Evaluation of the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
Recruiting
99 years and younger
All
42 participants needed
1 Location
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']
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Age: - 99 Years
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Gender: All
Updated on
09 Sep 2024.
Study ID: 825502
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