Reperfuse Ischemic Vessels with Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
- Conditions
- Acute Ischemic Stroke
- Registration Number
- JPRN-UMIN000011090
- Lead Sponsor
- Johnson & Johnson K.K. Medical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
- Acute intracranial hemorrhage - Mass effect or intracranial tumor - Extended early ischemic changes evidenced by CT or MRI - Administration of 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who have recanalization immediately post procedure
- Secondary Outcome Measures
Name Time Method Following neurological outcomes at 90 days post-procedure - mRS score - NIHSS score - BI score Proportion of patients with ICH (symptomatic and asymptomatic) at 24 hours post-procedure All cause mortality at 90 days post-procedure