Treatment of Patients With Traumatic or Iatrogenic Vessel... | NCT05183399

Studies
Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries

NCT05183399

Sponsor

W.L.Gore & Associates

Status

Completed

Last Update Posted

Jan 10, 2023Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Iatrogenic Vessel Injury

Interventions

GORE® VIABAHN® Endoprosthesis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

May 19, 2017Actual

Completion Date

Feb 14, 2021Actual

First Submitted Date

Dec 20, 2021

First Submission Date that Met QC Criteria

Dec 20, 2021

First Posted Date

Jan 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2023

Last Update Posted Date

Jan 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
GORE® VIABAHN® Endoprosthesis	Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample