Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries

Completed

• Conditions: Iatrogenic Vessel Injury

• Registration Number: NCT05183399
• Lead Sponsor: W.L.Gore & Associates

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2017-05-19
• Study Completion: 2021-02-14
• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2022-01-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical Success	Day 1 to 1 Month	A technical success is defined as is a successful device implantation and a successful hemostasis.

Secondary Outcome Measures

Name	Time	Method
Safety	Day 1 to 12 months	The safety Endpoint is the occurrence of serious adverse events and deficiencies.