Acute Ischemic StrokeNCT01895634
Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
A study testing Rev-01 in people with Acute Ischemic Stroke, run by Johnson & Johnson K.K. Medical Company at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Rev-01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteJapan
- Study dates
- May 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Rev-01
- Keywords
- Ischemia, Stroke, Ischemic Stroke, Thrombectomy, Brain clot, Cerebrovascular disease, Recanalization, Revascularization, Clot Retriever, Neurovascular Intervention, Interventional Neuroradiology, neurovascular clinical trial
- Medical subject headings
- Ischemic Stroke, Ischemia, Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rev-01Device
Treatment arm patients have used Rev-01 at least once
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Intervention Device: Rev-01 Receives: Device: Rev-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Have Recanalization
Proportion of subjects who had recanalization, TICI 2a or better
Measured: immediately post procedure
Secondary outcomes (4)
Proportion of Subject Who Have Clot Migration/Embolization
Measured: immediately post procedure
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.
Measured: 90 days post procedure
Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)
Measured: 24-hour post procedure
All Cause Mortality
Measured: 90 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson K.K. Medical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuyuki Sakai, M.D., D.M.Sc, Principal investigator, Kobe City Medical Center General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895634
- Sponsor's protocol ID
- Rev-01
- Status last verified
- Feb 2016
- First submitted
- 1 Jul 2013
- Last updated
- 7 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
- ClinicalTrials.gov ID
- NCT01895634
- Acronym / sponsor ID
- Rev-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- Ischemia, Stroke, Ischemic Stroke, Thrombectomy, Brain clot, Cerebrovascular disease, Recanalization, Revascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Johnson & Johnson K.K. Medical CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Posted 5 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Rev-01Intervention Device: Rev-01 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rev-01Treatment arm patients have used Rev-01 at least once | Device | Treatment |
Primary outcome
Proportion of Patients Who Have Recanalization
Time frame: immediately post procedure
Proportion of subjects who had recanalization, TICI 2a or better
4 secondary outcomes
Proportion of Subject Who Have Clot Migration/Embolization
Time frame: immediately post procedure
Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure
Time frame: 90 days post procedure
Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)
Time frame: 24-hour post procedure
All Cause Mortality
Time frame: 90 days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nobuyuki Sakai, M.D., D.M.Sc principal investigator
Kobe City Medical Center General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rev-01 in people with Acute Ischemic Stroke, run by Johnson & Johnson K.K. Medical Company at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Who Have Recanalization (time frame: immediately post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.