Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries

W.L.Gore & Associates30 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Iatrogenic Vessel Injury

Interventions

GORE® VIABAHN® EndoprosthesisDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Technical Success

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

Time frame: Day 1 to 1 Month

Secondary Outcomes

Safety

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

Time frame: Day 1 to 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.