CTAG Dissection/Trauma Post Marketing Surveillance Japan

N/ACompletedNCT05414318

W.L.Gore & Associates55 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Thoracic Aortic Aneurysm Thoracic Aorta Injury Thoracic Aortic Dissection

Interventions

Conformable GORE® TAG® Thoracic EndoprosthesisDEVICE

Thoracic Endoprosthesis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary Entry Tear Exclusion

Number of subjects who achieved the primary entry tear exclusion

Time frame: 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

Time frame: Procedure through 5 years (Day 0-2006)

Major Device-related Adverse Events

Number of subjects with major device-related adverse events

Time frame: Procedure through 5 years (Day 0-2006)

Secondary Intervention Treatment

Incidence rate of secondary intervention treatment

Time frame: 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)

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)

Data from ClinicalTrials.gov

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