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Recruiting NCT05665101

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

No phase Interventional Abdominal Aortic Aneurysm Endoleak

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coil embolization of aneurysm sac.
Who it may be relevant to
Registry conditions: Abdominal Aortic Aneurysm, Endoleak. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Type II Endoleak at 12 months after procedure [Time frame: 12 months]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Germany · 1 center
  • TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirur — Munich

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. PMID 38167068

Identifiers

NCT: NCT05665101 · V1.1 · 01KG2128

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