GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)

May 21, 2024 updated by: W.L.Gore & Associates
This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

321

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Amagasaki, Hyogo, Japan
        • Kansai Rousai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic peripheral arterial disease in superficial femoral artery lesions in Japan

Description

Inclusion Criteria:

  • Symptomatic peripheral arterial disease in superficial femoral artery lesions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GORE® VIABAHN® Endoprosthesis
Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions.
Device: GORE® VIABAHN® Endoprosthesis
Participants receiving the GORE® VIABAHN® Endoprosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Assisted Patency
Time Frame: 12 and 24 months
Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point.
12 and 24 months
Freedom From Target Lesion Revascularization
Time Frame: 1, 12 and 24 months
Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point.
1, 12 and 24 months
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies
Time Frame: Procedure day, 1, 12, 24, 36, 48 and 60 months
The number and proportion of the subjects for whom the occurrence of serious adverse events were reported.
Procedure day, 1, 12, 24, 36, 48 and 60 months
Number of Participants With a Stent Fracture
Time Frame: Month 12, 24, 36, 48 and 60
The number and proportion of stent fracture as assessed by Core lab
Month 12, 24, 36, 48 and 60

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Serious Adverse Events
Time Frame: Day 1 to Month 60
Day 1 to Month 60
Rate of Stent Fractures
Time Frame: Day 1 to Month 60
Day 1 to Month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Investigators

  • Study Director: Kei Kaneko, W. L. Gore & Associates G.K

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2016

Primary Completion (Actual)

July 11, 2019

Study Completion (Actual)

December 14, 2022

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 8, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JPS 16-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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