Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke "Re-ACT"

Completed

Phase N/A Results N/A

Update History

9 Aug '17
The Summary of Purpose was updated.
New
The main objective of this study is to assess the safety and effectiveness of the ReVive SE (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when used according to its Instruction for use (IFU).
Old
The main objective of this study is to assess the safety and effectiveness of the ReVive SE (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when used according to its Instruction for use (IFU).
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Age ≥ 18 years old 2. Clinical signs consistent with acute ischemic stroke 3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1) 4. NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE 5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE. 6. Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours 7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented Exclusion Criteria: 1. Life expectancy of less than 90 days 2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation) 3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke 4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent) 5. Known bleeding diathesis: 1. Current use of oral anticoagulants (eg, warfarin sodium) with International Normalized Ratio (INR) > 3; 2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or 3. Platelet count < 100,000/mm3 6. Glucose <50 mg/dL (2.8 mmol, 2.6mM) 7. Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management 8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents 9. Pregnancy or lactating female 10. Subject already enrolled in a clinical study involving experimental medication or device Imaging Exclusion criteria: 11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor. 12. Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis 13. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
Old
Inclusion Criteria: 1. Age ≥ 18 years old 2. Clinical signs consistent with acute ischemic stroke 3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1) 4. NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE 5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE. 6. Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours 7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented Exclusion Criteria: 1. Life expectancy of less than 90 days 2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation) 3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke 4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent) 5. Known bleeding diathesis: 1. Current use of oral anticoagulants (eg, warfarin sodium) with International Normalized Ratio (INR) > 3; 2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or 3. Platelet count < 100,000/mm3 6. Glucose <50 mg/dL (2.8 mmol, 2.6mM) 7. Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management 8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents 9. Pregnancy or lactating female 10. Subject already enrolled in a clinical study involving experimental medication or device Imaging Exclusion criteria: 11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor. 12. Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis 13. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
26 Apr '17
The gender criteria for eligibility was updated to "All."
A location was updated in Bordeaux.
New
The overall status was removed for CHU Bordeaux.
A location was updated in Clermont Ferrand.
New
The overall status was removed for CHU Clermont Ferrand.
A location was updated in Colmar.
New
The overall status was removed for CHU de Colmar.
A location was updated in Dijon.
New
The overall status was removed for CHU Dijon.
A location was updated in Lille.
New
The overall status was removed for CHU Lille.
A location was updated in Marseille.
New
The overall status was removed for CHU La Timone.
A location was updated in St Etienne.
New
The overall status was removed for CHU St Etienne.
A location was updated in Tours.
New
The overall status was removed for Hôpital Bretonneau.
23 Sep '16
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Age ≥ 18 years old 2. Clinical signs consistent with acute ischemic stroke 3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1) 4. NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE 5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE. 6. Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours 7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented Exclusion Criteria: 1. Life expectancy of less than 90 days 2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation) 3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke 4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent) 5. Known bleeding diathesis: 1. Current use of oral anticoagulants (eg, warfarin sodium) with International Normalized Ratio (INR) > 3; 2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or 3. Platelet count < 100,000/mm3 6. Glucose <50 mg/dL (2.8 mmol, 2.6mM) 7. Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management 8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents 9. Pregnancy or lactating female 10. Subject already enrolled in a clinical study involving experimental medication or device Imaging Exclusion criteria: 11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor. 12. Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis 13. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
Old
Inclusion Criteria: 1. Age ≥ 18 years old 2. Clinical signs consistent with acute ischemic stroke 3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1) 4. NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE 5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE. 6. Treatment initiated within 6 hours after symptom onset (first ReVive SE pass made within 6 hours 7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented Exclusion Criteria: 1. Life expectancy of less than 90 days 2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation) 3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke 4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent) 5. Known bleeding diathesis: 1. Current use of oral anticoagulants (eg, warfarin sodium) or with International Normalized Ratio (INR) > 3; 2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or 3. Platelet count < 100,000/mm3 6. Glucose <50 mg/dL (2.8 mmol, 2.6mM) 7. Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management 8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents 9. Pregnancy or lactating female 10. Subject already enrolled in a clinical study involving experimental medication or device Imaging Exclusion criteria: 11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor. 12. Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis 13. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
A location was updated in St Etienne.
New
The overall status was removed for CHU St Etienne.
