Status:
COMPLETED
CTAG Dissection/Trauma Post Marketing Surveillance Japan
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Thoracic Aortic Aneurysm
Thoracic Aorta Injury
Eligibility:
All Genders
Brief Summary
Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 5 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 23 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05414318
Start Date
January 5 2016
End Date
December 23 2022
Last Update
October 3 2024
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