Abdominal Aortic AneurysmEVAR-SENCT05665101
EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)
A study testing Coil embolization of aneurysm sac in people with Abdominal Aortic Aneurysm and Endoleak, run by Univ.-Prof. Dr. Dr. med. Daniela Branzan at 1 site in Germany.
Trial summary
Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Endoleak
- What is being tested?
- Coil embolization of aneurysm sac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2023to 31 Aug 2028
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years
- Infrarenal AAA ≥50 mm maximum diameter
- Indication for EVAR within IFU of company
- Presence of one or both high risk criteria on CT-A: ≥5 patent efferent vessels (inferior mesenteric and/or lumbar artery, and/or median sacral artery) or <40% thrombus at largest AAA diameter
Who cannot join
- Ruptured AAA
- Fenestrated or branched EVAR
- Concomitant iliac artery aneurysm
- Non-ability to adhere to the FU protocol
- Lack of consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
Munich, Bavaria, 81675
About this study
Official title: EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)- A Randomized Controlled Multicentre Study in Germany
Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture.
Secondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.
- Conditions
- Abdominal Aortic Aneurysm, Endoleak
- Being tested
- Coil embolization of aneurysm sac
- Keywords
- Abdominal Aortic Aneurysm, Endoleak, Endovascular aortic aneurysm repair, Coiling, Endoleak Type II
- Medical subject headings
- Aortic Aneurysm, Abdominal, Endoleak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coil embolization of aneurysm sacProcedure or surgery
Patients are treated with standard EVAR with additional coiling of the aneurysm sac. The distinct type of coils used is not predefined.
| Study group | Role | What they receive |
|---|---|---|
| EVAR with SE | Experimental | Patients in the EVAR-SE arm will receive EVAR with additional coil embolization of the aneurysm sac. Receives: Procedure: Coil embolization of aneurysm sac |
| standard EVAR | No intervention | Patients in the standard EVAR arm will receive EVAR without additional coil embolization of the aneurysm sac. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type II Endoleak at 12 months after procedure
Evaluation of the T2EL proportion of the intervention group as compared to the control group at 12 months after EVAR treatment as measured by CEUS and/or CT-A
Measured: 12 months
Secondary outcomes (10)
Type II Endoleak during follow up
T2EL 2-4 days after EVAR treatment detected by CEUS and/or CT-A
Measured: 2-4 days
Type II Endoleak during follow up
T2EL 30 days after EVAR treatment detected by CEUS and/or CT-A
Measured: 30 days
Type II Endoleak during follow up
T2EL 6 months after EVAR treatment detected by CEUS and/or CT-A
Measured: 6 months
Re-intervention
Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration)
Measured: 12 months
Type I or III Endoleak
Occurrence of any EL Type I or III
Measured: 12 months
AAA morphology
Changes of AAA diameter as measured by CT-A in comparison to initial CT-A scan at V0
Measured: 12 months
AAA morphology
Changes of AAA volume as measured by CT-A in comparison to initial CT-A scan at V0
Measured: 12 months
AAA rupture
Rate of AAA rupture 12 months after EVAR treatment
Measured: 12 months
Mortality
Mortality (aneurysm-related/not aneurysm related) 12 months after EVAR treatment
Measured: 12 months
life quality
Change in quality of life assessed by SF-36 from baseline to 12 months after EVAR treat-ment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start15 Jan 2023
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Univ.-Prof. Dr. Dr. med. Daniela Branzan
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, St. Josefs-Hospital Wiesbaden GmbH, University Hospital Augsburg, University Hospital Carl Gustav Carus
- Responsible party
- Sponsor-investigator, Univ.-Prof. Dr. Dr. med. Daniela Branzan, Technical University of Munich
- Investigators
- Daniela Branzan, Univ.-Prof. Dr. Dr. med., Principal investigator, Technical University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665101
- Sponsor's protocol ID
- V1.1
- Other IDs
- 01KG2128
- Acronym
- EVAR-SE
- Status last verified
- Aug 2026
- First submitted
- 7 Dec 2022
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knappich C, Kirchhoff F, Fritsche MK, Egert-Schwender S, Wendorff H, Kallmayer M, Haller B, Hyhlik-Duerr A, Reeps C, Eckstein HH, Trenner M. Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany. Trials. 2024 Jan 2;25(1):17. doi: 10.1186/s13063-023-07888-8.
