Status:

COMPLETED

CTAG Dissection/Trauma Post Marketing Surveillance Japan

Lead Sponsor:

W.L.Gore & Associates

Conditions:

Thoracic Aortic Aneurysm

Thoracic Aorta Injury

Eligibility:

All Genders

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 5 2016

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    December 23 2022

    Estimated Enrollment :

    55 Patients enrolled

    Trial Details

    Trial ID

    NCT05414318

    Start Date

    January 5 2016

    End Date

    December 23 2022

    Last Update

    October 3 2024

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