Status:
COMPLETED
Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
Lead Sponsor:
Johnson & Johnson K.K. Medical Company
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
20-85 years
Phase:
NA
Brief Summary
The main objective of this study is to document that the thrombectomy catheter (Rev-01) is effective and safe when used for revascularization in subjects with acute ischemic stroke within 8 hours of s...
Eligibility Criteria
Inclusion
- Key
- Subject presenting with clinical signs and symptoms consistent with a diagnosis of acute ischemic stroke
- Onset of symptom is within 8 hours prior to treatment with Rev-01
- Treatment with IV t-PA is ineligible or ineffective
- Occluded (presenting TICI score of 0 or 1) M1 or M2 of MCA, basilar or vertebral artery, or intracranial segment of ICA, confirmed by angiography that it is accessible to the Rev-01
- NIHSS score is 8-30
- Prior to new focal disabling neurologic deficit, mRS score was 0-2
- Age from 20 y.o. to 85 y.o.
- Written informed consent to participate by subject or legal representative
- Key
Exclusion
- Subject presenting; ICA dissection, Angiitis, Arterial tortuosity that would prevent the device from reaching the target vessel, Arterial stenosis \> 50% that would prevent the device from reaching the target vessel, Evidence of acute intracranial hemorrhage, Evidence of mass effect or intracranial tumor, Evidence of extended early ischemic changes
- Subject with more than two major artery occluded
- Known sensitivity or ineligible to radiographic agent, or metallic allergy
- Administration of dabigatran or heparin within 48 hours preceding the onset of stroke and have an elevated APTT or PTT above twice of the normal range for the laboratory at presentation
- Known bleeding diathesis of current use of oral anticoagulants (e.g., warfarin sodium) with International Normalized Ration (INR) \> 3
- Platelet count \< 30,000/mm3
- Glucose \< 50 mg/dL
- Severe sustained hypertension (SBP \> 185mmHG or DBP \> 110mmHG) refractory to pharmacological management
- Life expectancy of less than 90 days
- Pregnancy or females who are lactating
- Current participation in an investigational drug or device study
- Otherwise determined by investigator to be medically unsuitable for participation
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01895634
Start Date
May 1 2013
End Date
November 1 2014
Last Update
March 7 2016
Active Locations (1)
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1
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan, 650-0046