Solitaire FR Thrombectomy for Acute Revascularisation

Study Overview
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Brief Summary
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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
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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.

Official Title
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STAR: Solitaire FR Thrombectomy for Acute Revascularisation

Conditions
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Stroke, Acute

Intervention / Treatment
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* Device: Solitaire™ FR device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject or subject's legally authorized representative has signed and dated an Informed Consent Form Age ≥ 18 and < 85 Clinical signs consistent with acute ischemic stroke 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) Presentation within 8 hours of stroke onset according to local stroke protocol 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) Subject is willing to conduct follow-up visits. National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30 Modified Rankin Scale (mRS) ≤ 2 prior to stroke onset Exclusion Criteria: Females who are pregnant or lactating Known serious sensitivity to radiographic contrast agents Neurological signs that are rapidly improving prior to or at time of treatment Current participation in another investigational drug or device study Life expectancy of less than 90 days National Institutes of Health Stroke Scale (NIHSS) > 30 or coma 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 Normalised Ratio (INR) > 3.0 Platelet count < 30,000 Glucose < 400 mg/dL Previous stroke within 30 days Time of symptom onset unknown Seizure at the onset of stroke Myocardial infarction or infection (sepsis or endocarditis) Arterial tortuosity that would prevent the device from reaching the target vessel Known hypersensitivity to nickel-titanium Imaging Exclusion Criteria: Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis Stenosis proximal to thrombus site that may preclude safe recovery of the device Brain computed tomography (CT) with signs of hemorrhage, arteriovenous venous malformations, or aneurysm Early ischemic changes greater than 1/3 of the middle cerebral artery (MCA) territory or according to brain computed tomography (CT) Alberta Stroke Program Early CT (ASPECT) score ≤ 6 or according to magnetic resonance diffusion weighted imaging (MR DWI) ASPECT score <5

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Solitaire™ FR device<br>Eligible subjects treated with the Solitaire™ FR device. | Device: Solitaire™ FR device<br>* Mechanical Thrombectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Immediately post procedure | 
| 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. | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During procedure | 
| 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 | During Procedure | 
| 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 | 90 Days | 
| Rate of Morbidity |  | 90 Days | 
| Rate of Mortality |  | 90 Days | 
| 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 | 24 hours | 
| 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 | procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solitaire FR Device, Mechanical Thrombectomy, Recanalization, Brain artery recanalization, Neurovascular intervention, Interventional Neuroradiology, STAR, Acute Ischemic Stroke