CTAG Dissection/Trauma Post Marketing Surveillance Japan

NCT05414318 | Completed Results FDA Device

• 1 other identifier: JPS 16-01
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Thoracic Aortic Aneurysm; Thoracic Aorta Injury; Thoracic Aortic Dissection

Outcome Measures

Primary Outcomes (9)

• Primary Entry Tear Exclusion

  Number of subjects who achieved the primary entry tear exclusion

  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

  Procedure through 5 years (Day 0-2006)

• Major Device-related Adverse Events

  Number of subjects with major device-related adverse events

  Procedure through 5 years (Day 0-2006)

• Secondary Intervention Treatment

  Incidence rate of secondary intervention treatment

  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)

  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)

• 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)

  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)

• Change in Maximum False Lumen Diameter Adjacent to Treated Segment

  Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)

  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)

• Change in Maximum False Lumen Diameter Distal to Treated Segment

  Change in maximum false lumen diameter distal to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)

  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)

• Change in Maximum Lesion Diameter

  Change in maximum lesion diameter at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)

  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)

Interventions

Conformable GORE® TAG® Thoracic Endoprosthesis DEVICE

Thoracic Endoprosthesis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• W.L.Gore & Associates: lead

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Dissection, Thoracic Aorta

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Dissection; Dissection, Blood Vessel; Acute Aortic Syndrome

Results Point of Contact

• Title: Charee Robe
• Organization: W.L. Gore & Associates

crobe@wlgore.com

928-864-4048

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: January 5, 2016
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: October 3, 2024
• Results First Posted: October 3, 2024

Record last verified: 2024-06