N/A
N=49
Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
Acute Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01895634 ↗Enrolled (actual)
49
Serious AEs
32.7%
Results posted
Feb 2016
Primary outcome: Primary: Proportion of Patients Who Have Recanalization — 36 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rev-01 (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson K.K. Medical Company
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Have Recanalization |
36 | — |
| SECONDARY Proportion of Subject Who Have Clot Migration/Embolization |
— | — |
| SECONDARY Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure |
30 | — |
| SECONDARY Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH) |
15 | — |
| SECONDARY All Cause Mortality |
2 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01895634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.