Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China (WingspanSSIR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00685308|
Recruitment Status : Unknown
Verified May 2008 by Ministry of Health, China.
Recruitment status was: Recruiting
First Posted : May 28, 2008
Last Update Posted : May 28, 2008
|Condition or disease||Intervention/treatment|
|Intracranial Atherosclerosis||Procedure: Stenting of atherosclerotic intracranial stenosis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China|
|Study Start Date :||December 2007|
|Estimated Primary Completion Date :||October 2009|
|Estimated Study Completion Date :||October 2010|
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%.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|