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

NCT01895634 | Completed Results

• 1 other identifier: Rev-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Keywords

Ischemia; Stroke; Ischemic Stroke; Thrombectomy; Brain clot; Cerebrovascular disease; Recanalization; Revascularization; Clot Retriever; Neurovascular Intervention; Interventional Neuroradiology; neurovascular clinical trial

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Who Have Recanalization

  Proportion of subjects who had recanalization, TICI 2a or better

  immediately post procedure

Secondary Outcomes (4)

• Proportion of Subject Who Have Clot Migration/Embolization

  immediately post procedure

• Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure

  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

Study Arms (1)

Treatment

EXPERIMENTAL

Intervention Device: Rev-01

Device: Rev-01

Interventions

Rev-01 DEVICE

Treatment arm patients have used Rev-01 at least once

Treatment

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson K.K. Medical Company: lead

Study Sites (1)

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0046, Japan

Location

MeSH Terms

Conditions

Ischemic Stroke; Ischemia; Stroke; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Depertment Chief, Clinical Operation
• Organization: Johnson & Johnson K.K. Medical Company

yikeda5@its.jnj.com

+81-3-4411-6789

Study Officials

• Nobuyuki Sakai, M.D., D.M.Sc

  Kobe City Medical Center General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 10, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 7, 2016
• Results First Posted: February 5, 2016

Record last verified: 2016-02

Locations

JP (1)