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

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: GORE® VIABAHN® Endoprosthesis

• Registration Number: NCT04706273
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-25
• Primary Completion: 2019-07-11
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-12
• Study Completion: 2022-12-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

• Symptomatic peripheral arterial disease in superficial femoral artery lesions

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GORE® VIABAHN® Endoprosthesis	GORE® VIABAHN® Endoprosthesis	Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions.

Primary Outcome Measures

Name	Time	Method
Primary Assisted Patency	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.
Freedom From Target Lesion Revascularization	1, 12 and 24 months	Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point.
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies	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.
Number of Participants With a Stent Fracture	Month 12, 24, 36, 48 and 60	The number and proportion of stent fracture as assessed by Core lab

Trial Locations

Locations (1)

Kansai Rousai; 🇯🇵 Amagasaki, Hyogo, Japan