NCT05183399

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2017

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

December 20, 2021

Last Update Submit

January 6, 2023

Conditions

Iatrogenic Vessel Injury

Outcome Measures

Primary Outcomes (1)

  • Technical Success

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

    Day 1 to 1 Month

Secondary Outcomes (1)

  • Safety

    Day 1 to 12 months

Interventions

GORE® VIABAHN® EndoprosthesisDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 10, 2022

Study Start

December 1, 2016

Primary Completion

May 19, 2017

Study Completion

February 14, 2021

Last Updated

January 10, 2023

Record last verified: 2023-01