Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Intravascular stent therapy Device
    Other Names: Gateway balloon plus Wingspan stent system; Apollo stent system
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: aggressive medical treatment
    Description: administer Aspirin (100mg/d) + Clopidogrel (75mg/d) for more than 5d before the operation (but Clopidogrel of loading dose 200mg in case of emergency operation for TIA); administer Aspirin (100mg/d) + Clopidogrel (75mg/d) for 90d and subsequent monoclonal antibody after the operation; control the primary risk factors (e.g. hypertension and high LDL); control the secondary risk factors (e.g. diabetes, blood lipid of not high LDL, smoking, obesity and hypomotility); and intervene the life style. Primary risk factors: target systolic pressure of <140mmHg (or <130mmHg in the diabetes patients); and LDL <70mg/dl (1.81mmol/L) or drop by 50%.

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary the target vessel stroke event within 30 days after stenting Yes
Secondary recurrent ischemic stroke in the involved vascular area between 30 days and 1 year postoperatively Yes

Sponsors