Aortic Aneurysm, Abdominal
Conditions
Keywords
Endurant, Stent Graft, Abdominal Aortic Aneurysm
Brief summary
The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.
Detailed description
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.
Interventions
DEVICEEndurant Stent Graft
Endurant Stent Graft implantation
Sponsors
Medtronic Cardiovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Success | 10 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Stent Graft Migration | 10 years | — |
| All-cause mortality | 10 years | — |
| MAE | 30 days | — |
| Health Related Quality of Life Scores | 12 months | — |
| Stent Graft Stenosis | 10 years | 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. |
| AAA Diameter Increase | 10 years | — |
| Aneurysm-related mortality | 10 years | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czechia, France, Germany, Greece, Hong Kong, Israel, Italy, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey (Türkiye), United Kingdom, Uruguay
Outcome results
None listed