold of 55 mm (50 mm in women) to avoid rupture and subsequent death.
The mortality after planned, elective AAA repair is estimated at 1.5%. By contrast, the mortality after emergency surgery for rAAA reaches 30%. As such, there is much to be gained by early identification of AAAs to enable timely intervention and reduce aneurysm-related morbidity and mortality in the population. The important non-modifiable risk factors for developing the disease include male sex, smoking, high age and family history of AAA. Since 2006, one-time ultrasound screening for AAAs among elderly men has been gradually introduced in Sweden - the programme reached nationwide coverage in 2015. A prevalence of 1.4-2.0% has been recorded in the screened population and an overall reduction of 40% in aneurysm-related death has been demonstrated (annual decline in aneurysm-related mortality of 4%). It is not, however, cost-efficient to screen the female population due to low prevalence and high age at onset of disease.
Previous investigations have indicated that 10-25% of all patients admitted for rupture were already known by the health care system but were subsequently lost to follow-up. Importantly, some large aneurysms never rupture while some small aneurysms (<55 mm) unpredictably do so - in the randomized controlled trial of UKSAT, an annual rupture risk of 1% was documented for small AAAs.
Despite these shortcomings at a patient-specific level, there is still only one verified measure, the diameter, for evaluating growth, risk of rupture and indication for surgery. Consequently, the current follow-up protocol for AAA patients is generalized and fails to consider factors such as age, female sex, smoking, aneurysm morphology and lung function impairment. The major challenge within the field is risk assessment with high precision in order to provide treatment for the right patient and the right time.
The standard surveillance entails repeated diameter measurements: the larger the aneurysm, the shorter the control intervals. The POP-STAR project explores new methods of AAA surveillance by prospective data collection comprising of patient demographics, radiological properties and follow-up information on patients diagnosed with AAAs. All patients will be subjected to standard care flow - POP-STAR adds patient risk profiling and scheduled imaging follow-up. The goal is to be able to characterize the radiological and biomechanical profiles of AAAs for accurate risk stratification, ultimately aiming at individualized AAA patient care.
- Conditions
- Abdominal Aortic Aneurysm Without Rupture, Abdominal Aortic Aneurysm, Ruptured, Aortic Aneurysm, Aneurysm Abdominal, Aneurysm
- Being tested
- Structured imaging follow-up
- Keywords
- Growth Prediction, Rupture Risk Prediction, Imaging, Aortic disease, Vascular surgery, Vascular disease, Cardiovascular disease
- Medical subject headings
- Aortic Aneurysm, Abdominal, Rupture, Aortic Aneurysm, Aneurysm, Aortic Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured imaging follow-upDiagnostic test
Also called Finite element analysis (FEA)
Structured imaging follow-up protocol with ultrasound (US) and computed tomography (CT) examinations as compared to current standard surveillance protocol for individualized estimations of AAA growth.
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm expansion rate
Comparison of correctness of predicted growth (diameter vs ASI)
Measured: Primary outcome evaluated at two years of follow-up.
Aneurysm expansion rate
Assessment if a more correct predicted growth alters surveillance (ASI vs diameter)
Measured: Primary outcome second analysis at two years follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start18 Nov 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic Aneurysm Without RuptureStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
- Target duration
- 5 Years
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
- NCT04269447
- Sponsor's protocol ID
- EPN201904182
- Status last verified
- Apr 2025
- First submitted
- 5 Dec 2019
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
PubMed 29268916Wanhainen A, Hultgren R, Linne A, Holst J, Gottsater A, Langenskiold M, Smidfelt K, Bjorck M, Svensjo S; Swedish Aneurysm Screening Study Group (SASS). Outcome of the Swedish Nationwide Abdominal Aortic Aneurysm Screening Program. Circulation. 2016 Oct 18;134(16):1141-1148. doi: 10.1161/CIRCULATIONAHA.116.022305. Epub 2016 Sep 14.
PubMed 27630132Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available.
