Thoracic Aortic Aneurysm Clinical Trial
Official title:
Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis
NCT number | NCT05414318 |
Other study ID # | JPS 16-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 5, 2016 |
Est. completion date | December 23, 2022 |
Verified date | May 2023 |
Source | W.L.Gore & Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis
Status | Completed |
Enrollment | 55 |
Est. completion date | December 23, 2022 |
Est. primary completion date | December 23, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria for Acute, Complicated Stanford Type B Aortic Dissection: - Patient present with acute complicated type B aortic dissection - Patient who do not respond to medical therapy - Time from symptom onset to dissection diagnosis = 14 days - Adequate iliac / femoral access or conduit - Aortic inner diameter at proximal extent of proximal landing zone in the range of 16-42 mm - = 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected Inclusion Criteria for Traumatic Aortic Transection: - Patient has traumatic aortic transection that requires repair as determined by treating physician - Adequate iliac / femoral access - Aortic inner diameter in the range of 16-42 mm on the proximal and distal sides - = 20 mm non-aneurysmal aorta neck proximal and distal to the lesion |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
W.L.Gore & Associates |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary entry tear exclusion | To evaluate how many subjects achieved the primary entry tear exclusion at 1-month follow up | Within 1-month follow up after the initial procedure (30 days) |
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