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NCT00608829 · ClinicalTrials.gov registry record · Phase 2
GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta
A Phase 2 study of Aortic Aneurysm, Thoracic, sponsored by W.L.Gore & Associates.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT00608829: Completed Phase 2 study of Aortic Aneurysm, Thoracic, sponsored by W.L.Gore & Associates.
NCT00608829 is a Phase 2 study of Aortic Aneurysm, Thoracic that has completed, run by W.L.Gore & Associates. The registered enrollment target is 23 participants, below the 240-participant average among 4 other Aortic Aneurysm, Thoracic trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00608829, a Phase 2 study of Aortic Aneurysm, Thoracic, has completed, sponsored by W.L.Gore & Associates.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.
Primary Outcome
Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (\>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).
Conditions Studied
Interventions
- DEVICE GORE TAG® Thoracic Endoprosthesis
Study Locations (1)
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2007-02 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT00608829 record still lists
NCT00608829 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 240-participant average among 4 other Aortic Aneurysm, Thoracic trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Aortic Aneurysm, Thoracic appearing as the primary indexed condition, and to 1 intervention - of which GORE TAG® Thoracic Endoprosthesis is the first listed.
NCT00608829 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00608829 about?
NCT00608829 is a clinical study titled "GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta". The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.
What is the current status of trial NCT00608829?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2007-02. Estimated completion is 2014-09.
What conditions does trial NCT00608829 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Thoracic.
What interventions are being tested in trial NCT00608829?
The interventions under investigation include: GORE TAG® Thoracic Endoprosthesis (DEVICE).
Who is sponsoring clinical trial NCT00608829?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00608829 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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