Clinical trial NCT01895634: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Ischemia
Stroke
Ischemic Stroke
Thrombectomy
Brain clot
Cerebrovascular disease
Recanalization
Revascularization
Clot Retriever
Neurovascular Intervention
Interventional Neuroradiology
neurovascular clinical trial
Lead sponsor: Johnson & Johnson K.K. Medical Company
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of Patients Who Have Recanalization
timeFrame: immediately post procedure
Secondary outcomes:
measure: Proportion of Subject Who Have Clot Migration/Embolization
timeFrame: immediately post procedure
measure: Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure
timeFrame: 90 days post procedure
measure: Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)
timeFrame: 24-hour post procedure
measure: All Cause Mortality
timeFrame: 90 days post-procedure
Other outcomes:
Locations:
city: Kobe-city
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
Study officials:
affiliation: Kobe City Medical Center General Hospital
name: Nobuyuki Sakai, M.D., D.M.Sc
role: PRINCIPAL_INVESTIGATOR
References: