CTAG Dissection/Trauma Post Marketing Surveillance Japan

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

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	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)

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 (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• 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