Enrollment has begun and the first patients have been treated in the postmarket surveillance study, CONNECT-AV, of the WavelinQ (BD) endovascular arteriovenous fistula (endoAVF) system.
CONNECT-AV is a prospective, single-arm, open-label study that will follow patients treated with WavelinQ (BD) for 24 months.
The study’s dual primary effectiveness endpoints are the percentage of subjects dialyzing 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 enroll 280 participants in the U.S.
CONNECT-AV is one of two postmarket studies of the WavelinQ endoAVF system. 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 enroll 150 participants globally—outside of the U.S.