Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending … (NCT02777593) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
United States250 participantsStarted 2016-09-06
Plain-language summary
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation of the device.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.
✓. Age ≥18 years at time of informed consent signature
✓. Subject is capable of complying with protocol requirements, including follow-up
✓. Informed Consent Form (ICF) is signed by Subject or legal representative
✓. Must have appropriate proximal aortic landing zone.
✓. Must have appropriate target branch vessel landing zone
✓. For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.
Exclusion criteria
✕. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
✕. Previous endovascular repair of the ascending aorta
✕. Previous endovascular repair of the DTA with a non-Gore device
✕. Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access
✕. Infected aorta
✕. Life expectancy \<2 years
What they're measuring
1
Proportion of Participants With Primary Endpoint Success for Zone 2
. Myocardial infarction within 6 weeks prior to treatment
✕. Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.