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Treatment of Patients With Tr...

Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2021-02-14

Brief Summary

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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).

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Detailed Description

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Conditions

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Iatrogenic Vessel Injury

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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GORE® VIABAHN® Endoprosthesis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients with traumatic or iatrogenic vessel injuries in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries ) with a reference vessel diameter ranging from 4.0 to 12.0mm.

Eligible Sex

ALL

Accepts Healthy Volunteers