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NCT00413231 · ClinicalTrials.gov registry record · NA
Valor II: The Valiant Thoracic Stent Graft System Clinical Study
A NA study of Thoracic Aortic Aneurysm, sponsored by Medtronic Cardiovascular.
- Completed
- Registry status
- NA
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT00413231: Completed NA study of Thoracic Aortic Aneurysm, sponsored by Medtronic Cardiovascular.
NCT00413231 is a NA study of Thoracic Aortic Aneurysm that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 160 participants, below the 889-participant average among 7 other Thoracic Aortic Aneurysm trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00413231, a NA study of Thoracic Aortic Aneurysm, has completed, sponsored by Medtronic Cardiovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.
Primary Outcome
Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.
Conditions Studied
Interventions
- DEVICE Valiant Thoracic Stent Graft System
Study Locations (20)
New York
- Albany Medical Center - Albany
- New York University Medical Center - New York
- Mount Sinai School of Medicine - New York
California
- University of Southern California - Healthcare Consultation Center - Los Angeles
- Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center - Torrance
Florida
- University of Florida - Gainesville
- University of South Florida - Tampa
Alabama
- University of Alabama at Birmingham - Birmingham
Connecticut
- Hartford Hospital - Hartford
Georgia
- Emory University Hospital - Atlanta
Illinois
- Loyola University Medical Center - Maywood
Maryland
- Union Memorial - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2006-12 |
| Est. Completion | 2014-10 |
| Phase | NA |
What the finished NCT00413231 record still lists
NCT00413231 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 889-participant average among 7 other Thoracic Aortic Aneurysm trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Thoracic Aortic Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which Valiant Thoracic Stent Graft System is the first listed.
NCT00413231 names 20 study sites across 16 states, led by New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00413231 about?
NCT00413231 is a clinical study titled "Valor II: The Valiant Thoracic Stent Graft System Clinical Study". This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.
What is the current status of trial NCT00413231?
This trial is currently completed. It is a NA study. The enrollment target is 160 participants. The study started on 2006-12. Estimated completion is 2014-10.
What conditions does trial NCT00413231 study?
This clinical trial studies the following conditions: Thoracic Aortic Aneurysm.
What interventions are being tested in trial NCT00413231?
The interventions under investigation include: Valiant Thoracic Stent Graft System (DEVICE).
Who is sponsoring clinical trial NCT00413231?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00413231 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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