CTAG Dissection/Trauma Post Marketing Surveillance Japan

Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG)

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

Study Overview

• Status: Completed
• Conditions: Thoracic Aortic Aneurysm; Thoracic Aortic Dissection; Thoracic Aorta Injury
• Intervention / Treatment: Device: Conformable GORE® TAG® Thoracic Endoprosthesis

• Study Type: Observational
• Enrollment (Actual): 55

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute, complicated Stanford Type B aortic dissection and patients with traumatic aortic transection treated using Gore CTAG.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Entry Tear Exclusion	Number of subjects who achieved the 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)
Aortic Rupture	Number of subjects with Aortic Rupture	Procedure through 5 years (Day 0-2006)
Major Device-related Adverse Events	Number of subjects with major device-related adverse events	Procedure through 5 years (Day 0-2006)
Secondary Intervention Treatment	Incidence rate of secondary intervention treatment	Post-procedure through 5 years (Day 1-2006)
Change in Minimum True Lumen Diameter Adjacent to Treated Segment	Change in minimum true lumen diameter adjacent to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm)	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	Change in minimum true lumen diameter distal to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm)	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	Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm)	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	Change in maximum false lumen diameter distal to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm)	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 Lesion Diameter	Change in maximum lesion diameter at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm)	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)

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2016
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Dissection; Dissection, Thoracic Aorta
• Other Study ID Numbers: JPS 16-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes