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NCT02777528 · 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 0/1
A NA study of Aortic Aneurysm, Thoracic and Aorta; Lesion, sponsored by W.L.Gore & Associates.
- Active
- Registry status
- NA
- Development phase
- 79
- Enrollment target
- 20
- Study locations
NCT02777528: Active NA study of Aortic Aneurysm, Thoracic and Aorta; Lesion, sponsored by W.L.Gore & Associates.
NCT02777528 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 79 participants, below the 226-participant average among 4 other Aortic Aneurysm, Thoracic trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02777528, 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
- 79 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.
Primary Outcome
Primary Endpoint was composite of the following events from the time of enrollment through one month following the endovascular procedure (through day 59 unless otherwise specified): initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysi
Conditions Studied
Interventions
- DEVICE GORE® TAG® Thoracic Branch Endoprosthesis
- PROCEDURE Revascularization Procedure
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
- University of South Florida - Tampa
North Carolina
- Carolinas HealthCare Systems - Charlotte
- Duke University Medical Center - Durham
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Georgia
- Emory University - Atlanta
Illinois
- Northwesten University - Chicago
Indiana
- St. Vincent Medical Group, Inc. - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2016-08 |
| Est. Completion | 2028-03 |
| Phase | NA |
What the registry record for NCT02777528 still lists
NCT02777528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 226-participant average among 4 other Aortic Aneurysm, Thoracic trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with Aortic Aneurysm, Thoracic appearing as the primary indexed condition, and to 2 interventions - of which GORE® TAG® Thoracic Branch Endoprosthesis is the first listed.
NCT02777528 names 20 study sites across 16 states, led by California, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02777528 about?
NCT02777528 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 0/1". 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.
What is the current status of trial NCT02777528?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 79 participants. The study started on 2016-08. Estimated completion is 2028-03.
What conditions does trial NCT02777528 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Thoracic, Aorta; Lesion.
What interventions are being tested in trial NCT02777528?
The interventions under investigation include: GORE® TAG® Thoracic Branch Endoprosthesis (DEVICE), Revascularization Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT02777528?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02777528 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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