NCT02790606

Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in AV Graft Patients (AVeVA)

Prospective, Multi-Center Clinical Study of the Bard® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis at the Graft-Vein Anastomosis of AV Graft Circuits (AVeVA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will compare the use of the COVERA™ Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to safety and effectiveness performance goals (PGs) for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of subjects dialyzing with an AV graft.

Conditions

• Stenosis
• Restenosis

Interventions

Type	Name	Description
DEVICE	Covera(TM) Vascular Covered Stent	Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-08-01
• Completion: 2019-03-16
• First posted: 2016-06-06
• Last updated: 2020-04-14
• Results posted: 2019-02-26

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study