Stroke, Acute
Conditions
Keywords
Solitaire FR Device, Mechanical Thrombectomy, Recanalization, Brain artery recanalization, Neurovascular intervention, Interventional Neuroradiology, STAR, Acute Ischemic Stroke
Brief summary
The objective of this study was to obtain prospective clinical data on the safety and efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke.
Detailed description
The Study was a multi-center, single-arm, prospective, observational evaluation. The Solitaire™ FR Device has been certified for CE mark. This protocol evaluated the safety and efficacy of the Solitaire™ FR Device when used in routine practice and according to its Instructions for Use.
Interventions
DEVICESolitaire™ FR device
Mechanical Thrombectomy
Sponsors
ev3 International
Medtronic Neurovascular Clinical Affairs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
1. Subject or subject's legally authorized representative has signed and dated an Informed Consent Form 2. Age ≥ 18 and \< 85 3. Clinical signs consistent with acute ischemic stroke 4. Thrombolysis in Cerebral Infarction (TICI) 0 or TICI 1 flow in the proximal anterior intracranial vasculature (M1 or M2 of Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) intracranial, Internal Carotid Artery (ICA) terminal) 5. Presentation within 8 hours of stroke onset according to local stroke protocol 6. If stroke presentation within 4.5 hours, one of these conditions can be met: * Bridging protocol (starting intravenous and continuing with intra-arterial) (Up to maximum 0.9 mg/kg) * Failed intravenous thrombolysis * Direct Intra-arterial treatment (according to institution guidelines) 7. Subject is willing to conduct follow-up visits. 8. National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30 9. Modified Rankin Scale (mRS) ≤ 2 prior to stroke onset
Exclusion criteria
1. Females who are pregnant or lactating 2. Known serious sensitivity to radiographic contrast agents 3. Neurological signs that are rapidly improving prior to or at time of treatment 4. Current participation in another investigational drug or device study 5. Life expectancy of less than 90 days 6. National Institutes of Health Stroke Scale (NIHSS) \> 30 or coma 7. Uncontrolled hypertension defined as systolic blood pressure \> 185 or diastolic blood pressure \> 110 that cannot be controlled except with continuous parenteral antihypertensive medication 8. Use of warfarin anticoagulation with International Normalised Ratio (INR) \> 3.0 9. Platelet count \< 30,000 10. Glucose \< 400 mg/dL 11. Previous stroke within 30 days 12. Time of symptom onset unknown 13. Seizure at the onset of stroke 14. Myocardial infarction or infection (sepsis or endocarditis) 15. Arterial tortuosity that would prevent the device from reaching the target vessel 16. Known hypersensitivity to nickel-titanium Imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device. | Immediately post procedure | Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion |
| Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs). | 90 Days | Device-related and procedure-related Serious Adverse Events (SAEs). A clinically significant procedure complication is defined as a decline in NIHSS of ≥4 or access vessel complication requiring surgery or blood transfusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Good Neurological Condition | 90 Days | Good neurological outcome (GNO), as defined in the protocol, is a modified Rankin Scale (mRS) score of less than or equal to 2, or National Institutes of Health Stroke Scale (NIHSS) score 0-1, or NIHSS score improvement of 10 points or more from the pre-procedure evaluation |
| Rate of Morbidity | 90 Days | — |
| Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram | During procedure | Time from groin stick to initial angiogram and final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion |
| Incidence of Symptomatic Intracranial Hemorrhage | 24 hours | Symptomatic intracranial hemorrhage, 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 decline in National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24 hrs. PH1 - Hematoma within ischemic field with some mild space occupying effect but involving ≤ 30% PH2 - Hematoma within ischemic field with space-occupying effect involving \> 30% of the infarcted area RIH - Any intraparenchymal hemorrhage remote from the ischemic field IVH - Intraventricular hemorrhage SAH - Subarachnoid hemorrhage |
| Immediate Flow Reperfusion | procedure | Immediate reperfusion observed when the Solitaire™ FR device is deployed within the thrombus - Thrombolysis in Cerebral Infarction (TICI) score 2b or 3. Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion |
| Rate of Mortality | 90 Days | — |
| Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram | During Procedure | Time after first ipsilateral angiogram to final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Solitaire™ FR Device Eligible subjects treated with the Solitaire™ FR device. | 202 |
| Total | 202 |
Baseline characteristics
| Characteristic | Solitaire™ FR Device |
|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 12.5 |
| Gender Female | 122 Participants |
| Gender Male | 80 Participants |
| Modified Rankin Scale (mRS) | 0.0 Scores on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 143 / 202 |
| serious Total, serious adverse events | 59 / 202 |
Outcome results
Primary
Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device.
Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion
Time frame: Immediately post procedure
Population: Due to insufficient imaging, the Core Lab was able to evaluate data from 190 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solitaire™ FR Device | Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device. | 84.2 percentage of particpants |
Primary
Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs).
Device-related and procedure-related Serious Adverse Events (SAEs). A clinically significant procedure complication is defined as a decline in NIHSS of ≥4 or access vessel complication requiring surgery or blood transfusion.
Time frame: 90 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solitaire™ FR Device | Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs). | 7.4 percentage of events |
Secondary
Good Neurological Condition
Good neurological outcome (GNO), as defined in the protocol, is a modified Rankin Scale (mRS) score of less than or equal to 2, or National Institutes of Health Stroke Scale (NIHSS) score 0-1, or NIHSS score improvement of 10 points or more from the pre-procedure evaluation
Time frame: 90 Days
Population: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solitaire™ FR Device | Good Neurological Condition | 88.2 percentage of particpants |
Secondary
Immediate Flow Reperfusion
Immediate reperfusion observed when the Solitaire™ FR device is deployed within the thrombus - Thrombolysis in Cerebral Infarction (TICI) score 2b or 3. Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion
Time frame: procedure
Population: Due to insufficient imaging, the Core Lab was able to evaluated data from 190 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solitaire™ FR Device | Immediate Flow Reperfusion | 11.6 percentage of participants |
Secondary
Incidence of Symptomatic Intracranial Hemorrhage
Symptomatic intracranial hemorrhage, 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 decline in National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24 hrs. PH1 - Hematoma within ischemic field with some mild space occupying effect but involving ≤ 30% PH2 - Hematoma within ischemic field with space-occupying effect involving \> 30% of the infarcted area RIH - Any intraparenchymal hemorrhage remote from the ischemic field IVH - Intraventricular hemorrhage SAH - Subarachnoid hemorrhage
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solitaire™ FR Device | Incidence of Symptomatic Intracranial Hemorrhage | 1.5 percentage of particpants |
Secondary
Rate of Morbidity
Time frame: 90 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solitaire™ FR Device | Rate of Morbidity | 8.4 percentage of particpants |
Secondary
Rate of Mortality
Time frame: 90 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solitaire™ FR Device | Rate of Mortality | 6.9 percentage of particpants |
Secondary
Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram
Time after first ipsilateral angiogram to final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion
Time frame: During Procedure
Population: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solitaire™ FR Device | Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram | 37.2 Minutes | Standard Deviation 57.7 |
Secondary
Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram
Time from groin stick to initial angiogram and final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion
Time frame: During procedure
Population: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solitaire™ FR Device | Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram | 29 Minutes | Standard Deviation 27 |