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Clinical Trials/NCT05183399
NCT05183399
Completed
Not Applicable

Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries in Thoracic, Abdominal, and Pelvic Arteries

W.L.Gore & Associates0 sites30 target enrollmentDecember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Iatrogenic Vessel Injury
Sponsor
W.L.Gore & Associates
Enrollment
30
Primary Endpoint
Technical Success
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to confirm device efficacy and safety of the GORE® VIABAHN® Endoprosthesis (hereafter "VB device") for the treatment of traumatic or iatrogenic vessel injury in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries).

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
February 14, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
W.L.Gore & Associates
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Technical Success

Time Frame: Day 1 to 1 Month

A technical success is defined as is a successful device implantation and a successful hemostasis.

Secondary Outcomes

  • Safety(Day 1 to 12 months)

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