GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
1 other identifier
observational
321
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2019
CompletedFirst Submitted
Initial submission to the registry
January 8, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2022
CompletedResults Posted
Study results publicly available
September 20, 2024
CompletedSeptember 20, 2024
October 1, 2023
2.9 years
January 8, 2021
October 10, 2023
May 21, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
GORE® VIABAHN® Endoprosthesis
Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions.
Interventions
Participants receiving the GORE® VIABAHN® Endoprosthesis
Eligibility Criteria
Patients with symptomatic peripheral arterial disease in superficial femoral artery lesions in Japan
You may qualify if:
- Symptomatic peripheral arterial disease in superficial femoral artery lesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kansai Rousai
Amagasaki, Hyōgo, Japan
Related Publications (1)
Iida O, Ohki T, Soga Y, Suematsu N, Nakama T, Yamaoka T, Tobita K, Ichihashi S. Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study. Vasc Med. 2024 Aug;29(4):416-423. doi: 10.1177/1358863X241233528. Epub 2024 Mar 27.
PMID: 38544413DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eric Novak
- Organization
- W. L. Gore & Associates
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2021
First Posted
January 12, 2021
Study Start
August 25, 2016
Primary Completion
July 11, 2019
Study Completion
December 14, 2022
Last Updated
September 20, 2024
Results First Posted
September 20, 2024
Record last verified: 2023-10