Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
NCT04261686 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-12-16
Summary
The objective of this study is to collect post-market, real-world safety and effectiveness data of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit.
Conditions
- Arteriovenous Fistula
Interventions
- DEVICE
-
Covera Vascular Covered Stent
This is a single-arm study. All subjects will receive the Covera Vascular Covered Stent
Sponsors & Collaborators
-
C. R. Bard
lead INDUSTRY
Principal Investigators
-
Bart Dolmatch, M.D. · The Palo Alto Medical Foundation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-03
- Primary Completion
- 2025-09-16
- Completion
- 2025-09-16
- FDA Device
- Yes
Countries
- United States
Study Locations
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