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

Study Overview
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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.

Official Title
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EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)- A Randomized Controlled Multicentre Study in Germany

Conditions
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Abdominal Aortic Aneurysm, Endoleak

Intervention / Treatment
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* Procedure: Coil embolization of aneurysm sac


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVAR with SE<br>Patients in the EVAR-SE arm will receive EVAR with additional coil embolization of the aneurysm sac. | Procedure: Coil embolization of aneurysm sac<br>* Patients are treated with standard EVAR with additional coiling of the aneurysm sac. The distinct type of coils used is not predefined.<br>|
| No Intervention: standard EVAR<br>Patients in the standard EVAR arm will receive EVAR without additional coil embolization of the aneurysm sac. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type II Endoleak during follow up | T2EL 2-4 days after EVAR treatment detected by CEUS and/or CT-A | 2-4 days | 
| Type II Endoleak during follow up | T2EL 30 days after EVAR treatment detected by CEUS and/or CT-A | 30 days | 
| Type II Endoleak during follow up | T2EL 6 months after EVAR treatment detected by CEUS and/or CT-A | 6 months | 
| Re-intervention | Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration) | 12 months | 
| Type I or III Endoleak | Occurrence of any EL Type I or III | 12 months | 
| AAA morphology | Changes of AAA diameter as measured by CT-A in comparison to initial CT-A scan at V0 | 12 months | 
| AAA morphology | Changes of AAA volume as measured by CT-A in comparison to initial CT-A scan at V0 | 12 months | 
| AAA rupture | Rate of AAA rupture 12 months after EVAR treatment | 12 months | 
| Mortality | Mortality (aneurysm-related/not aneurysm related) 12 months after EVAR treatment | 12 months | 
| life quality | Change in quality of life assessed by SF-36 from baseline to 12 months after EVAR treat-ment | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal Aortic Aneurysm, Endoleak, Endovascular aortic aneurysm repair, Coiling, Endoleak Type II