NCT04261686

Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft

A Prospective, Multi-Center, Non-Randomized 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) Post Approval Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prospective, multi-center, non-randomized clinical study designed to assess the long-term safety and effectiveness of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the AV access circuit of hemodialysis subjects dialyzing with an arteriovenous (AV) fistula.

Conditions

• Arteriovenous Fistula

Interventions

Type	Name	Description
DEVICE	Covera Vascular Covered Stent	This is a single-arm study. All subjects will receive the Covera Vascular Covered Stent

Timeline

• Start date: 2020-07-03
• Primary completion: 2025-09-16
• Completion: 2025-09-16
• First posted: 2020-02-10
• Last updated: 2025-12-16

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study