CTAG Dissection/Trauma Post Marketing Surveillance Japan

Completed

• Conditions: Thoracic Aortic Aneurysm; Thoracic Aortic Dissection; Thoracic Aorta Injury

• Registration Number: NCT05414318
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-05
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-10
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23
• Results First Submitted: 2023-09-14
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Results First Posted: 2024-10-03
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Entry Tear Exclusion	At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)	Number of subjects who achieved the primary entry tear exclusion
Aortic Rupture	Procedure through 5 years (Day 0-2006)	Number of subjects with Aortic Rupture
Major Device-related Adverse Events	Procedure through 5 years (Day 0-2006)	Number of subjects with major device-related adverse events
Secondary Intervention Treatment	Post-procedure through 5 years (Day 1-2006)	Incidence rate of secondary intervention treatment
Change in Minimum True Lumen Diameter Adjacent to Treated Segment	At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)	Change in minimum true lumen diameter adjacent to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Change in Minimum True Lumen Diameter Distal to Treated Segment	At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)	Change in minimum true lumen diameter distal to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Change in Maximum False Lumen Diameter Adjacent to Treated Segment	At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)	Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Change in Maximum False Lumen Diameter Distal to Treated Segment	At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)	Change in maximum false lumen diameter distal to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Change in Maximum Lesion Diameter	At each follow-up visit from 6 months through 5 years: 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)	Change in maximum lesion diameter at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)