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Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance

Study acronym: TGR 23-02TA
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 36 to 37v11
  2. Study sites revised (36)v10
  3. Study sites: 34 to 36v9
  4. Trial sites expanded: 10 → 34 locationsv8
  5. Study sites: 9 to 10v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 6 to 9v6
  2. Study sites: 4 to 6v5
  3. Site details revised at 1 of 4 sitesv4
  4. Study sites: 3 to 4v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Apr 1, 2025 to Jun 19, 2025
    • Eligibility criteria expanded, about 4 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w/AC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.
Trial Details
NCT Number NCT06658730
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Vascular Disease, Dissection, Dissection Aortic Aneurysm, Dissection of Aorta, Aneurysm Thoracic, Aneurysm Dissecting, Transection Aorta, Intramural Hematoma
Related terms Aortic Aneurysm, Thoracic, Aortic Dissection, Vascular Diseases
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov