Endurant Stent Graft Natural Selection Global Postmarket Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,266
- Locations
- 80
- Primary Endpoint
- Treatment Success
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Treatment Success
Time Frame: 10 years
Secondary Outcomes
- Stent Graft Endoleaks(10 years)
- Aneurysm-related mortality(10 years)
- AAA Diameter Increase(10 years)
- Technical Observations(5 years)
- All-cause mortality(10 years)
- MAE(30 days)
- Adverse Device Effects(10 years)
- Health Related Quality of Life Scores(12 months)
- Stent Graft Migration(10 years)
- Stent Graft Patency(10 years)
- Secondary procedures to correct Type I and III endoleaks(10 years)
- Secondary endovascular procedure(10 years)
- Stent Graft Stenosis(10 years)