A location was updated in Tours.
New
The overall status was removed for Hôpital Bretonneau.
7 Jul '16
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Age ≥ 18 years old 2. Clinical signs consistent with acute ischemic stroke 3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1) 4. NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE 5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE. 6. Treatment initiated within 6 hours after symptom onset (first ReVive SE pass made within 6 hours 7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented Exclusion Criteria: 1. Life expectancy of less than 90 days 2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation) 3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke 4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent) 5. Known bleeding diathesis: 1. Current use of oral anticoagulants (eg, warfarin sodium) or with International Normalized Ratio (INR) > 3; 2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or 3. Platelet count < 100,000/mm3 6. Glucose <50 mg/dL (2.8 mmol, 2.6mM) 7. Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management 8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents 9. Pregnancy or lactating female 10. Subject already enrolled in a clinical study involving experimental medication or device Imaging Exclusion criteria: 11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor. 12. Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis 13. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
Old
Inclusion Criteria: 1. Age 18-80 years old 2. Clinical signs consistent with acute ischemic stroke 3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1) 4. NIHSS >8 and <25, assessed within two hours before treatment with ReVive SE 5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE. 6. Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours), one of these condition can be met: 1. Rescue protocol (in case of failed IV fibrinolysis), or 2. Bridging protocol (IV fibrinolysis followed by IA thrombectomy with ReVive SE) 3. Immediately if no standard IV thrombolysis therapy possible due to a contra-indication for IV thrombolysis 7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented Exclusion Criteria: 1. Life expectancy of less than 90 days 2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation) 3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke 4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent) 5. Known bleeding diathesis: 1. Current use of oral anticoagulants (eg, warfarin sodium) or with International Normalized Ratio (INR) > 1.7; 2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or 3. Platelet count < 100,000/mm3 6. Glucose <50 mg/dL (2.8 mmol, 2.6mM) 7. Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management 8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents 9. Pregnancy or lactating female 10. Subject already enrolled in a clinical study involving experimental medication or device Imaging Exclusion criteria: 11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor. 12. For MCA strokes, CT scan showing hypodensity or MRI showing restricted diffusion involving greater than 1/3 of the MCA territory (or ASPECT score ≤ 7) on presentation. For dICA and/or BA strokes, the hypodensity on CT or restricted diffusion on MR involving > 100cc of tissue on presentation. 13. Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis 14. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
11 Feb '16
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Age 18-80 years old 2. Clinical signs consistent with acute ischemic stroke 3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1) 4. NIHSS >8 and <25, assessed within two hours before treatment with ReVive SE 5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE. 6. Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours), one of these condition can be met: 1. Rescue protocol (in case of failed IV fibrinolysis), or 2. Bridging protocol (IV fibrinolysis followed by IA thrombectomy with ReVive SE) 3. Immediately if no standard IV thrombolysis therapy possible due to a contra-indication for IV thrombolysis 7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented Exclusion Criteria: 1. Life expectancy of less than 90 days 2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation) 3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke 4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent) 5. Known bleeding diathesis: 1. Current use of oral anticoagulants (eg, warfarin sodium) or with International Normalized Ratio (INR) > 1.7; 2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or 3. Platelet count < 100,000/mm3 6. Glucose <50 mg/dL (2.8 mmol, 2.6mM) 7. Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management 8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents 9. Pregnancy or lactating female 10. Subject already enrolled in a clinical study involving experimental medication or device Imaging Exclusion criteria: 11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor. 12. For MCA strokes, CT scan showing hypodensity or MRI showing restricted diffusion involving greater than 1/3 of the MCA territory (or ASPECT score ≤ 7) on presentation. For dICA and/or BA strokes, the hypodensity on CT or restricted diffusion on MR involving > 100cc of tissue on presentation. 13. Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis 14. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
Old
Inclusion Criteria: 1. Age 18-80 years old 2. Clinical signs consistent with acute ischemic stroke 3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1) 4. NIHSS >8 and <25, assessed within two hours before treatment with ReVive SE 5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE. 6. Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours), one of these condition can be met: 1. Rescue protocol (in case of failed IV fibrinolysis), or 2. Bridging protocol (IV fibrinolysis followed by IA thrombectomy with ReVive SE) 3. Immediately if no standard IV thrombolysis therapy possible due to a contra-indication for IV thrombolysis 7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented Exclusion Criteria: 1. Life expectancy of less than 90 days 2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation) 3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke 4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent) 5. Known bleeding diathesis: 1. Current use of oral anticoagulants (eg, warfarin sodium) or with International Normalized Ratio (INR) > 1.7; 2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or 3. Platelet count < 100,000/mm3 6. Glucose <50 mg/dL (2.8 mmol, 2.6mM) 7. Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management 8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents 9. Pregnancy or lactating female 10. Subject already enrolled in a clinical study involving experimental medication or device Imaging Exclusion criteria: 11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor. 12. For MCA strokes, CT scan showing hypodensity or MRI showing restricted diffusion involving greater than 1/3 of the MCA territory (or ASPECT score ≤ 7) on presentation. For dICA and/or BA strokes, the hypodensity on CT or restricted diffusion on MR involving > 100cc of tissue on presentation. 13. Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis 14. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
28 Aug '15
A location was updated in Bordeaux.
