Evaluation of the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta

Evaluation of the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta

Brief description of study

The purpose of this study is to evaluate the safety and effectiveness of the study device, which is an endoprosthesis (stent) that is used to treat various lesions of the aortic arch and descending thoracic aorta. Lesions might include aortic aneurysm (weakened area of the aorta), dissection (tear in the wall of the aorta), and traumatic aortic injury, among other possibilities. Subjects must have such an aortic lesion, which requires surgical repair, and must meet specific anatomical and disease conditions to be eligible for the study. If eligible, subjects will undergo surgical repair of the descending thoracic aorta or aortic arch, as appropriate, using the study device. Subjects are required to return for follow-up visits after the procedure at 30-days, 6 months, 12 months, and annually thereafter up to 5 years. The study may last a total of 8 years.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    ['Aortic Aneurysm, Thoracic', 'Aorta; Lesion']
  • Age: - 99 Years
  • Gender: All
Updated on 09 Mar 2024. Study ID: 825502

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