Solitaire FR Thrombectomy for Acute Revascularisation (STAR)

Patients presenting acute ischemic stroke with mechanical thrombectomy treatment deemed appropriate. Consecutive evaluation.

Inclusion Criteria:

• Patient or patient's legally authorized representative received information about data collection or if mandatory, has signed and dated an Informed Consent Form
• Age ≥ 18 and < 85 years
• Clinical signs and imaging criteria consistent with acute ischemic stroke
• Thrombolysis in Cerebral Infarction TICI 0 or TICI 1 flow in 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 on set according to local stroke protocol

• If stroke presentation within 4.5hours, one of these conditions can be met:

  • Bridging protocol (starting intravenous and continuing with intra-arterial) (up to maximum 0.9mg/kg)
  • Failed Intravenous thrombolysis
  • Direct Intra-Arterial treatment (according to institution guidelines)
• Patient is willing to conduct follow-up visits
• National Institute 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 Institute 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 INR (International Normal Ratio) > 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
• 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 CT with signs of hemorrhage, avm or aneurysm
• Erly ischemic changes > 1/3 of the middle cerebral artery (MCA) territory or according to brain CT ASPECT score ≤ 6 or according to Diffusion Weighted Magnetic Resonnance Imaging (MR DWI)