New
The overall status was removed for CHU Bordeaux.
A location was updated in Clermont Ferrand.
New
The overall status was removed for CHU Clermont Ferrand.
A location was updated in Colmar.
New
The overall status was removed for CHU de Colmar.
A location was updated in Dijon.
New
The overall status was removed for CHU Dijon.
A location was updated in St Etienne.
New
The overall status was removed for CHU St Etienne.
5 Feb '15
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Age 18-80 years old 2. Clinical signs consistent with acute ischemic stroke 3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1) 4. NIHSS >8 and <25, assessed within two hours before treatment with ReVive SE 5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE. 6. Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours), one of these condition can be met: 1. Rescue protocol (in case of failed IV fibrinolysis), or 2. Bridging protocol (IV fibrinolysis followed by IA thrombectomy with ReVive SE) 3. Immediately if no standard IV thrombolysis therapy possible due to a contra-indication for IV thrombolysis 7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented Exclusion Criteria: 1. Life expectancy of less than 90 days 2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation) 3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke 4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent) 5. Known bleeding diathesis: 1. Current use of oral anticoagulants (eg, warfarin sodium) or with International Normalized Ratio (INR) > 1.7; 2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or 3. Platelet count < 100,000/mm3 6. Glucose <50 mg/dL (2.8 mmol, 2.6mM) 7. Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management 8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents 9. Pregnancy or lactating female 10. Subject already enrolled in a clinical study involving experimental medication or device Imaging Exclusion criteria: 11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor. 12. For MCA strokes, CT scan showing hypodensity or MRI showing restricted diffusion involving greater than 1/3 of the MCA territory (or ASPECT score ≤ 7) on presentation. For dICA and/or BA strokes, the hypodensity on CT or restricted diffusion on MR involving > 100cc of tissue on presentation. 13. Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis 14. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
Old
Inclusion Criteria: 1. Age 18-80 years old 2. Clinical signs consistent with acute ischemic stroke 3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1) 4. NIHSS >8 and <30, assessed within two hours before treatment with ReVive SE 5. Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE. 6. Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 8 hours), one of these condition can be met: 1. Rescue protocol (in case of failed IV fibrinolysis), or 2. Bridging protocol (IV fibrinolysis followed by IA thrombectomy with ReVive SE) 3. Immediately if no standard IV thrombolysis therapy possible due to a contra-indication for IV thrombolysis 7. Subject or legally authorized representative has provided informed consent on data collection, and consent is documented Exclusion Criteria: 1. Life expectancy of less than 90 days 2. Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation) 3. Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke 4. Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent) 5. Known bleeding diathesis: 1. Current use of oral anticoagulants (eg, warfarin sodium) or with International Normalized Ratio (INR) > 1.7; 2. Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or 3. Platelet count < 100,000/mm3 6. Glucose <50 mg/dL (2.8 mmol, 2.6mM) 7. Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management 8. Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents 9. Pregnancy or lactating female 10. Subject already enrolled in a clinical study involving experimental medication or device Imaging Exclusion criteria: 11. CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor. 12. For MCA strokes, CT scan showing hypodensity or MRI showing restricted diffusion involving greater than 1/3 of the MCA territory (or ASPECT score ≤ 7) on presentation. For dICA and/or BA strokes, the hypodensity on CT or restricted diffusion on MR involving > 100cc of tissue on presentation. 13. Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis 14. Blood vessel with extreme tortuosity or other conditions preventing the access of the device.