PubMed 38167068
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)- A Randomized Controlled Multicentre Study in Germany
- ClinicalTrials.gov ID
- NCT05665101
- Acronym / sponsor ID
- EVAR-SE / V1.1
- Conditions
- Abdominal Aortic Aneurysm, Endoleak
- Keywords
- Abdominal Aortic Aneurysm, Endoleak, Endovascular aortic aneurysm repair, Coiling, Endoleak Type II
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Univ.-Prof. Dr. Dr. med. Daniela BranzanUniversity, hospital or other
- Collaborators
- Technical University of Munich, St. Josefs-Hospital Wiesbaden GmbH, University Hospital Augsburg, University Hospital Carl Gustav Carus
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 27 Dec 2022 (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.
Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture.
Secondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| EVAR with SE | Experimental | Procedure: Coil embolization of aneurysm sacPatients in the EVAR-SE arm will receive EVAR with additional coil embolization of the aneurysm sac. |
| standard EVAR | No intervention | –Patients in the standard EVAR arm will receive EVAR without additional coil embolization of the aneurysm sac. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Infrarenal AAA ≥50 mm maximum diameter
- Indication for EVAR within IFU of company
- Presence of one or both high risk criteria on CT-A: ≥5 patent efferent vessels (inferior mesenteric and/or lumbar artery, and/or median sacral artery) or <40% thrombus at largest AAA diameter
Key exclusion criteria (6 listed)
- Ruptured AAA
- Fenestrated or branched EVAR
- Concomitant iliac artery aneurysm
- Non-ability to adhere to the FU protocol
- Lack of consent
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 |
|---|---|---|
| Coil embolization of aneurysm sacPatients are treated with standard EVAR with additional coiling of the aneurysm sac. The distinct type of coils used is not predefined. | Procedure or surgery | EVAR with SE |
Primary outcome
Type II Endoleak at 12 months after procedure
Time frame: 12 months
Evaluation of the T2EL proportion of the intervention group as compared to the control group at 12 months after EVAR treatment as measured by CEUS and/or CT-A
10 secondary outcomes
Type II Endoleak during follow up
Time frame: 2-4 days
Type II Endoleak during follow up
Time frame: 30 days
Type II Endoleak during follow up
Time frame: 6 months
Re-intervention
Time frame: 12 months
Type I or III Endoleak
Time frame: 12 months
AAA morphology
Time frame: 12 months
AAA morphology
Time frame: 12 months
AAA rupture
Time frame: 12 months
Mortality
Time frame: 12 months
life quality
Time frame: 12 months
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 31 Aug 2026.
- Derived from this study: PubMed 38167068Knappich C, Kirchhoff F, Fritsche MK, Egert-Schwender S, Wendorff H, Kallmayer M, Haller B, Hyhlik-Duerr A, Reeps C, Eckstein HH, Trenner M. Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany. Trials. 2024 Jan 2;25(1):17. doi: 10.1186/s13063-023-07888-8.
- 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. This study is not recruiting at the moment.
Daniela Branzan, Univ.-Prof. Dr. Dr. med. principal investigator
Technical University Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coil embolization of aneurysm sac in people with Abdominal Aortic Aneurysm and Endoleak, run by Univ.-Prof. Dr. Dr. med. Daniela Branzan at 1 site in Germany.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. 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 Germany. 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?
Type II Endoleak at 12 months after procedure (time frame: 12 months). 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 NCT05665101, which also lists 1 linked publication.
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 31 Aug 2026.