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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. ;


Study Design


Related Conditions & MeSH terms


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

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