Intracranial Atherosclerosis
Conditions
Keywords
Atherosclerosis, Intracranial artery, Angioplasty, Stent
Brief summary
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.
Interventions
PROCEDUREStenting of atherosclerotic intracranial stenosis
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%.
Sponsors
Ministry of Health, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* An angiographically verified ≥ 70% stenosis of a major intracranial artery that causes TIA or minor stroke (NIH Stroke Scale score \<9) within 90 days; * the lesion length \<15 mm and normal arterial diameter adjacent to it between 2.0 mm and 4.5 mm; * patients having at least one atherosclerotic risk factor (arterial hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia and cigarette smoking).
Exclusion criteria
* Non-atherosclerotic stenosis; * intracranial hemorrhage in the territory of the stenotic artery within 6 weeks; potential source of cardiac embolism; * concurrent intracranial tumor, aneurysm and cerebral arteriovenous malformation; * tandem \>50% stenosis of extracranial carotid or vertebral artery; known contraindication to heparin, aspirin, clopidogrel, anesthesia and contrast media; hemoglobin \<10 g/dl, platelet count \<100,000; * international normalized ratio \>1.5 (irreversible) and uncorrectable bleeding diathesis; and life expectancy \<1 years because of other medical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year | One year |
Secondary
| Measure | Time frame |
|---|---|
| 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. | One year |
Countries
China
Contacts
Primary ContactWei-Jian Jiang, MD
Outcome results
None listed