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NCT02777593 · ClinicalTrials.gov registry record · NA
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
A NA study of Aortic Aneurysm, Thoracic and Aorta; Lesion, sponsored by W.L.Gore & Associates.
- Active
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT02777593: Active NA study of Aortic Aneurysm, Thoracic and Aorta; Lesion, sponsored by W.L.Gore & Associates.
NCT02777593 is a NA study of Aortic Aneurysm, Thoracic and Aorta; Lesion that is active but no longer recruiting, run by W.L.Gore & Associates. The registered enrollment target is 250 participants, above the 183-participant average among 4 other Aortic Aneurysm, Thoracic trials with a reported enrollment target (37% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02777593, a NA study of Aortic Aneurysm, Thoracic and Aorta; Lesion, is active but no longer recruiting, sponsored by W.L.Gore & Associates.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation of the device.
Primary Outcome
Primary Endpoint was composite of the following events: device technical success and absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device/procedure/withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal f
Conditions Studied
Interventions
- DEVICE GORE® TAG® Thoracic Branch Endoprosthesis
Study Locations (20)
California
- Keck Medical Center of USC - Los Angeles
- Cedar-Sinai Medical Center - Los Angeles
- Leland Stanford Junior University - Stanford
Florida
- University of Florida - Gainesville - Gainesville
- Univeristy of South Florida - Tampa
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- MedStar Health Research Institute - Washington D.C.
Georgia
- Emory University - Atlanta
Illinois
- Northwestern University - Chicago
Indiana
- St. Vincent Medical Group, Inc. - Indianapolis
Kentucky
- University of Louisville Jewish Hospital - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2016-09-06 |
| Est. Completion | 2027-12 |
| Phase | NA |
What the registry record for NCT02777593 still lists
NCT02777593 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 183-participant average among 4 other Aortic Aneurysm, Thoracic trials with a reported enrollment target (37% higher).
The record links to 2 conditions, with Aortic Aneurysm, Thoracic appearing as the primary indexed condition, and to 1 intervention - of which GORE® TAG® Thoracic Branch Endoprosthesis is the first listed.
NCT02777593 names 20 study sites across 17 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT02777593 about?
NCT02777593 is a clinical study titled "Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2". The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation of the device.
What is the current status of trial NCT02777593?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2016-09-06. Estimated completion is 2027-12.
What conditions does trial NCT02777593 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Thoracic, Aorta; Lesion.
What interventions are being tested in trial NCT02777593?
The interventions under investigation include: GORE® TAG® Thoracic Branch Endoprosthesis (DEVICE).
Who is sponsoring clinical trial NCT02777593?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02777593 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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