Endurant Stent Graft System Post Approval Study (ENGAGE PAS)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/6/2019 |
| Start Date: | August 2011 |
| End Date: | December 2017 |
Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)
The purpose of the study is to demonstrate the long term safety and effectiveness of the
Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic
aneurysms in a post-approval environment, through the endpoints established in this protocol.
The clinical objective of the study is to evaluate the long term safety and effectiveness of
the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related
Mortality (ARM).
Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic
aneurysms in a post-approval environment, through the endpoints established in this protocol.
The clinical objective of the study is to evaluate the long term safety and effectiveness of
the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related
Mortality (ARM).
Inclusion Criteria:
- Age ≥18 years
- Indication for elective surgical repair of abdominal aortic aneurysm (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. 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 Clinical Investigational Plan (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
- Female of childbearing potential in whom pregnancy cannot be excluded or who is
lactating.
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