Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke; Constriction, Pathologic
Study type: Observational [Patient Registry]

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.
    

Detailed 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.
    

Intervention name(s): intravascular stent therapy
Intervention type(s): Device
Intervention description(s): Device selection depended on arterial access and lesion morphology. For patients with smooth arterial access and Mori A lesion or the mid-basilar artery and distal M1 segment lesions, the Apollo balloon-mounted stent was selected. For patients with tortuous arterial access and Mori B or C lesion, or lesion with a significant mismatch in the diameter between proximal and distal segment, angioplasty plus self-expanding stent (Gateway balloon plus Wingspan stent system) is preferred . For patients with tortuous arterial access with a Mori A lesion, or small target vessel diameter (<2.5 mm), direct dilation with Gateway balloon was selected. If severe dissection or elastic recoil occurred after angioplasty, a balloon-mounted stent (for patients with less tortuous access) or Wingspan (for patients with severe tortuous access or small target vessel) stent were allowed to be implanted.
Other intervention name(s): Gateway balloon plus Wingspan stent system; Apollo stent system
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic
        atherosclerosis.Patients with ≥70% stenosis of angiopathic area symptomatic ICAD caused by
        hypoperfusion combined with poor collateral flow.
      
Keywords: symptomatic Intracranial artery stenosis; conventional treatment; stenting; stroke prevention; medical treatment; endovascular treatment