Cerebrovascular drug-eluting stents verse bare metal stents in the treatment of vertebral artery stenosis

Objective: To evaluate the safety and efficacy of the new drug-eluting stent in the treatment of vertebral artery stenosis. Methods: This study was a single-center, randomized controlled trial of pre-marketing I-II stage. 40 patients with the severe stenosis of the vertebral artery (≥70% stenosis) were enrolled in this study. All the patients were divided into experimental group and control group according to the ratio of 1: 1. In the experimental group, a new cerebrovascular drug-eluting stent system (MauroraStent) was used. In the control group, a bare metal stent (Apollo) was used. The primary outcomes were surgical-related complications within 30 days and in-stent restenosis on the 6 months after surgery. Secondary outcomes were as follows : ipsilateral transient ischemic attack, stroke, death, As well as all adverse events and serious adverse events. Results: Enrollment began in September 2014, and was done in september 2015 with 40 patients enrolled into the study. 12-month data including ipsilateral complication, transient ischemic attack, stroke and all adverse events were collected. Data entry and analysis are ongoing. Conclusions: This study will provide a clinical basis for the clinical application of drug-eluting stent in cerebrovascular disease, and provide reference for the later phase Ⅲ multicenter randomized controlled study. Key words: Vertebral artery stenosis; Drug-eluting stent; Bare metal stent; Randomized controlled trial