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NCT05414318 Clinical Trial

CTAG Dissection/Trauma Post Marketing Surveillance Japan

Thoracic Aortic Aneurysm Clinical Trial

Official title:
Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date May 2023
Source W.L.Gore & Associates
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Conformable GORE® TAG® Thoracic Endoprosthesis
Thoracic Endoprosthesis

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
W.L.Gore & Associates

Outcome
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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