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

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: Peripheral Arterial Disease
• Intervention / Treatment: Device: GORE® VIABAHN® Endoprosthesis

• Study Type: Observational
• Enrollment (Actual): 321

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

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	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	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	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	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	Day 1 to Month 60
Rate of Stent Fractures	Day 1 to Month 60

Collaborators and Investigators

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

Study record dates

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: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• 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