CTAG Dissection/Trauma Post Marketing Surveillance Japan

W.L. Gore & Associates

Status: Completed

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

Treatments: Device: Conformable GORE® TAG® Thoracic Endoprosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT05414318

JPS 16-01

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design