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

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Rev-01

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Hyogo
    • Kobe-city, Hyogo, Japan, 650-0046
      • Kobe City Medical Center General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment; Intervention Device: Rev-01	Device: Rev-01; Treatment arm patients have used Rev-01 at least once

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson K.K. Medical Company
• Investigators: Principal Investigator: Nobuyuki Sakai, M.D., D.M.Sc, Kobe City Medical Center General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (ESTIMATE): July 10, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 7, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Stroke; Thrombectomy; Revascularization; Ischemia; Cerebrovascular disease; Ischemic Stroke; Recanalization; Interventional Neuroradiology; Neurovascular Intervention; Brain clot; Clot Retriever; neurovascular clinical trial
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: Rev-01