Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05183399

Enrollment

Registered

2022-01-10

Start date

2016-12-01

Completion date

2021-02-14

Last updated

2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iatrogenic Vessel Injury

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).

Interventions

DEVICEGORE® VIABAHN® Endoprosthesis

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026