Status:
COMPLETED
Endurant Stent Graft Natural Selection Global Postmarket Registry
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Aortic Aneurysm, Abdominal
Eligibility:
All Genders
18+ years
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 subje...
Eligibility Criteria
Inclusion
- 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
- High probability of non-adherence to physician's follow-up requirements
- Current participation in a concurrent trial which may confound study results
Key Trial Info
Start Date :
April 8 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 23 2021
Estimated Enrollment :
1266 Patients enrolled
Trial Details
Trial ID
NCT00870051
Start Date
April 8 2009
End Date
September 23 2021
Last Update
February 9 2022
Active Locations (80)
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1
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1199ABD
2
Clínica La Sagrada Familia
Buenos Aires, Argentina, C1426EOB
3
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
4
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029