The AV fistula arm of the WAVE trial enrolled 245 patients at 43 sites. Patients were randomized 1:1 to WRAPSODY or percutaneous transluminal angioplasty (PTA).

The single-arm cohort of the WAVE trial included 112 patients with an AVG who were treated with the WRAPSODY CIE device. The primary efficacy measure, 6-month TLPP, was compared to an efficacy ...

An AV fistula is used over other alternatives, such as catheters or artificial grafts, since it uses the patient's veins, lowering the risk of infection, clotting, and other complications.