The trial will assess the Wrapsody endovascular stent graft for the treatment of stenosis or occlusion within dialysis outflow circuits
Merit Medical Systems has recruited the first patients in its Wrapsody arteriovenous (AV) access efficacy pivotal study (the WAVE Study).
The trial has been launched to evaluate the Wrapsody endovascular stent graft to treat stenosis or occlusion within dialysis outflow circuits.
Dr Jeffrey Hoggard has recruited the first two subjects with venous outflow peripheral lesions in the trial at RAC Surgery Centre in North Carolina.
Hoggard said: “We are pleased to announce the first subjects enrolled into the Merit Medical WAVE study. Stent grafts have a proven track record in dialysis AV access, and we are excited to evaluate the Wrapsody Stent Graft in our patients for this clinical trial.”
The Wrapsody endovascular stent graft is an investigational device with an expandable nitinol stent frame fully enclosed by an external layer of expanded polytetrafluoroethylene (ePTFE) and an internal layer of spun PTFE with an interposed non-porous fluoropolymer bonding layer.
Merit Medical’s WAVE Study is designed to compare the Wrapsody endovascular stent graft to percutaneous transluminal angioplasty (PTA) to treat venous outflow circuit stenosis or occlusion in hemodialysis patients.
The company intends to recruit 357 patients in the study across multiple sites in the US, Europe, Canada and New Zealand.
Merit Medical will assess a population of 244 patients with AVFs and 113 with AVGs in the trial. It plans to randomise treatment in patients with AVFs to the Wrapsody stent graft or PTA and follow study subjects for two years post-procedure.
The WAVE Study follows the completion of Wrapsody feasibility study, which recruited 46 patients in Europe.
Earlier, the company secured CE mark approval for the Wrapsody system and complements its other vascular access products such as the HeRO graft and the Surfacer inside-out access catheter system.
Merit Medical chairman and CEO Dr Fred Lampropoulos said: “The study has been designed to evaluate the safety and efficacy the Wrapsody Endovascular Stent Graft for the treatment of venous outflow circuit stenosis or occlusion in hemodialysis patients and represents an important step towards our goal of establishing the Wrapsody as the standard of care for the more than two million patients suffering from kidney disease around the world.”