Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT02777593
Brief 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.
Detailed Description:
For Zone 2, there are two arms (Aneurysm arm, Non-aneurysm arm) and four cohorts, described as follows: Zone 2 Aneurysm, Zone 2 Dissection, Zone 2 Traumatic Transection, and Zone 2 Other Isolated Lesion. Continued access Subjects were enrolled in the Zone 2 Aneurysm arm. The Zone 2 Aneurysm cohort was the only cohort analyzed with a hypothesis test, however data was collected similarly for all cohorts and for continued access Subjects. Zone 2 Subjects enrolled for analysis were from the United States only.
Study:
NCT02777593
Study Brief:
Protocol Section:
NCT02777593