EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)

Sponsor

Univ.-Prof. Dr. med. Hans-Henning Eckstein (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05665101

Collaborator

Technical University of Munich (Other), St. Josefs-Hospital Wiesbaden GmbH (Other), University Hospital Augsburg (Other), University Hospital Carl Gustav Carus (Other)

100

Enrollment

Arms

39.9

Anticipated Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm Endoleak	Procedure: Coil embolization of aneurysm sac	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized controlledrandomized controlled

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Apr 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EVAR with SE Patients in the EVAR-SE arm will receive EVAR with additional coil embolization of the aneurysm sac.	Procedure: Coil embolization of aneurysm sac Patients are treated with standard EVAR with additional coiling of the aneurysm sac. The distinct type of coils used is not predefined.
No Intervention: standard EVAR Patients in the standard EVAR arm will receive EVAR without additional coil embolization of the aneurysm sac.

Arm

Intervention/Treatment

Experimental: EVAR with SE

Patients in the EVAR-SE arm will receive EVAR with additional coil embolization of the aneurysm sac.

Procedure: Coil embolization of aneurysm sac

Patients are treated with standard EVAR with additional coiling of the aneurysm sac. The distinct type of coils used is not predefined.

No Intervention: standard EVAR

Patients in the standard EVAR arm will receive EVAR without additional coil embolization of the aneurysm sac.

Outcome Measures

Primary Outcome Measures

Type II Endoleak at 12 months after procedure [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

Secondary Outcome Measures

Type II Endoleak during follow up [2-4 days]
T2EL 2-4 days after EVAR treatment detected by CEUS and/or CT-A
Type II Endoleak during follow up [30 days]
T2EL 30 days after EVAR treatment detected by CEUS and/or CT-A
Type II Endoleak during follow up [6 months]
T2EL 6 months after EVAR treatment detected by CEUS and/or CT-A
Re-intervention [12 months]
Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration)
Type I or III Endoleak [12 months]
Occurrence of any EL Type I or III
AAA morphology [12 months]
Changes of AAA diameter as measured by CT-A in comparison to initial CT-A scan at V0
AAA morphology [12 months]
Changes of AAA volume as measured by CT-A in comparison to initial CT-A scan at V0
AAA rupture [12 months]
Rate of AAA rupture 12 months after EVAR treatment
Mortality [12 months]
Mortality (aneurysm-related/not aneurysm related) 12 months after EVAR treatment
life quality [12 months]
Change in quality of life assessed by SF-36 from baseline to 12 months after EVAR treat-ment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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