Endurant Stent Graft System Post Approval Study
This trial is active, not recruiting.
|Condition||aortic aneurysm, abdominal|
|Treatment||endurant stent graft system|
|Collaborator||Duke Clinical Research Institute|
|Start date||August 2011|
|End date||August 2017|
|Trial size||178 participants|
|Trial identifier||NCT01379222, 10012289|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Freedom from Aneurysm-related Mortality Rate (ARM) at 5 years (1826 days)
time frame: 5 years
Male or female participants at least 18 years old.
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.
|Official title||Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)|
|Principal investigator||Marc Schermerhorn, MD|
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