At a glance
ClinicalIndex Comparison RecordN/ACompleted· 321 enrolled
Drug / intervention
GORE® VIABAHN® Endoprosthesisdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
In Brief
An observational study evaluating GORE® VIABAHN® Endoprosthesis for Peripheral Arterial Disease. Completed, enrolled 321 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
Enrollment StartAug 2016
Primary CompletionJul 2019
First PostedJan 2021
Study CompletionDec 2022
TodayJul 2026
First PostedJan 12, 2021
Enrollment StartAug 25, 2016
Primary CompletionJul 11, 2019
Study CompletionDec 14, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.5 years ago
Interventions
GORE® VIABAHN® Endoprosthesisdevice
Participants receiving the GORE® VIABAHN® Endoprosthesis