Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China "WingspanSSIR"

Recruiting

Phase N/A Results N/A

Trial Description

This is a prospective, multi-center, non-randomized trial to study one-year outcomes of the Wingspan system for the treatment of Chinese patients with symptomatic atherosclerotic severe intracranial stenosis.

Detailed Description

The study will enroll 200 Chinese patients with atherosclerotic intracranial stenosis of 70% to 99% that causes a recent ischemic neurologic event.
The Winspan stenting following undersized Gateway balloon angioplasty will be performed at experienced centers (at least 10 cases' experiences of using the Wingspan system to treat the patients with intracranial stenosis for each center).
The primary endpoint of the study, independently evaluated by neurologists, is any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year.

Conditions

Interventions

  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Aspirin Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
  • Stenting of atherosclerotic intracranial stenosis Procedure
    Other Names: Wingspan stenting for intracranial stenosis
    Intervention Desc: Patients will receive aspirin 300mg and clopidogrel 75mg per day for 3 days or more before stenting,and for at least 1 month after stenting. Modifiable risk factors will be controlled according to major international guidelines. All stenting procedures will be performed in an elective setting, and under local or general anesthesia. The study will be terminated if stroke or death rate within 30 days of the stenting exceeds 15%.

Trial Design

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

Trial Population

Chinese population with symptomatic severe stenosis of intracranial atherosclerosis

Patient Involvement

Patients will receive aspirin 300mg and clopidogrel 75mg per day for 3 days or more before stenting,and for at least 1 month after stenting. Modifiable risk factors will be controlled according to major international guidelines. Angiograph at baseline.

All stenting procedures will be performed in an elective setting, and under local or general anesthesia. The study will be terminated if stroke or death rate within 30 days of the stenting exceeds 15%.

Outcomes

Type Measure Time Frame Safety Issue
Primary Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year.
Secondary Ischemic stroke in the non-stented artery territory, hemorrhagic stroke and death from other vascular causes beyond 30 days, and emergent cerebral revascularization (ECER)and other major hemorrhages at any time within 1 year, and restenosis.
Primary Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year One year No

Sponsors