BD announced today that enrolment has begun and the first patients have been treated in the postmarket surveillance study, CONNECT-AV.
CONNECT-AV is a prospective, single-arm, open-label study that will follow patients treated with the WavelinQ endovascular arteriovenous fistula (endoAVF) system for 24 months.
The study’s dual primary effectiveness endpoints are the percentage of subjects dialysing using successful two-needle cannulation for at least 75% of the dialysis sessions over a continuous 28-day period at six months, and the subjects maintaining primary patency at six months.
The primary safety endpoint is freedom from device- and procedure-related serious adverse events through 30 days. The trial is expected to enrol 280 participants in the USA.
“For more than 50 years, medicine has looked for a next-generation haemodialysis access procedure for patients with end-stage kidney disease (ESKD) that can truly change the treatment paradigm,” said Brandon Repko, medical director of nuclear imaging and therapeutic services at Butler Memorial Hospital in Butler, USA, who treated the first patient in the CONNECT-AV trial in March 2021. “The CONNECT-AV trial is the next step in proving WavelinQ endoAVF system’s role in 21st century AVF creation. My colleagues and I are thrilled to be a part of that patient care evolution.”
CONNECT-AV is one of two postmarket studies of the WavelinQ endoAVF aystem. The second study, WAVE-Global is a prospective, single-arm, open-label study that will follow patients treated with the WavelinQ endoAVF system for 24 months.
The WAVE-Global primary endpoints are the number of interventions needed post creation to facilitate and/or maintain AVF use at six months, and the proportion of participants with freedom from Clinical Events Committee adjudicated device- or procedure-related serious adverse events at 30 days. The trial is expected to enrol 150 participants globally (outside of the USA).
“Physicians already have real-world experience using the WavelinQ endoAVF system to create AVFs that make life-preserving haemodialysis possible,” said Panagiotis M Kitrou, assistant professor in interventional radiology at Patras University Hospital in Patras, Greece, and a principal investigator in the WAVE-Global study. “Both of these studies will provide important long-term data on the safety and effectiveness of WavelinQ endoAVF aystem to help make informed decisions about patient care.”
The first patient in the WAVE-Global trial was treated by Kitrou in December 2020 at Patras University Hospital.
