Firehorus Rapamycin Target Eluting Vertebral Artery Stent System in Clinical Application

Drug Eluting Stent Clinical Trial

Official title: A Prospective, Multicenter, Single-Arm, Objective Performance Criteria-Clinical Study: Evaluation for Safety and Efficacy of Firehorus Rapamycin Target Eluting Vertebral Artery Stent System in Clinical Application

Status Completed

Clinical Trial Summary

This clinical trial uses a prospective, multicenter, single-arm, objective performance criteria-design, aiming to evaluate the safety and effectiveness of Firehorus Rapamycin Target Eluting Vertebral Artery Stent System .

Clinical Trial Description

This clinical trial uses a prospective, multicenter, single-arm, objective performance criteria-design, aiming to evaluate the safety and effectiveness of Firehorus Rapamycin Target Eluting Vertebral Artery Stent System (hereinafter referred to as Firehorus) in clinical application, in which 6 clinical trial centers are selected to employ Firehorus to treat subjects who are screened according to inclusion and exclusion criteria defined in this protocol. During this clinical trial, postoperative immediate success rate of stent implantation is recorded after surgery; DSA angiographic follow up is performed at 6 months (±30 days) after surgery; in-stent restenosis rate (stenosis degree ≥50%) is evaluated; and clinical follow up is performed at 30 days (±7d), 6 months (±30d), 12 months (±30d) after surgery; in order to evaluate the safety and effectiveness of Firehorus in clinical application. Each subject is expected to participate in the trial for 12 months (±30d) from entering the group to completion of follow up. ;

Related Conditions & MeSH terms

• Drug Eluting Stent
• Vertebral Artery Stenosis
• Vertebrobasilar Insufficiency

• NCT number: NCT03859674
• Study type: Interventional
• Source: MicroPort NeuroTech Co., Ltd.
• Status: Completed
• Phase: N/A
• Start date: July 17, 2014
• Completion date: November 25, 2016