Clinical trial NCT05414318: CTAG Dissection/Trauma Post Marketing Surveillance Japan
Official title: Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Aortic Aneurysm
Thoracic Aorta Injury
Thoracic Aortic Dissection
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2022-06-10
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis


Eligibility 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

Primary outcomes:
measure: Primary Entry Tear Exclusion
timeFrame: 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)
measure: Aortic Rupture
timeFrame: Procedure through 5 years (Day 0-2006)
measure: Major Device-related Adverse Events
timeFrame: Procedure through 5 years (Day 0-2006)
measure: Secondary Intervention Treatment
timeFrame: Post-procedure through 5 years (Day 1-2006)
measure: Change in Minimum True Lumen Diameter Adjacent to Treated Segment
timeFrame: 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)
measure: Change in Minimum True Lumen Diameter Distal to Treated Segment
timeFrame: 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)
measure: Change in Maximum False Lumen Diameter Adjacent to Treated Segment
timeFrame: 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)
measure: Change in Maximum False Lumen Diameter Distal to Treated Segment
timeFrame: 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)
measure: Change in Maximum Lesion Diameter
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: