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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: Rev-01


Participation Criteria
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Eligibility Criteria
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Key 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Intervention Device: Rev-01 | Device: Rev-01<br>* Treatment arm patients have used Rev-01 at least once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Who Have Recanalization | Proportion of subjects who had recanalization, TICI 2a or better | immediately post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subject Who Have Clot Migration/Embolization |  | immediately post procedure | 
| Neurological Outcome: Proportion of mRS 0-2 at 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. | 90 days post procedure | 
| Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH) |  | 24-hour post procedure | 
| All Cause Mortality |  | 90 days post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemia, Stroke, Ischemic Stroke, Thrombectomy, Brain clot, Cerebrovascular disease, Recanalization, Revascularization, Clot Retriever, Neurovascular Intervention, Interventional Neuroradiology, neurovascular clinical trial