Solitaire FR Thrombectomy for Acute Revascularisation "STAR"

Active, not recruiting

Phase N/A Results N/A

Update History

27 Jun '12
A location was updated in Bern.
New
The overall status was removed for Inselspital University Hospital of Bern.
A location was updated in Geneva.
New
The overall status was removed for Hôpitaux Universitaires de Genève (HUG).
6 Oct '11
The eligibility criteria were updated.
New
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)
Old
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)