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Completed

NCT Number: NCT05414318

CTAG Dissection/Trauma Post Marketing Surveillance Japan

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

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Key information

Conditions

Thoracic Aortic Aneurysm Acute Aortic Syndrome Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Dissection, Thoracic Aorta Thoracic Aorta Injury Thoracic Aortic Dissection Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conformable GORE® TAG® Thoracic Endoprosthesis

Device

Thoracic Endoprosthesis

Primary outcomes

  1. 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)

    Number of subjects who achieved the primary entry tear exclusion

  2. Aortic Rupture

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

    Number of subjects with Aortic Rupture

  3. Major Device-related Adverse Events

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

    Number of subjects with major device-related adverse events

  4. Secondary Intervention Treatment

    Time frame: Post-procedure through 5 years (Day 1-2006)

    Incidence rate of secondary intervention treatment

  5. Change in Minimum True Lumen Diameter Adjacent to Treated Segment

    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)

    Change in minimum true lumen diameter adjacent to treated segment at each follow-up visit:

    Decrease (>=5mm) vs No change vs Increase (>=5mm)

  6. Change in Minimum True Lumen Diameter Distal to Treated Segment

    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)

    Change in minimum true lumen diameter distal to treated segment at each follow-up visit:

    Decrease (>=5mm) vs No change vs Increase (>=5mm)

  7. Change in Maximum False Lumen Diameter Adjacent to Treated Segment

    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)

    Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit:

    Decrease (>=5mm) vs No change vs Increase (>=5mm)

  8. Change in Maximum False Lumen Diameter Distal to Treated Segment

    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)

    Change in maximum false lumen diameter distal to treated segment at each follow-up visit:

    Decrease (>=5mm) vs No change vs Increase (>=5mm)

  9. Change in Maximum Lesion Diameter

    Time frame: 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)

    Change in maximum lesion diameter at each follow-up visit:

    Decrease (>=5mm) vs No change vs Increase (>=5mm)

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG)

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2022
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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