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

  • STATUS
    Recruiting
  • participants needed
    42
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Updated on 19 February 2024

Summary

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.

Details
Condition ['Aortic Aneurysm, Thoracic', 'Aorta; Lesion']
Age 99years or below
Clinical Study Identifier02777593
Last Modified on19 February 2024

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