Endurant Stent Graft Natural Selection Global Postmarket Registry

Study Overview
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Brief Summary
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The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

Detailed Description
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The Endurant Stent Graft Natural Selection Global Post-market Registry, ENGAGE is initiated to expand the clinical knowledge base by including 'real world' subjects, applying a minimal amount of subject selection criteria. This subject group may better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases. ENGAGE aims at following and documenting the subject selections, diagnostic tools used and treatment interventions chosen by the vascular surgeon or interventional radiologist. ENGAGE will not impose CIP required study procedures affecting clinical practice.

Official Title
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Endurant Stent Graft Natural Selection Global Postmarket Registry

Conditions
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Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Device: Endurant Stent Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years or minimum age as required by local regulations Indication for elective surgical repair of AAA with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System Signed consent form (Patient informed consent Form or Patient Data Release Authorization Form). The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information Intention to electively implant the ENDURANT Stent Graft System Ability and willingness to comply with the CIP. Exclusion Criteria: High probability of non-adherence to physician's follow-up requirements Current participation in a concurrent trial which may confound study results

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AAA patients<br>Subjects diagnosed with an AAA who are considered candidates for endovascular repair with Endurant Stent Graft, and who meet the inclusion/exclusion criteria are intended to participate in this registry | Device: Endurant Stent Graft<br>* Endurant Stent Graft implantation<br>* Other names: EVAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Graft Migration |  | 10 years | 
| Stent Graft Patency |  | 10 years | 
| Stent Graft Endoleaks |  | 10 years | 
| Secondary procedures to correct Type I and III endoleaks |  | 10 years | 
| Secondary endovascular procedure |  | 10 years | 
| Adverse Device Effects |  | 10 years | 
| Technical Observations |  | 5 years | 
| Aneurysm-related mortality |  | 10 years | 
| All-cause mortality |  | 10 years | 
| MAE |  | 30 days | 
| Health Related Quality of Life Scores |  | 12 months | 
| Stent Graft Stenosis | Stent Graft stenosis is considered a reduction in the diameter of the stent graft lumen as compared to the reference. SG stenosis will be assessed by imaging as CT with contrast, Ultrasound, etc. | 10 years | 
| AAA Diameter Increase |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endurant, Stent Graft, Abdominal Aortic Aneurysm