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

NCT ID: NCT01895634

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-11-30

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Intervention Device: Rev-01

Group Type: EXPERIMENTAL

Rev-01

Intervention Type: DEVICE

Treatment arm patients have used Rev-01 at least once

Interventions

Rev-01

Treatment arm patients have used Rev-01 at least once

Intervention Type: DEVICE

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
• Current participation in an investigational drug or device study
• Otherwise determined by investigator to be medically unsuitable for participation

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson K.K. Medical Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nobuyuki Sakai, M.D., D.M.Sc

Role: PRINCIPAL_INVESTIGATOR

Kobe City Medical Center General Hospital

Locations

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Countries

Japan

Other Identifiers

Rev-01

Identifier Type: -

Identifier Source: org_study_id