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

Not Applicable

Recruiting

• Conditions: Abdominal Aortic Aneurysm; Endoleak
• Interventions: Procedure: Coil embolization of aneurysm sac

• Registration Number: NCT05665101
• Lead Sponsor: Univ.-Prof. Dr. med. Hans-Henning Eckstein

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-27
• Study Start: 2023-01-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12
• Primary Completion: 2025-10-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Type II Endoleak at 12 months after procedure	12 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Klinikum rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie; 🇩🇪 Munich, Bayern, Germany