Multicenter study evaluating safety and the performance of the intracranial stent system (WS-01) for the treatment of intracranial atherosclerotic disease - WS-01 Investigator-initiated clinical trial

obuyuki Sakai, Kobe City Hospital Organization Kobe City Medical Center General Hospital0 个研究点目标入组 20 人开始时间: 2009年8月18日最近更新: 2023年10月17日

试验速览

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•1)Patients' age is 20 to 80 years, inclusive
•2)Ischemic stroke or TIA attributed to the target lesion and which is refractory to medical therapy
•3)A modified Rankin Score of <=3
•4)Target vessel diameter between 2 mm and 4.5 mm, inclusive
•5)Stenosis of the target lesion equal to, or greater than 50% and less than 100% based on Digital Subtraction Angiography assessment, and places in an intracranial artery (internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery)
•6)Target lesion that is <=14mm in length
•7)Ability to deliver the stent to the lesion
•8)Signed informed consent

•1)Any new neurological symptoms within 24 hours prior to enrollment
•2)Within 7 days post-stroke to study enrollment
•3)Angiographic evidence of intimal injury or dissection at the target lesion preventing predilation.
•4)Lesions that are highly calcified or otherwise do not allow access or appropriate expansion of the stent.
•5)Tandem stenosis that is not covered with one stent.
•6)Thrombolysis within 24 hours of enrollment
•7)Major surgical intervention within the past 30 days
•8)Patients for whom the required medication for the study (anti-coagulants, anti-platelets, etc.) are contraindicated.
•9)The diagnosis of cardioembolic stroke.
•10)Intracranial stenosis unrelated to atherosclerosis, such as following vasospasm, basilar meningitis, moyamoya-disease, vasculitis, or dissection,
•11)Female patients who are pregnant or intend to become pregnant during the study
•12)Intracranial tumor, arterio-venous malformation, or aneurysm >5mm in size in the target artery
•13)Life expectancy less than one year
•14)Renal failure with elevated serum creatinin level equal or over 2.0mg/dL
•15)History of allergic reaction to contrast medium
•16)History of allergic reaction to nickel-titanium alloy
•17)Patients who are participating other clinical trials
•18)Patients under the condition that the enrollment in the study is considered unsuitable

发起方

obuyuki Sakai, Kobe City Hospital Organization Kobe City Medical Center General Hospital