Back to resultsReperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
Primary Purpose
Acute Ischemic Stroke
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Rev-01
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Ischemia, Stroke, Ischemic Stroke, Thrombectomy, Brain clot, Cerebrovascular disease, Recanalization, Revascularization, Clot Retriever, Neurovascular Intervention, Interventional Neuroradiology, neurovascular clinical trial
Eligibility Criteria
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
Sites / Locations
- Kobe City Medical Center General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Intervention Device: Rev-01
Outcomes
Primary Outcome Measures
Proportion of Patients Who Have Recanalization
Proportion of subjects who had recanalization, TICI 2a or better
Secondary Outcome Measures
Proportion of Subject Who Have Clot Migration/Embolization
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.
Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)
All Cause Mortality
Full Information
NCT ID
NCT01895634
First Posted
July 1, 2013
Last Updated
February 4, 2016
Sponsor
Johnson & Johnson K.K. Medical Company
1. Study Identification
Unique Protocol Identification Number
NCT01895634
Brief Title
Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
Official Title
Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson K.K. Medical Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Ischemia, Stroke, Ischemic Stroke, Thrombectomy, Brain clot, Cerebrovascular disease, Recanalization, Revascularization, Clot Retriever, Neurovascular Intervention, Interventional Neuroradiology, neurovascular clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Intervention Device: Rev-01
Intervention Type
Device
Intervention Name(s)
Rev-01
Intervention Description
Treatment arm patients have used Rev-01 at least once
Primary Outcome Measure Information:
Title
Proportion of Patients Who Have Recanalization
Description
Proportion of subjects who had recanalization, TICI 2a or better
Time Frame
immediately post procedure
Secondary Outcome Measure Information:
Title
Proportion of Subject Who Have Clot Migration/Embolization
Time Frame
immediately post procedure
Title
Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure
Description
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.
Time Frame
90 days post procedure
Title
Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)
Time Frame
24-hour post procedure
Title
All Cause Mortality
Time Frame
90 days post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobuyuki Sakai, M.D., D.M.Sc
Organizational Affiliation
Kobe City Medical Center General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-city
State/Province
Hyogo
ZIP/Postal Code
650-0046
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
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