Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 2) (SSB 11-02)
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ClinicalTrials.gov Identifier: NCT02777593 |
Recruitment Status :
Recruiting
First Posted : May 19, 2016
Last Update Posted : February 9, 2022
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Sponsor:
W.L.Gore & Associates
Information provided by (Responsible Party):
W.L.Gore & Associates
Tracking Information | |||||||
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First Submitted Date ICMJE | May 12, 2016 | ||||||
First Posted Date ICMJE | May 19, 2016 | ||||||
Last Update Posted Date | February 9, 2022 | ||||||
Study Start Date ICMJE | August 2016 | ||||||
Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Composite of technical success and adverse events for Zone 2 Subjects (Aneurysm Cohort) [ Time Frame: one year ] Composite of the following events through 12 months: device technical success and absence of the following Core Lab and adverse events: 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, or withdrawal of the delivery system.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 2) | ||||||
Official Title ICMJE | Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta | ||||||
Brief 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: GORE® TAG® Thoracic Branch Endoprosthesis
Endovascular repair with the TBE Device
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Study Arms ICMJE |
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Publications * | Squiers JJ, DiMaio JM, Schaffer JM, Baxter RD, Gable CE, Shinn KV, Harrington K, Moore DO, Shutze WP, Brinkman WT, Gable DR. Surgical debranching versus branched endografting in zone 2 thoracic endovascular aortic repair. J Vasc Surg. 2022 Jun;75(6):1829-1836.e3. doi: 10.1016/j.jvs.2021.12.068. Epub 2022 Jan 5. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
315 | ||||||
Original Estimated Enrollment ICMJE |
285 | ||||||
Estimated Study Completion Date ICMJE | December 2026 | ||||||
Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02777593 | ||||||
Other Study ID Numbers ICMJE | SSB 11-02 Pivotal (Zone 2) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | W.L.Gore & Associates | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | W.L.Gore & Associates | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | W.L.Gore & Associates | ||||||
Verification Date | February 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |