A new post-market study investigating the effectiveness of the Renzan peripheral stent system (Terumo) in patients with peripheral arterial disease (PAD) has been initiated.
The PRIZER (Prospective, multicentre post-market, single-arm study, to confirm the performance of the Renzan peripheral stent system in treating subjects with superficial femoral and/or popliteal artery disease) study plans to enrol 135 patients, in approximately 10 European centres in five countries. Patients will be stratified into two groups: 90 patients with arterial disease in both the femoral and popliteal segments, and 45 patients with isolated popliteal artery disease.
The Renzan peripheral stent system consists of a self-expanding nitinol stent pre-mounted on the distal portion of a rapid exchange (RX) delivery catheter, constructed from two layers of tubular braided nitinol wire mesh.
As well as aiming to confirm the safety and efficacy of the Renzan peripheral stent system in treating patients with superficial femoral and/or popliteal artery disease, the PRIZER study aims to assess the primary patency of the artery evaluated at 12 months, compared to clinical results coming from other clinical trials using similar metallic scaffolds.
“My enthusiasm about the dual layer Roadsaver stent in the carotid field can be investigated in this way in the even more challenging infra-inguinal area”, comments Koen Deloose, head of Department of Vascular Surgery at AZ Sint Blasius Dendermonde hospital in Dendermonde, Belgium, and principal investigator of the PRIZER study. “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. The new 018″-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”, Deloose continues.
“We are very proud to contribute to our commitment to physicians and their patients and drive innovation in the field of peripheral artery disease”, says Jim Rushworth, chief commercial officer, Terumo Global. “With this clinical trial, we explore initiatives to increase our footprint in peripheral interventions.”
“This new technology ensures a great flexibility, conformability to the vessel, and fracture resistance”, comments Christophe Giot, chief medical officer, Terumo Europe. “The PRIZER study aims to provide scientific evidence for RENZAN stent in patients suffering from peripheral arterial disease.”
Peripheral arterial disease affects more than 200 million people worldwide
PAD is a progressive disorder caused by atherosclerotic changes in the blood vessel wall, which result in stenosis or occlusion of the arteries outside the heart and brain. The pathology affects more than 200 million people worldwide. In the last decade, the number of PAD-affected individuals increased by 13% in high- and by 29% in low-income countries. The PAD prevalence increases with age, affecting over 20% of octogenarians. Lower extremity PAD is its most common subset. PAD is associated with high morbidity and both cardiovascular and all-cause mortality rates. The pathology causes major personal, medical, and socio-economic burden, increasingly becoming a global healthcare concern.