An observational study in Aortic Aneurysm, Abdominal, sponsored by Medtronic Cardiovascular. Completed at 80 sites in 30 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Medtronic Cardiovascular (part of Medtronic) · Observational
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.
481 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's enrollment of 1,266 is above the median of 167 across 225 observational studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Medtronic Cardiovascular is the lead sponsor of 70 studies on the registry; 7 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects diagnosed with an AAA who are considered candidates for endovascular
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Endurant Stent Graft implantation
Also known as: EVAR
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.
Time frame: 10 years
AAA Diameter Increase
Time frame: 10 years
Plan to share: No — Only multi center data will be available
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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