An interventional study of Coil embolization of aneurysm sac in Abdominal Aortic Aneurysm and Endoleak, sponsored by Univ.-Prof. Dr. Dr. med. Daniela Branzan. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Univ.-Prof. Dr. Dr. med. Daniela Branzan · Not applicable, Interventional, and Prevention
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.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's enrollment of 101 is above the median of 66 across 228 interventional studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →This is the only study on the registry with Univ.-Prof. Dr. Dr. med. Daniela Branzan as lead sponsor.
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Exclusion Criteria:
Patients in the EVAR-SE arm will receive EVAR with additional coil embolization of the aneurysm sac.
Procedure: Coil embolization of aneurysm sac
Patients in the standard EVAR arm will receive EVAR without additional coil embolization of the aneurysm sac.
Patients are treated with standard EVAR with additional coiling of the aneurysm sac. The distinct type of coils used is not predefined.
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
Time frame: 12 months
Type II Endoleak during follow up
T2EL 2-4 days after EVAR treatment detected by CEUS and/or CT-A
Time frame: 2-4 days
Type II Endoleak during follow up
T2EL 30 days after EVAR treatment detected by CEUS and/or CT-A
Time frame: 30 days
Type II Endoleak during follow up
T2EL 6 months after EVAR treatment detected by CEUS and/or CT-A
Time frame: 6 months
Re-intervention
Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration)
Time frame: 12 months
Type I or III Endoleak
Occurrence of any EL Type I or III
Time frame: 12 months
AAA morphology
Changes of AAA diameter as measured by CT-A in comparison to initial CT-A scan at V0
Time frame: 12 months
AAA morphology
Changes of AAA volume as measured by CT-A in comparison to initial CT-A scan at V0
Time frame: 12 months
AAA rupture
Rate of AAA rupture 12 months after EVAR treatment
Time frame: 12 months
Mortality
Mortality (aneurysm-related/not aneurysm related) 12 months after EVAR treatment
Time frame: 12 months
life quality
Change in quality of life assessed by SF-36 from baseline to 12 months after EVAR treat-ment
Time frame: 12 months
Plan to share: No
Started Jan 2023 (actual). Primary completion is estimated for Aug 2028, 67 months after the start.
Of 51 non-industry interventional studies with no phase under Aortic Aneurysm, Abdominal, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 61. This study's planned 67 months is above that.
Counting every sponsor, half of 94 studies reached it within 43 months; a quarter within 23 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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