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OpenTrials
Completed

NCT Number: NCT05183399

Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries

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).

Completed

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Key information

Conditions

Iatrogenic Vessel Injury

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.

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.

Treatment and study plan

GORE® VIABAHN® Endoprosthesis

Device

Primary outcomes

  1. 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

  1. Safety

    Time frame: Day 1 to 12 months

    The safety Endpoint is the occurrence of serious adverse events and deficiencies.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2021
First posted
Jan 10, 2022
Registry last updated
Jan 10, 2023

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.