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

Johnson & Johnson (J&J)

Status

Completed

Conditions

Acute Ischemic Stroke

Treatments

Device: Rev-01

Study type

Interventional

Funder types

Industry

Identifiers

NCT01895634

Rev-01

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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