patients with ischemic stroke or TIA attributable to intracranial atherosclerotic disease with >= 50% stenosis, refractory to medical treatment.
Conditions
Interventions
Intervention type:DEVICE
Name of intervention:Self-expandable cerebral artery stent system (WS-01),not applicable
Dose form / Japanese Medical Device Nomenclature:OTHER,NOT APPLICABLE
Medical device
R
Sponsors
Nobuyuki Sakai, Kobe City Hospital Organization Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical outcome (composite ipsilateral stroke and death) at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of stent success Incidence of restenosis of the target lesion at 6 months Incidence of composite ipsilateral stroke and death at 30 days Incidence of composite all stroke and death at 6 months | — |
Countries
Japan
Contacts
Public ContactKIM CHUN HEE
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Outcome results
None listed