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Recruiting NCT07166133

GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study

No phase Interventional Aortic Arch Dissection Aortic Arch Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GORE® TAG® Thoracic Branch Endoprosthesis.
Who it may be relevant to
Registry conditions: Aortic Arch Dissection, Aortic Arch Aneurysm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.

Detailed description

Minimum of 125 total subjects with a TBE Device implantation procedure initiated in up to 50 Sites in the United States. Subjects will have follow-up at 1 Month, 6 Month, 1 Year, and annually thereafter for a minimum of 5-years and up to a maximum of 10 years.

Interventions

  • Device GORE® TAG® Thoracic Branch Endoprosthesis
    Lesions in aortic arch in Zone 0 or Zone 1

Primary outcome measures

  • Number of subjects with index endovascular procedure initiated after (or following) the surgical revascularization procedure [Time frame: Index Endovascular Procedure Only]
  • Device Technical Success (index procedure only) [Time frame: Index Endovascular Procedure Only]
  • Lesion-related mortality [Time frame: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure]
  • Disabling Stroke [Time frame: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure]
  • Permanent Paraplegia (within 30-days) [Time frame: Within 30 days of index endovascular procedure]
  • Permanent Paraparesis (within 30-days) [Time frame: Within 30 days of index endovascular procedure]
  • New onset renal failure (within 30-days) requiring on-going dialysis [Time frame: Within 30 days of index endovascular procedure]
  • Lesion rupture (treated area) [Time frame: Minimum of 60 months and up to a maximum 120 months]
  • Loss of aortic or branch patency [Time frame: Minimum of 60 months and up to a maximum of 120 months]
  • Endoleaks [Time frame: Minimum of 60 months and up to a maximum of 120 months]
Secondary outcome measures (12)
  • Access-related complications (index endovascular procedure only) [Time frame: Index endovascular procedure only]
  • Life threatening bleed (index endovascular procedure only) [Time frame: Index endovascular procedure only]
  • Stroke [Time frame: Minimum of 60 months and up to a maximum of 120 months]
  • Transient Ischemic Attack (TIA) [Time frame: Minimum of 60 months and up to a maximum of 120 months]
  • Paraplegia (within 30-days) [Time frame: Within 30 days of index endovascular procedure]
  • Paraparesis (within 30-days) [Time frame: Within 30 days of index endovascular procedure]
  • Distal device-related thromboembolic adverse event requiring intervention or surgery (through 1-Month) [Time frame: Through 1 Month of index endovascular procedure]
  • Myocardial infarction (within 30-days) [Time frame: Within 30 days of surgical revascularization procedure or within 30 days of index endovascular procedure]
  • Laryngeal or Phrenic Nerve injury (within 30-days) [Time frame: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure]
  • Fistula formation [Time frame: Minimum of 60 months and up to a maximum of 120 months]
  • Upper extremity ischemia [Time frame: Minimum of 60 months and up to a maximum of 120 months]
  • Lesion enlargement (treated area) [Time frame: Minimum of 60 months and up to maximum of 120 months]

Eligibility criteria

Inclusion criteria

  • Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
  • Patient has been or is intended to be treated with the TBE Device in Zone 0 or Zone 1.
  • Patient is age ≥ 18 years at time of informed consent signature.

Exclusion criteria

  • Patient who is, at the time of consent, unlikely to be available for defined follow-up visits.
  • Patient with exclusion criteria required by local law.
  • Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study within 12 months of study enrollment. Subjects cannot be enrolled in another Gore study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 13 centers
  • Keck Medical Center of USC — Los Angeles
  • Hartford Hospital — Hartford
  • University of Florida Health Heart & Vascular — Gainesville
  • Lakeland Regional Medical Center — Lakeland
  • University of South Florida — Tampa
  • University of North Carolina at Chapel Hill — Chapel Hill
  • Duke University Medical Center — Durham
  • The Methodist Hospital-Houston — Houston
  • … and 5 more centers

Identifiers

NCT: NCT07166133 · TBE 25-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