Acute Ischemic Stroke
Conditions
Keywords
Ischemia, Stroke, Ischemic Stroke, Thrombectomy, Brain clot, Cerebrovascular disease, Recanalization, Revascularization, Clot Retriever, Neurovascular Intervention, Interventional Neuroradiology, neurovascular clinical trial
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.
Interventions
DEVICERev-01
Treatment arm patients have used Rev-01 at least once
Sponsors
Johnson & Johnson K.K. Medical Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Have Recanalization | immediately post procedure | Proportion of subjects who had recanalization, TICI 2a or better |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH) | 24-hour post procedure | — |
| All Cause Mortality | 90 days post-procedure | — |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Intervention Device: Rev-01
Rev-01: Treatment arm patients have used Rev-01 at least once | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 70.6 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment Japan | 49 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 49 |
| serious Total, serious adverse events | 16 / 49 |
Outcome results
Primary
Proportion of Patients Who Have Recanalization
Proportion of subjects who had recanalization, TICI 2a or better
Time frame: immediately post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Proportion of Patients Who Have Recanalization | 36 participants |
Secondary
All Cause Mortality
Time frame: 90 days post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | All Cause Mortality | 2 participants |
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.
Time frame: 90 days post procedure
Population: Missing value was not be imputed (1 missing subject was because of the missing data at 90 days by subject IC withdrawal)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure | 30 participants |
Secondary
Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)
Time frame: 24-hour post procedure
Population: Missing value was not be imputed (1 missing subject was because of the death within 24 hours)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH) | 15 participants |
Secondary
Proportion of Subject Who Have Clot Migration/Embolization
Time frame: immediately post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Proportion of Subject Who Have Clot Migration/Embolization | 0 participants |