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NCT00816062 · ClinicalTrials.gov registry record · NA
Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms
A NA study of Aortic Aneurysm, Abdominal, sponsored by Medtronic Cardiovascular.
- Completed
- Registry status
- NA
- Development phase
- 94
- Enrollment target
- 18
- Study locations
NCT00816062: Completed NA study of Aortic Aneurysm, Abdominal, sponsored by Medtronic Cardiovascular.
NCT00816062 is a NA study of Aortic Aneurysm, Abdominal that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 94 participants, below the 143-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (34% lower). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00816062, a NA study of Aortic Aneurysm, Abdominal, has completed, sponsored by Medtronic Cardiovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 94 participants
- Enrollment target
- 18
- Study locations
Study Summary
The purpose of this study is to examine, through the endpoints established in this protocol, the long-term safety and effectiveness of the Talent Abdominal Stent Graft System, in a post-approval environment.
Primary Outcome
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 also be aneurysm related. All deaths were adjudicated by a Clinical Events Commit
Conditions Studied
Interventions
- DEVICE Talent Abdominal Stent Graft
Study Locations (18)
California
- USC Univerisity Hospital - Los Angeles
- Palo Alto VAMC - Palo Alto
Missouri
- St. John's Medical Research Institute - Springfield
- Barnes Jewish - St Louis
North Carolina
- East Carolina University - Greenville
- Forsyth Medical Center - Winston-Salem
Pennsylvania
- Lehigh Valley Hospital - Allentown
- Pinnacle Health Network - Harrisburg
South Dakota
- Sanford USD Medical Center - Sioux Falls
- North Central Heart Institute - Sioux Falls
Tennessee
- St. Mary's Medical Center - Knoxville
- Vanderbilt Vascular Surgery - Nashville
Delaware
- Christiana Care Health Services - Newark
District of Columbia
- Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2008-12 |
| Est. Completion | 2015-07 |
| Phase | NA |
What the finished NCT00816062 record still lists
NCT00816062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 143-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Aortic Aneurysm, Abdominal appearing as the primary indexed condition, and to 1 intervention - of which Talent Abdominal Stent Graft is the first listed.
NCT00816062 lists 18 locations in 12 states (California, Missouri, North Carolina).
Frequently Asked Questions
What is clinical trial NCT00816062 about?
NCT00816062 is a clinical study titled "Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms". The purpose of this study is to examine, through the endpoints established in this protocol, the long-term safety and effectiveness of the Talent Abdominal Stent Graft System, in a post-approval environment.
What is the current status of trial NCT00816062?
This trial is currently completed. It is a NA study. The enrollment target is 94 participants. The study started on 2008-12. Estimated completion is 2015-07.
What conditions does trial NCT00816062 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Abdominal.
What interventions are being tested in trial NCT00816062?
The interventions under investigation include: Talent Abdominal Stent Graft (DEVICE).
Who is sponsoring clinical trial NCT00816062?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00816062 being conducted?
This trial has 18 study locations across California, Delaware, District of Columbia, Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00816062's enrollment target sits among peer trials
94 7th of 8 higher than 2 of 8 other Aortic Aneurysm, Abdominal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Aneurysm, Abdominal 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.
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