The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.
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.
Study Type
OBSERVATIONAL
Enrollment
1,266
Endurant Stent Graft implantation
Treatment Success
Time frame: 10 years
Stent Graft Migration
Time frame: 10 years
Stent Graft Patency
Time frame: 10 years
Stent Graft Endoleaks
Time frame: 10 years
Secondary procedures to correct Type I and III endoleaks
Time frame: 10 years
Secondary endovascular procedure
Time frame: 10 years
Adverse Device Effects
Time frame: 10 years
Technical Observations
Time frame: 5 years
Aneurysm-related mortality
Time frame: 10 years
All-cause mortality
Time frame: 10 years
MAE
Time frame: 30 days
Health Related Quality of Life Scores
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Clínica La Sagrada Familia
Buenos Aires, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
St Andrew's Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Melbourne, Victoria, Australia
Epworth Healthcare - Epworth Eastern
Melbourne, Victoria, Australia
JMLS Medical Services PTY, trading as Perth Institute of Vascular Research
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
...and 70 more locations
Time frame: 10 years
AAA Diameter Increase
Time frame: 10 years