PubMed 30528142Sweeting MJ, Thompson SG, Brown LC, Powell JT; RESCAN collaborators. Meta-analysis of individual patient data to examine factors affecting growth and rupture of small abdominal aortic aneurysms. Br J Surg. 2012 May;99(5):655-65. doi: 10.1002/bjs.8707. Epub 2012 Mar 5.
PubMed 22389113Polzer S, Gasser TC, Vlachovsky R, Kubicek L, Lambert L, Man V, Novak K, Slazansky M, Bursa J, Staffa R. Biomechanical indices are more sensitive than diameter in predicting rupture of asymptomatic abdominal aortic aneurysms. J Vasc Surg. 2020 Feb;71(2):617-626.e6. doi: 10.1016/j.jvs.2019.03.051. Epub 2019 Jun 5.
PubMed 31176634Polzer S, Gasser TC. Biomechanical rupture risk assessment of abdominal aortic aneurysms based on a novel probabilistic rupture risk index. J R Soc Interface. 2015 Dec 6;12(113):20150852. doi: 10.1098/rsif.2015.0852.
PubMed 26631334Siika A, Lindquist Liljeqvist M, Zommorodi S, Nilsson O, Andersson P, Gasser TC, Roy J, Hultgren R. A large proportion of patients with small ruptured abdominal aortic aneurysms are women and have chronic obstructive pulmonary disease. PLoS One. 2019 May 28;14(5):e0216558. doi: 10.1371/journal.pone.0216558. eCollection 2019.
PubMed 31136570Zommorodi S, Roy J, Steuer J, Hultgren R. High proportion of known abdominal aortic aneurysm in patients with rupture indicates surveillance deficiency. J Vasc Surg. 2016 Oct;64(4):949-955.e1. doi: 10.1016/j.jvs.2016.04.007.
PubMed 27666443Brown LC, Thompson SG, Greenhalgh RM, Powell JT; UK Small Aneurysm Trial Participants. Fit patients with small abdominal aortic aneurysms (AAAs) do not benefit from early intervention. J Vasc Surg. 2008 Dec;48(6):1375-81. doi: 10.1016/j.jvs.2008.07.014.
PubMed 19118733Singh K, Bonaa KH, Jacobsen BK, Bjork L, Solberg S. Prevalence of and risk factors for abdominal aortic aneurysms in a population-based study : The Tromso Study. Am J Epidemiol. 2001 Aug 1;154(3):236-44. doi: 10.1093/aje/154.3.236.
PubMed 11479188Scott RA, Bridgewater SG, Ashton HA. Randomized clinical trial of screening for abdominal aortic aneurysm in women. Br J Surg. 2002 Mar;89(3):283-5. doi: 10.1046/j.0007-1323.2001.02014.x.
PubMed 11872050Sakalihasan N, Michel JB, Katsargyris A, Kuivaniemi H, Defraigne JO, Nchimi A, Powell JT, Yoshimura K, Hultgren R. Abdominal aortic aneurysms. Nat Rev Dis Primers. 2018 Oct 18;4(1):34. doi: 10.1038/s41572-018-0030-7.
PubMed 30337540
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POP-STAR: The Prospective Data Collection on Patients With Abdominal Aortic Aneurysms at the Stockholm Aneurysm Research Group (STAR)
- ClinicalTrials.gov ID
- NCT04269447
- Acronym / sponsor ID
- EPN201904182
- Conditions
- Abdominal Aortic Aneurysm Without Rupture, Abdominal Aortic Aneurysm, Ruptured, Aortic Aneurysm, Aneurysm Abdominal, Aneurysm
- Keywords
- Growth Prediction, Rupture Risk Prediction, Imaging, Aortic disease, Vascular surgery, Vascular disease, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Feb 2020 (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 overall objective of the POP-STAR project is individualized surveillance for patients diagnosed with abdominal aortic aneurysms by means of more precise, patient-specific AAA growth prediction.
