Solitaire FR Thrombectomy for Acute Revascularisation "STAR"

Active, not recruiting

Phase N/A Results N/A

Eligibility Criteria

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)