The AVeNEW Post-Approval Study (AVeNEW PAS) follows upon results from the AVeNEW IDE clinical trial and was designed to provide additional clinical evidence of safety and effectiveness using the Covera™ Vascular Covered Stent to treat arteriovenous fistula (AVF) stenoses in a real-world hemodialysis patient population. One hundred AVF patients were prospectively enrolled at 11 clinical trial sites in the USA and treated with the covered stent after angioplasty of a clinically significant target stenosis. The primary safety outcome was freedom from any adverse event that suggests the involvement of the AV access circuit evaluated at 30 days. The primary efficacy outcome was Target Lesion Primary Patency (TLPP) at six months, determined by an independent core laboratory. Secondary outcome measures included technical success defined as successful deployment to the intended location and access circuit primary patency (ACPP). Safety was 94.9
