Ad-interim 6- and 12-month results from a prospective multicenter investigation on Renzan Stent in the treatment of patients with femoro-popliteal disease in Tuscany (CURRENT Registry).

Abstract

Background: The CURRENT registry is a prospective, multicenter, real-world investigation designed to evaluate the safety and effectiveness of the Renzan^™ stent (Terumo MicroVention Inc., Aliso Viejo, CA, USA) in patients with femoro-popliteal peripheral artery disease (PAD), including complex lesions and chronic limb-threatening ischemia (CLTI). This study reports the interim outcomes at 6 and 12 months.

Methods: A total of 89 patients with symptomatic PAD (Rutherford category IV-V 64.1%) were enrolled across three centers in Tuscany, Italy. All patients underwent endovascular treatment with the Renzan^™ dual-layer interwoven nitinol stent. Baseline and follow-up assessments included clinical evaluation and duplex ultrasound imaging. The primary safety endpoint was the composite rate of all-cause death, target lesion revascularization (TLR), and major amputation at 30 days. The primary efficacy endpoint was primary patency at 6 months. Estimated patency and reintervention rates were reported at 12 months using Kaplan-Meier analysis.

Results: Technical and procedural success was achieved in 100% of cases. At 30 days, no deaths, TLRs, or major amputations occurred. At 6 months, the composite safety endpoint was met in 94.3% of patients. Primary patency was 100% at 1 and 3 months, 92.0% at 6 months, and declined to 78.7% (95% CI: 55.3-88.1%) at 12 months. Freedom from TLR was 97.2% at 6 months and 78.5% (95% CI: 63.7-88.7%) at 12 months. Exploratory multivariable analysis identified diabetes mellitus, previous peripheral endovascular intervention, and below-the-knee involvement as independent predictors of loss of patency, whereas dual antiplatelet therapy beyond 1 months was associated with a reduced risk of patency loss.

Conclusions: The Renzan^™ stent demonstrated excellent early safety and efficacy outcomes in a challenging PAD population, with sustained mid-term patency despite a high proportion of complex lesions. These preliminary results support the use of this new mimetic stent design in real-world clinical settings and warrant further confirmation with longer-term follow-up.