CTAG Dissection/Trauma Post Marketing Surveillance Japan

• Sponsor: W.L.Gore & Associates (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05414318
• Collaborator: (none)
• Enrollment: 55
• Anticipated Duration (Months): 88.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Thoracic Aortic Aneurysm; Thoracic Aorta Injury; Thoracic Aortic Dissection	Device: Conformable GORE® TAG® Thoracic Endoprosthesis

Study Design

• Study Type: Observational
• Actual Enrollment: 55 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis
• Actual Study Start Date: Jan 5, 2016
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Outcome Measures

Primary Outcome Measures

1. Primary entry tear exclusion [Within 1-month follow up after the initial procedure (30 days)]

   To evaluate how many subjects achieved the primary entry tear exclusion at 1-month follow up

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• W.L.Gore & Associates

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT05414318
• Other Study ID Numbers: JPS 16-01
• First Posted: Jun 10, 2022
• Last Update Posted: Jun 13, 2022
• Last Verified: Jun 1, 2022

• 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
• Additional relevant MeSH terms: Aneurysm, Dissecting; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic

Study Results

No Results Posted as of Jun 13, 2022