Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China (WingspanSSIR)
Recruitment status was: Recruiting
|Intracranial Atherosclerosis||Procedure: Stenting of atherosclerotic intracranial stenosis|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China|
- Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year [ Time Frame: One year ]
- 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. [ Time Frame: One year ]
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||October 2010|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Procedure: Stenting 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%.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685308
|Contact: Wei-Jian Jiang, MDemail@example.com|
|Beijiang Tiantan Hospital, The Capital Medical University||Recruiting|
|Beijing, China, 100050|
|Principal Investigator:||Wei-Jian Jiang, MD||Beijing Tiantan Hospital, The Capital Medical University, Beijing, China|