At a glance
ClinicalIndex Comparison RecordN/ACompleted· 108 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.
Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
In Brief
A clinical study evaluating Gore VIABAHN Endoprosthesis for Peripheral Artery Disease and Vascular Disease. Completed, enrolled 108 participants across 23 sites in 4 countries.
Detailed Summary
The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease, Vascular Disease
CountriesGermany, Italy, Sweden, United States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedSep 2015
Primary CompletionJul 2019
Study CompletionJul 2021
TodayJul 2026
First PostedSep 4, 2015
Enrollment StartSep 1, 2015
Primary CompletionJul 1, 2019
Study CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.8 years ago
Interventions
Gore VIABAHN Endoprosthesisdevice