Detailed description
Abdominal aortic aneurysms (AAA, ICD10 I71.4) are asymptomatic dilatations of the infrarenal aorta (≥3cm) with potential to rupture. This multifactorial disease is known to be caused by the progressive degradation of the aortic wall. AAAs have life-threatening consequences in the event of rupture (rAAA): the mortality is 100% if left untreated. The risk of rupture is closely related to the size of the AAA. When a patient is diagnosed with an AAA, life-long surveillance is initiated with regular ultrasound or computed tomography (CT) scans performed at vascular services. Prophylactic surgery is performed when the risk of rupture exceeds the risk of treatment: according to international guidelines, surgical evaluation and repair is indicated at a threshold of 55 mm (50 mm in women) to avoid rupture and subsequent death.
The mortality after planned, elective AAA repair is estimated at 1.5%. By contrast, the mortality after emergency surgery for rAAA reaches 30%. As such, there is much to be gained by early identification of AAAs to enable timely intervention and reduce aneurysm-related morbidity and mortality in the population. The important non-modifiable risk factors for developing the disease include male sex, smoking, high age and family history of AAA. Since 2006, one-time ultrasound screening for AAAs among elderly men has been gradually introduced in Sweden - the programme reached nationwide coverage in 2015. A prevalence of 1.4-2.0% has been recorded in the screened population and an overall reduction of 40% in aneurysm-related death has been demonstrated (annual decline in aneurysm-related mortality of 4%). It is not, however, cost-efficient to screen the female population due to low prevalence and high age at onset of disease.
Previous investigations have indicated that 10-25% of all patients admitted for rupture were already known by the health care system but were subsequently lost to follow-up. Importantly, some large aneurysms never rupture while some small aneurysms (<55 mm) unpredictably do so - in the randomized controlled trial of UKSAT, an annual rupture risk of 1% was documented for small AAAs.
Despite these shortcomings at a patient-specific level, there is still only one verified measure, the diameter, for evaluating growth, risk of rupture and indication for surgery. Consequently, the current follow-up protocol for AAA patients is generalized and fails to consider factors such as age, female sex, smoking, aneurysm morphology and lung function impairment. The major challenge within the field is risk assessment with high precision in order to provide treatment for the right patient and the right time.
The standard surveillance entails repeated diameter measurements: the larger the aneurysm, the shorter the control intervals. The POP-STAR project explores new methods of AAA surveillance by prospective data collection comprising of patient demographics, radiological properties and follow-up information on patients diagnosed with AAAs. All patients will be subjected to standard care flow - POP-STAR adds patient risk profiling and scheduled imaging follow-up. The goal is to be able to characterize the radiological and biomechanical profiles of AAAs for accurate risk stratification, ultimately aiming at individualized AAA patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All men and women diagnosed with an intact abdominal aortic aneurysm (AAA) and who fulfill the inclusion diameter criterion and none of the exclusion criteria are verified at the Department of Vascular Surgery, Karolinska University Hospital, Solna, and consecutively invited to participate.
Key inclusion criteria (2 listed)
- Abdominal aortic aneurysm 35-49 mm in men
- Abdominal aortic aneurysm 30-49 mm in women
Key exclusion criteria (4 listed)
- Previous aortic or iliac surgery
- Present comorbidities with less than 2-years life expectancy
- Unable or unwilling to give informed consent
- Computed tomography examination with intravenous contrast contraindicated due to renal insufficiency (defined as creatinine/eGFR level XXX)
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 |
|---|---|---|
| Structured imaging follow-upAlso: Finite element analysis (FEA)Structured imaging follow-up protocol with ultrasound (US) and computed tomography (CT) examinations as compared to current standard surveillance protocol for individualized estimations of AAA growth. | Diagnostic test | – |
Primary outcome
Aneurysm expansion rate
Time frame: Primary outcome evaluated at two years of follow-up.
Comparison of correctness of predicted growth (diameter vs ASI)
Aneurysm expansion rate
Time frame: Primary outcome second analysis at two years follow-up.
Assessment if a more correct predicted growth alters surveillance (ASI vs diameter)
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 8 Apr 2026.
