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NCT01379222 · ClinicalTrials.gov registry record · NA
Endurant Stent Graft System Post Approval Study (ENGAGE PAS)
A NA study, sponsored by Medtronic Cardiovascular.
- Completed
- Registry status
- NA
- Development phase
- 178
- Enrollment target
NCT01379222: Completed NA study, sponsored by Medtronic Cardiovascular.
NCT01379222 is a NA study that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 178 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01379222, a NA study, has completed, sponsored by Medtronic Cardiovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 178 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Aneurysm-Related Mortality (ARM) is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should be aneurysm related. \> All deaths will be adjudica
Interventions
- DEVICE Endurant Stent Graft System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2011-08 |
| Est. Completion | 2017-12 |
| Phase | NA |
What the finished NCT01379222 record still lists
NCT01379222 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Endurant Stent Graft System is the first listed.
NCT01379222 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01379222 about?
NCT01379222 is a clinical study titled "Endurant Stent Graft System Post Approval Study (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 ...
What is the current status of trial NCT01379222?
This trial is currently completed. It is a NA study. The enrollment target is 178 participants. The study started on 2011-08. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01379222?
The interventions under investigation include: Endurant Stent Graft System (DEVICE).
Who is sponsoring clinical trial NCT01379222?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01379222's enrollment target sits among peer trials
178 604th of 2000 higher than 1,397 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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