Abstract
PURPOSE: 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. MATERIALS AND METHODS: 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). RESULTS: Safety was 94.9% with no device-related deaths nor in-patient hospitalization. Technical success was 100%. TLPP rates at 1, 3, and 6 months were 100, 89.7, and 82.2%. ACPP rates at 1, 3, and 6 months were 98, 76.3, and 60.0%. Target stenoses were 81% restenotic, and 75% located in the cephalic vein arch. There were 35% non-target stenoses treated with angioplasty during the index procedure. CONCLUSION: The 6-month results of the AVeNEW PAS confirm results from the AVeNEW IDE clinical trial and demonstrate safety and efficacy using the Covera(()™()) Covered Stent in a real-world US hemodialysis patient population. TRIAL REGISTRATION: NCT04261686. LEVEL OF EVIDENCE: 3 - prospective, multicenter.