- Background: PubMed 29268916Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
- Background: PubMed 27630132Wanhainen A, Hultgren R, Linne A, Holst J, Gottsater A, Langenskiold M, Smidfelt K, Bjorck M, Svensjo S; Swedish Aneurysm Screening Study Group (SASS). Outcome of the Swedish Nationwide Abdominal Aortic Aneurysm Screening Program. Circulation. 2016 Oct 18;134(16):1141-1148. doi: 10.1161/CIRCULATIONAHA.116.022305. Epub 2016 Sep 14.
- Background: PubMed 30528142Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available.
- Background: PubMed 22389113Sweeting MJ, Thompson SG, Brown LC, Powell JT; RESCAN collaborators. Meta-analysis of individual patient data to examine factors affecting growth and rupture of small abdominal aortic aneurysms. Br J Surg. 2012 May;99(5):655-65. doi: 10.1002/bjs.8707. Epub 2012 Mar 5.
- Background: PubMed 31176634Polzer S, Gasser TC, Vlachovsky R, Kubicek L, Lambert L, Man V, Novak K, Slazansky M, Bursa J, Staffa R. Biomechanical indices are more sensitive than diameter in predicting rupture of asymptomatic abdominal aortic aneurysms. J Vasc Surg. 2020 Feb;71(2):617-626.e6. doi: 10.1016/j.jvs.2019.03.051. Epub 2019 Jun 5.
- Background: PubMed 26631334Polzer S, Gasser TC. Biomechanical rupture risk assessment of abdominal aortic aneurysms based on a novel probabilistic rupture risk index. J R Soc Interface. 2015 Dec 6;12(113):20150852. doi: 10.1098/rsif.2015.0852.
- Background: PubMed 31136570Siika A, Lindquist Liljeqvist M, Zommorodi S, Nilsson O, Andersson P, Gasser TC, Roy J, Hultgren R. A large proportion of patients with small ruptured abdominal aortic aneurysms are women and have chronic obstructive pulmonary disease. PLoS One. 2019 May 28;14(5):e0216558. doi: 10.1371/journal.pone.0216558. eCollection 2019.
- Background: PubMed 27666443Zommorodi S, Roy J, Steuer J, Hultgren R. High proportion of known abdominal aortic aneurysm in patients with rupture indicates surveillance deficiency. J Vasc Surg. 2016 Oct;64(4):949-955.e1. doi: 10.1016/j.jvs.2016.04.007.
- Background: PubMed 19118733Brown LC, Thompson SG, Greenhalgh RM, Powell JT; UK Small Aneurysm Trial Participants. Fit patients with small abdominal aortic aneurysms (AAAs) do not benefit from early intervention. J Vasc Surg. 2008 Dec;48(6):1375-81. doi: 10.1016/j.jvs.2008.07.014.
- Background: PubMed 11479188Singh K, Bonaa KH, Jacobsen BK, Bjork L, Solberg S. Prevalence of and risk factors for abdominal aortic aneurysms in a population-based study : The Tromso Study. Am J Epidemiol. 2001 Aug 1;154(3):236-44. doi: 10.1093/aje/154.3.236.
- Background: PubMed 11872050Scott RA, Bridgewater SG, Ashton HA. Randomized clinical trial of screening for abdominal aortic aneurysm in women. Br J Surg. 2002 Mar;89(3):283-5. doi: 10.1046/j.0007-1323.2001.02014.x.
- Background: PubMed 30337540Sakalihasan N, Michel JB, Katsargyris A, Kuivaniemi H, Defraigne JO, Nchimi A, Powell JT, Yoshimura K, Hultgren R. Abdominal aortic aneurysms. Nat Rev Dis Primers. 2018 Oct 18;4(1):34. doi: 10.1038/s41572-018-0030-7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm Without Rupture and Abdominal Aortic Aneurysm, Ruptured, run by Karolinska University Hospital at 2 sites 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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneurysm expansion rate (time frame: Primary outcome evaluated at two years of follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04269447, which also lists 12 linked publications.
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 8 Apr 2026.