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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Abdominal Aortic Aneurysm Endoleak

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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EVAR with SE

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

Group Type EXPERIMENTAL

Coil embolization of aneurysm sac

Intervention Type PROCEDURE

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

standard EVAR

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No