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A ProspeCtive mUlticenteR Investigation on RENzar Stent Safety and Efficacy in the Treatment of Patients With Femoro-popliteal Disease in Tuscany (CURRENT Registry) — CURRENT  

Peripheral Arterial Disease Clinical Trial

Official title:
A ProspeCtive mUlticenteR Investigation on RENzar Stent Safety and Efficacy in the Treatment of Patients With Femoro-popliteal Disease in Tuscany (CURRENT Registry)

Clinical Trial Summary

CURRENT Registry is a physician-initiated prospective, multicenter, post-market, single-arm study with a plan to include approximately 100 patients eligible to be treated with RenzanTM Peripheral Stent System.

Clinical Trial Description

In the last years, most of the technical evolution of materials dedicated to the treatment of femoropopliteal disease has been focused on drug-eluting technologies. However, in very complex lesions drug-coated balloons seems to be less efficient, leading to a high rate of bailout stenting with bare metal stents. Drug-eluting stents have raised expectation, providing structural scaffolding of the artery and active pharmacological treatment of the target lesion. Available evidence from the literature does not always seem to support this hypothesis. Still, a lot of rumours have been generated on the potential local and systemic toxicity of paclitaxel. As a consequence, in complex lesion rather than Drug Coated Balloon and Drug Eluting Stent it seems that there is need of a modern generation of nitinol stents with high Radial Resistive Force, low chronic outward forces and high fracture resistance. The device under investigation is the Renzan™ Peripheral Stent System from Terumo MicroVention Inc. (35 Enterprise, Aliso Viejo, California 92656, USA) . The System consists of a self-expanding nitinol stent pre-mounted on the distal portion of a rapid exchange (RX) delivery catheter. The stent is made of a nickel-titanium alloy with radiopaque markers on each end of the stent. The nitinol stent is constructed from 2 layers of tubular braided nitinol wire mesh. The outer layer consists of nitinol wire braided into a closed cell structure with flared ends. The inner layer consists of nitinol wire braided into a closed cell structure with micro sized pores. The delivery catheter has a rapid exchange port designed to allow coaxial passage of a 0.46mm (0.018") or smaller guide wire in diameter. The stent is capable of being recaptured when a minimum of 20mm of stent length remains inside the catheter. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05701293
Study type Observational
Source Azienda Ospedaliera Universitaria Senese
Contact Gianmarco de Donato, MD
Phone 00390577585123
Email dedonato@unisi.it
Status Recruiting
Phase
Start date December 1, 2022
Completion date December 1, 2026
View Details
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