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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895634
• Other study ID #: Rev-01
• Status: Completed
• Phase: N/A
• First received: July 1, 2013
• Last updated: February 4, 2016
• Start date: May 2013
• Est. completion date: November 2014

Study information

• Verified date: February 2016
• Source: Johnson & Johnson K.K. Medical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia

Intervention

Device:
• Rev-01
Treatment arm patients have used Rev-01 at least once

Locations

Country	Name	City	State
Japan	Kobe City Medical Center General Hospital	Kobe-city	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson K.K. Medical Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients Who Have Recanalization	Proportion of subjects who had recanalization, TICI 2a or better	immediately post procedure	No
Secondary	Proportion of Subject Who Have Clot Migration/Embolization		immediately post procedure	No
Secondary	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	No
Secondary	Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)		24-hour post procedure	Yes
Secondary	All Cause Mortality		90 days post-procedure	Yes