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

Johnson & Johnson K.K. Medical Company1 site in 1 country49 target enrollmentMay 2013

ConditionsAcute Ischemic Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Ischemic Stroke
Sponsor: Johnson & Johnson K.K. Medical Company
Enrollment: 49
Locations: 1
Primary Endpoint: Proportion of Patients Who Have Recanalization
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

November 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Johnson & Johnson K.K. Medical Company

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Proportion of Patients Who Have Recanalization

Time Frame: immediately post procedure

Proportion of subjects who had recanalization, TICI 2a or better

Secondary Outcomes

Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure(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)
Proportion of Subject Who Have Clot Migration/Embolization(immediately post procedure)