Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China

Ischemic Stroke Clinical Trial

Official title: Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China-a Prospective Multicenter Registry Study

Status Completed

Clinical Trial Summary

The SAMMPRIS suggested that aggressive treatment was superior to intravascular stenting in patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high complication rate in patients in stenting group. However the intravascular therapy is going on because of low complication rate in considerable Chinese studies coming from several high volume stroke centers. Given to 12.2% patients failing to aggressive medical therap in the SAMMPRIS study, it is imperative to performing an multiple prospective registry study of stenting for patients with ICAS in China.

Clinical Trial Description

This study is a multicentre prospective single-arm registry study and the protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. This study is initiated by the investigators, with 20 participating stroke centres (see online supplementary appendix II), and plans to recruit 300 consecutive patients who meet the inclusion and exclusion criteria. After the enrolment, all participants would be evaluated at baseline, day 4, day 30, months 6, months 9 and year 1 (see online supplementary appendix I). The Wingspan stent system is provided by the Boston Scientific company and the Apollo stent is provided by the MicroPort Company, but they will not participate in data collection, analysis, editing or make decisions about the publication. This study is sponsored and conducted by the Cerebrovascular Disease Center of Tiantan Hospital in addition to its responsibility for data analysis. An independent Data and Safety Monitoring Board (DSMB) oversees the conduction, safety and efficacy of the study. ;

Related Conditions & MeSH terms

• Constriction, Pathologic
• Ischemic Stroke

• NCT number: NCT01968122
• Study type: Observational [Patient Registry]
• Source: Beijing Tiantan Hospital
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Completion date: December 2015