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

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm; Endoleak
• Intervention / Treatment: Procedure: Coil embolization of aneurysm sac

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela Branzan, Univ.-Prof. Dr. Dr. med.; Phone Number: 2167 0049-894140; Email: gefaesschirurgie@mri.tum.de
• Study Contact Backup: Name: Marie Kristin Fritsche, Dr. rer. nat.; Phone Number: 6054 0046-894140; Email: evarse.gc@mri.tum.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Recruiting
      • TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
      • Sub-Investigator: Felix Kirchhoff, Dr. med.
      • Contact: Daniela Branzan, Univ.-Prof.Dr.med.; Phone Number: 2167 0049894140; Email: gefaesschirurgie@mri.tum.de
      • Contact: Marie Kristin Fritsche, Dr. rer. nat.; Phone Number: 6054 0049894140; Email: evarse.gc@mri.tum.de
      • Principal Investigator: Daniela Branzan, Univ.-Prof. Dr. Dr. med.
      • Sub-Investigator: Melad Abu Jiries, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

• Ruptured AAA
• Fenestrated or branched EVAR
• Concomitant iliac artery aneurysm
• Non-ability to adhere to the FU protocol
• Lack of consent
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Univ.-Prof. Dr. Dr. med. Daniela Branzan
• Collaborators: Technical University of Munich; St. Josefs-Hospital Wiesbaden GmbH; University Hospital Augsburg; University Hospital Carl Gustav Carus
• Investigators: Principal Investigator: Daniela Branzan, Univ.-Prof. Dr. Dr. med., Technical University Munich

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Abdominal Aortic Aneurysm; Coiling; Endoleak; Endovascular aortic aneurysm repair; Endoleak Type II
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Hemorrhage; Aortic Diseases; Aneurysm; Aortic Aneurysm; Postoperative Hemorrhage; Pathological Conditions, Signs and Symptoms; Aortic Aneurysm, Abdominal; Endoleak
• Other Study ID Numbers: V1.1; 01KG2128 (Other Grant/Funding Number: Bundesministerium für Bildung und Forschung)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No