At a glance
ClinicalIndex Comparison RecordN/ACompleted· 124 enrolled
Drug / intervention
GORE® VIABAHN® Stent Graftdevice
Likely dose
GORE® VIABAHN® Stent Graft on Day 1AI-extracted
Key inclusion· 1
- ✓Stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study - Treatment of Patients With Stenosis or Occlusion at the Venous Anastomosis of Synthetic Arteriovenous (AV) Access Graft
In Brief
An observational study evaluating GORE® VIABAHN® Stent Graft for Vascular Stent-Graft Stenosis. Completed, enrolled 124 participants across 17 sites.
Detailed Summary
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsVascular Stent-Graft Stenosis
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartJul 2020
Primary CompletionOct 2023
TodayJul 2026
First PostedJun 12, 2020
Enrollment StartJul 2, 2020
Primary CompletionOct 6, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.1 years ago
Interventions
GORE® VIABAHN® Stent Graftdevice
On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.