WS-01 Investigator-initiated clinical trial

JRCT ID: jRCT1092220031

Registered date:18/08/2009

Basic Information

• Recruitment status: COMPLETED
• Health condition(s) or Problem(s) studied: patients with ischemic stroke or TIA attributable to intracranial atherosclerotic disease with >= 50% stenosis, refractory to medical treatment.
• Date of first enrollment: 18/08/2009
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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
Route of administration / Site of application:OTHER,NOT APPLICABLE
Dose per administration:1
device
Dosing frequency / Frequency of use:ONCE
6 months
Planned duration of intervention:6 months
Intended dose regimen:not applicable
detailes of teratment arms:
Comparative intervention name:not applicable
Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE
Route of administration / Site of application:NOT APPLICABLE
Dose per administration:
Dosing frequency / Frequency of use:
Planned duration of intervention:
Intended dose regimen:

Outcome(s)

• Primary Outcome: Clinical outcome (composite ipsilateral stroke and death) at 6 months

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nobuyuki Sakai, Kobe City Hospital Organization Kobe City Medical Center General Hospital
• Source(s) of Monetary Support: Ministry of Health Labour and Welfare
• Secondary ID(s): JMA-IIA00031