At a glance
ClinicalIndex Comparison RecordN/ACompleted· 280 enrolled
Drug / intervention
Covera Vascular Covered Stent following PTA +1 moredevice
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.
A Prospective, Multi-Center, Randomized, Concurrently-Controlled Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits (AVeNEW)
In Brief
A clinical study evaluating Covera Vascular Covered Stent following PTA and Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon for Stenosis and Restenosis. Completed, enrolled 280 participants across 24 sites in 8 countries.
Detailed Summary
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStenosis, Restenosis
CountriesAustralia, Austria, Belgium, Germany, Netherlands, New Zealand, Switzerland, United States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartJun 2016
Primary CompletionAug 2018
Study CompletionFeb 2021
TodayJul 2026
First PostedJan 8, 2016
Enrollment StartJun 1, 2016
Primary CompletionAug 1, 2018
Study CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.5 years ago
Interventions
Covera Vascular Covered Stent following PTAdevice
Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloonprocedure
Treatment of stenoses with PTA only