Solitaire FR Thrombectomy for Acute Revascularisation

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.

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