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Sponsored by: |
Ministry of Health, China |
Information provided by: | Ministry of Health, China |
ClinicalTrials.gov Identifier: | NCT00685308 |
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.
Condition | Intervention |
Intracranial Atherosclerosis |
Procedure: Stenting of atherosclerotic intracranial stenosis |
Drug Information available for: | Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China |
Estimated Enrollment: | 200 |
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) |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Chinese population with symptomatic severe stenosis of intracranial atherosclerosis
Inclusion Criteria:
Exclusion Criteria:
Contact: Wei-Jian Jiang, MD | 86-10-6706-1935 | cjr.jiangweijian@vip.163.com |
China | |||||
Beijiang Tiantan Hospital, The Capital Medical University | Recruiting | ||||
Beijing, China, 100050 |
Ministry of Health, China |
Principal Investigator: | Wei-Jian Jiang, MD | Beijing Tiantan Hospital, The Capital Medical University, Beijing, China |
Related Info 
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Responsible Party: | Beijing Tiantan Hospital, The Capital Medical University (CMU) ( Wei-Jian Jiang /Chairman of Interventional Neuroradiology ) |
Study ID Numbers: | 1122837 |
First Received: | May 23, 2008 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00685308 |
Health Authority: | China: Ministry of Health |
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