Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)

Not Applicable

Completed

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 symptom onset who are ineligible for treatment with IV t-PA, or in whom treatment with IV t-PA has been ineffective.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Treatment	Rev-01	Intervention Device: Rev-01

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Who Have Recanalization	immediately post procedure	Proportion of subjects who had recanalization, TICI 2a or better

Secondary Outcome Measures

Name	Time	Method
Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure	90 days post procedure	The Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death", or similar, as accurate.
Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)	24-hour post procedure
All Cause Mortality	90 days post-procedure
Proportion of Subject Who Have Clot Migration/Embolization	immediately post procedure