NCT05665101

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

December 7, 2022

Last Update Submit

September 24, 2025

Conditions

Abdominal Aortic AneurysmEndoleak

Keywords

Abdominal Aortic AneurysmEndoleakEndovascular aortic aneurysm repairCoilingEndoleak Type II

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Type II Endoleak during follow up

    2-4 days

  • Type II Endoleak during follow up

    30 days

  • Type II Endoleak during follow up

    6 months

  • Re-intervention

    12 months

  • Type I or III Endoleak

    12 months

  • +5 more secondary outcomes

Study Arms (2)

EVAR with SE

EXPERIMENTAL

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

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.

Interventions

Coil embolization of aneurysm sacPROCEDURE

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

EVAR with SE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie

Munich, Bavaria, 81675, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38167068DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalEndoleak

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesPostoperative HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • Christoph Knappich, PD Dr. med.

    Technical University Munich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Knappich, PD Dr. med.

CONTACT

0049-894140christoph.knappich@mri.tum.de

Marie Kristin Fritsche, Dr. rer. nat.

CONTACT

0046-894140mariekristin.fritsche@mri.tum.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 27, 2022

Study Start

January 15, 2023

Primary Completion

October 31, 2025

Study Completion

April 30, 2026

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)