August 3, 2020
Terumo Europe Initiates Postmarket PRIZER Study of the Renzan Stent System
August 3, 2020—Terumo Europe NV announced the initiation of the prospective, multicenter, postmarket, single-arm PRIZER study to confirm the safety and efficacy of the company’s Renzan peripheral stent system in treating patients with superficial femoral and/or popliteal artery disease.
According to Terumo, the Renzan device consists of a self-expanding nitinol stent premounted on the distal portion of a rapid exchange delivery catheter, constructed from two layers of tubular braided nitinol wire mesh.
The PRIZER study is planned to enroll 135 patients at approximately 10 centers in five European countries. Patients will be stratified in two groups: femoropopliteal (n = 90) and isolated popliteal (n = 45). In addition to safety and efficacy, the study will assess the primary patency of the artery evaluated at 12 months compared with clinical results from other clinical trials using similar metallic scaffolds.
The Principal Investigator of the PRIZER study is Koen Deloose, MD, Head of Department of Vascular Surgery at AZ Sint Blasius Dendermonde hospital in Dendermonde, Belgium.
“My enthusiasm about the dual-layer Roadsaver stent in the carotid field can be investigated in this way in the even more challenging infrainguinal area,” commented Dr. Deloose in Terumo’s announcement. “In current times where drug-eluting technology is only reserved for high-risk patients and where the need for scaffolding post–drug-coated balloon treatment is high, a lot of interventionalists are really looking for a ‘daily practice’ modern scaffold that is extremely flexible, well balanced in chronic outward force and radial resistive force, and easy to implant accurately.”
Dr. Deloose continued, “The new 018-inch–compatible nitinol-braided Renzan stent with dual-layer technology over the full length showed in some proof-of-concept cases to respond extremely well to all my expectations. The PRIZER study offers us the possibility to further investigate the safety and efficacy of the Renzan peripheral stent system for treatment of superficial femoral and/or popliteal artery disease in 135 patients.”