Ischemic Stroke
Conditions
Keywords
Ischemic Stroke, SOLITAIRE™ Device, SOLITAIRE™, MERCI® Device, MERCI®, Stroke, Ischemic, Mechanical Thrombectomy, Brain, Brain Clot, Brain Artery Revascularization, Recanalization, Brain Stroke, Clot Retriever, Device, Neurosurgery, Neurovascular Intervention, Interventional Neuroradiology, Brain study, neurovascular clinical trial
Brief summary
The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.
Interventions
DEVICESOLITAIRE™ Device
The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure
DEVICEMERCI® Device
The MERCI® Device is the control device that will be used in the interventional procedure.
Sponsors
Medtronic Neurovascular Clinical Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient or patient's legally authorized representative has signed and dated an Informed Consent Form * Age22-85 * Clinical signs consistent with acute ischemic stroke * National Institutes of Health Stroke Scale (NIHSS) ≥8and\<30 * Thrombolysis in Myocardial Infarction (TIMI) 0 or TIMI 1 flow in the M1 or M2 of middle cerebral artery, internal carotid artery, basilar or vertebral arteries confirmed by angiography that is accessible to the SOLITAIRETM or MERCI® Device * Patient is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the SOLITAIRETM or MERCI® Device. * Patient who is ineligible or failed intravenous tissue plasminogen activator (t-PA) therapy given at local institutions or within national practice. * Patient is willing to conduct follow-up visits
Exclusion criteria
* NIHSS \> 30 or coma * Neurological signs that are rapidly improving prior to or at time of treatment * Females who are pregnant or lactating * Known serious sensitivity to radiographic contrast agents * Current participation in another investigation drug or device study * Uncontrolled hypertension defined as systolic blood pressure \> 185 or diastolic blood pressure \> 110 that cannot be controlled except with continuous parenteral antihypertensive medication * Use of warfarin anticoagulation with International Normalized Ratio (INR) \> 3.0 * Platelet count \< 30,000 * Glucose \< 50 mg/dL * Arterial tortuosity that would prevent the device from reaching the target vessel * Life expectancy of less than 90 days * Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation * CT showing hypodensity or MR showing hyperintensity involving greater than 1/3 of the middle cerebral artery (MCA) territory (or in other territories, \>100 cc of tissue) on presentation * CT or MRI evidence of mass effect or intracranial tumor (except small meningioma) * Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage | Immediately post treatment | Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes. Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy. TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome) |
| Study Device-related Serious Adverse Events (SAEs) | 90 Day | Incidence of study device-related Serious Adverse Events (SAEs) |
| Procedure-related Serious Adverse Events (SAEs) | 90 Day | Incidence of study procedure-related Serious Adverse Events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 90 Days follow-up | Rate of Mortality |
| Time to Initial Recanalization | post treatment | Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow |
| Non-fatal Stroke-related Morbidity | 90 Day | Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events |
| Symptomatic Intracranial Hemorrhage | 24 hours | Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs. |
| Good Neurological Outcome at 30 Days | 30 Days Follow-up | Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more |
| Good Neurological Outcome 90 Days | 90 Days Follow-up | Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more |
Countries
United States
Participant flow
Recruitment details
Subject enrolled from Feb 2010 to Feb 2011. Subject randomized to Solitaire or Merci by baseline National Institutes of Health Stroke Scale Score.
Pre-assignment details
Study had Roll-in period. Participating centers in the United States were required to enroll two (2) roll-in subjects prior to the subject randomization. There were a total of 31 roll-in subjects. Only data from the randomized cohort was used for both primary efficacy analysis and the safety endpoint analysis.
Participants by arm
| Arm | Count |
|---|---|
| SOLITAIRE™ Device The SOLITAIRE™ Device (investigational device) is the experimental arm | 58 |
| MERCI® Device The MERCI® Device (control device) is commercially available. | 55 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 10 | 21 |
| Overall Study | Lost to Follow-up | 2 | 5 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | SOLITAIRE™ Device | MERCI® Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 33 Participants | 69 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 22 Participants | 44 Participants |
| Age, Continuous | 67.1 years STANDARD_DEVIATION 12 | 67.1 years STANDARD_DEVIATION 11.1 | 67.1 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment Europe | 1 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 57 participants | 54 participants | 111 participants |
| Sex: Female, Male Female | 30 Participants | 27 Participants | 57 Participants |
| Sex: Female, Male Male | 28 Participants | 28 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 58 | 30 / 55 |
| serious Total, serious adverse events | 49 / 58 | 44 / 55 |
Outcome results
Primary
Procedure-related Serious Adverse Events (SAEs)
Incidence of study procedure-related Serious Adverse Events (SAEs)
Time frame: 90 Day
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLITAIRE™ Device | Procedure-related Serious Adverse Events (SAEs) | 14 percentage of subjects |
| MERCI® Device | Procedure-related Serious Adverse Events (SAEs) | 16 percentage of subjects |
Primary
Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage
Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes. Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy. TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)
Time frame: Immediately post treatment
Population: Data was unavailable for two subjects from the randomized Solitaire and one from the randomized Merci cohort. Thus, the Core Lab evaluated data from 56 in the Solitaire FR group and 54 in the Merci group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLITAIRE™ Device | Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage | 60.7 Percent of Subjects |
| MERCI® Device | Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage | 24.1 Percent of Subjects |
Primary
Study Device-related Serious Adverse Events (SAEs)
Incidence of study device-related Serious Adverse Events (SAEs)
Time frame: 90 Day
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLITAIRE™ Device | Study Device-related Serious Adverse Events (SAEs) | 9 percentage of subjects |
| MERCI® Device | Study Device-related Serious Adverse Events (SAEs) | 16 percentage of subjects |
Secondary
Good Neurological Outcome 90 Days
Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more
Time frame: 90 Days Follow-up
Population: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLITAIRE™ Device | Good Neurological Outcome 90 Days | 58.2 Percent of subjects |
| MERCI® Device | Good Neurological Outcome 90 Days | 33.3 Percent of subjects |
Secondary
Good Neurological Outcome at 30 Days
Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more
Time frame: 30 Days Follow-up
Population: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLITAIRE™ Device | Good Neurological Outcome at 30 Days | 50.9 Percent of subjects |
| MERCI® Device | Good Neurological Outcome at 30 Days | 33.3 Percent of subjects |
Secondary
Mortality
Rate of Mortality
Time frame: 90 Days follow-up
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLITAIRE™ Device | Mortality | 17.2 Percentage of subjects |
| MERCI® Device | Mortality | 38.2 Percentage of subjects |
Secondary
Non-fatal Stroke-related Morbidity
Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events
Time frame: 90 Day
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLITAIRE™ Device | Non-fatal Stroke-related Morbidity | 43.1 percentage of subjects |
| MERCI® Device | Non-fatal Stroke-related Morbidity | 32.7 percentage of subjects |
Secondary
Symptomatic Intracranial Hemorrhage
Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.
Time frame: 24 hours
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLITAIRE™ Device | Symptomatic Intracranial Hemorrhage | 1.7 Percentage of subjects |
| MERCI® Device | Symptomatic Intracranial Hemorrhage | 10.9 Percentage of subjects |
Secondary
Time to Initial Recanalization
Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow
Time frame: post treatment
Population: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOLITAIRE™ Device | Time to Initial Recanalization | 47 minutes | Standard Deviation 37.3 |
| MERCI® Device | Time to Initial Recanalization | 58.7 minutes | Standard Deviation 33.8 |