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

Christoph Knappich

Status: Enrolling

Conditions: Endoleak; Abdominal Aortic Aneurysm

Treatments: Procedure: Coil embolization of aneurysm sac

Study type: Interventional

Funder types: Other

Identifiers

NCT05665101

V1.1

01KG2128 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

EVAR with SE

Experimental group

Description:

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

Treatment:

Procedure: Coil embolization of aneurysm sac

standard EVAR

No Intervention group

Description:

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