JPRN-jRCT1092220031
Completed
Phase 3
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 sites20 target enrollmentAugust 18, 2009
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- obuyuki Sakai, Kobe City Hospital Organization Kobe City Medical Center General Hospital
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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,
Outcomes
Primary Outcomes
Not specified
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