Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3 "DEFUSE 3"

Terminated

Phase N/A Results N/A

Update History

9 Aug '17
The Summary of Purpose was updated.
New
This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.
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This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.
The description was updated.
New
DEFUSE 3 is a prospective randomized Phase III multicenter controlled trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion treated between 6-16 hours of stroke onset with endovascular thrombectomy therapy vs. control. The primary endpoint, the modified Rankin Score, will be assessed at 3 months. The patients' participation in the study concludes at that time (3 months from stroke onset). The study will randomize up to 476 patients over 4 years. The purpose of DEFUSE 3 is to assess the safety and efficacy of thrombectomy in carefully selected patients in an extended time window. Only the devices listed in this protocol will be used. Selection of the specific device (or devices) is determined by the individual endovascular therapist. Patients who meet the inclusion criteria will undergo either CT Perfusion/CT Angiogram or MR DWI/PWI/MRA studies prior to randomization. Patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile will be randomized in a 1:1 ratio to treatment with one or more DEFUSE 3 approved thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy versus standard medical therapy alone. Patients who are enrolled, but not randomized, will receive standard therapy according to local guidelines. Baseline data, and information about early stroke therapies, will be captured for this group of patients. Randomization of a maximum of 476 patients is planned. A novel adaptive design will identify, at interim analyses, the group with the best prospect for showing benefit from endovascular treatment, based on baseline core lesion volumes and the times since stroke onset. Interim analyses will be conducted at 200 and 340 patients, at which time the study may stop for efficacy/futility, or the inclusion criteria may be adjusted in the case of futility.
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DEFUSE 3 is a prospective randomized Phase III multicenter controlled trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion treated between 6-16 hours of stroke onset with endovascular thrombectomy therapy vs. control. The primary endpoint, the modified Rankin Score, will be assessed at 3 months. The patients' participation in the study concludes at that time (3 months from stroke onset). The study will randomize up to 476 patients over 4 years. The purpose of DEFUSE 3 is to assess the safety and efficacy of thrombectomy in carefully selected patients in an extended time window. Only the devices listed in this protocol will be used. Selection of the specific device (or devices) is determined by the individual endovascular therapist. Patients who meet the inclusion criteria will undergo either CT Perfusion/CT Angiogram or MR DWI/PWI/MRA studies prior to randomization. Patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile will be randomized in a 1:1 ratio to treatment with one or more DEFUSE 3 approved thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy versus standard medical therapy alone. Patients who are enrolled, but not randomized, will receive standard therapy according to local guidelines. Baseline data, and information about early stroke therapies, will be captured for this group of patients. Randomization of a maximum of 476 patients is planned. A novel adaptive design will identify, at interim analyses, the group with the best prospect for showing benefit from endovascular treatment, based on baseline core lesion volumes and the times since stroke onset. Interim analyses will be conducted at 200 and 340 patients, at which time the study may stop for efficacy/futility, or the inclusion criteria may be adjusted in the case of futility.
The eligibility criteria were updated.
New
Clinical Inclusion Criteria: 1. Signs & symptoms consistent w/ the diagnosis of acute anterior circulation ischemic stroke 2. Age 18-90 years 3. Baseline NIHSSS is ≥ 6 and remains ≥6 immediately prior to randomization 4. Endovascular treatment can be initiated (femoral puncture) between 6 and 16 hours of stroke onset. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline (wake-up strokes are eligible if they meet the above time limits). 5. modified Rankin Scale less than or equal to 2 prior to qualifying stroke (functionally independent for all ADLs) 6. Patient/Legally Authorized Representative has signed the Informed Consent form. Clinical Exclusion Criteria: 1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months. 2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations 3. Pregnant 4. Unable to undergo a contrast brain perfusion scan with either MRI or CT 5. Known allergy to iodine that precludes an endovascular procedure 6. Treated with tPA >4.5 hours after time last known well 7. Treated with tPA 3-4.5 hours after last known well AND any of the following; age >80, current anticoagulant use, history of diabetes or prior stroke, NIHSS >25 8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 3 (recent use of one of the new oral anticoagulants is not an exclusion if estimated GFR > 30 ml/min). 9. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS 10. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 11. Baseline platelet count < 50,000/uL 12. Severe, sustained hypertension (Systolic BP >185 mmHg or Diastolic BP >110 mmHg) 13. Current participation in another investigational drug or device study 14. Presumed septic embolus; suspicion of bacterial endocarditis 15. Clot retrieval attempted using a neurothrombectomy device prior to 6 hrs from symptom onset 16. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed. Neuroimaging Inclusion Criteria: 1. ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA AND 2. Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is >/= 1.8 and mismatch volume* is >/= 15 ml) Alternative neuroimaging inclusion criteria (if perfusion imaging or CTA/MRA is technically inadequate): A) If CTA (or MRA) is technically inadequate: Tmax>6s perfusion deficit consistent with an ICA or MCA-M1 occlusion AND Target Mismatch Profile (ischemic core volume is < 70 ml, mismatch ratio is >1.8 and mismatch volume is >15 ml as determined by RAPID software) B) If MRP is technically inadequate: ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA (or CTA, if MRA is technically inadequate and a CTA was performed within 60 minutes prior to the MRI) AND DWI lesion volume < 25 ml C) If CTP is technically inadequate: Patient can be screened with MRI and randomized if neuroimaging criteria are met. Neuroimaging Exclusion Criteria: 1. ASPECTS score <6 on non-contrast CT (if patient is enrolled based on CT perfusion criteria) 2. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation 3. Significant mass effect with midline shift 4. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection 5. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device 6. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
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Clinical Inclusion Criteria: 1. Signs & symptoms consistent w/ the diagnosis of acute anterior circulation ischemic stroke 2. Age 18-90 years 3. Baseline NIHSSS is ≥ 6 and remains ≥6 immediately prior to randomization 4. Endovascular treatment can be initiated (femoral puncture) between 6 and 16 hours of stroke onset. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline (wake-up strokes are eligible if they meet the above time limits). 5. modified Rankin Scale less than or equal to 2 prior to qualifying stroke (functionally independent for all ADLs) 6. Patient/Legally Authorized Representative has signed the Informed Consent form. Clinical Exclusion Criteria: 1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months. 2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations 3. Pregnant 4. Unable to undergo a contrast brain perfusion scan with either MRI or CT 5. Known allergy to iodine that precludes an endovascular procedure 6. Treated with tPA >4.5 hours after time last known well 7. Treated with tPA 3-4.5 hours after last known well AND any of the following; age >80, current anticoagulant use, history of diabetes or prior stroke, NIHSS >25 8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 3 (recent use of one of the new oral anticoagulants is not an exclusion if estimated GFR > 30 ml/min). 9. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS 10. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 11. Baseline platelet count < 50,000/uL 12. Severe, sustained hypertension (Systolic BP >185 mmHg or Diastolic BP >110 mmHg) 13. Current participation in another investigational drug or device study 14. Presumed septic embolus; suspicion of bacterial endocarditis 15. Clot retrieval attempted using a neurothrombectomy device prior to 6 hrs from symptom onset 16. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed. Neuroimaging Inclusion Criteria: 1. ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA AND 2. Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is >/= 1.8 and mismatch volume* is >/= 15 ml) Alternative neuroimaging inclusion criteria (if perfusion imaging or CTA/MRA is technically inadequate): A) If CTA (or MRA) is technically inadequate: Tmax>6s perfusion deficit consistent with an ICA or MCA-M1 occlusion AND Target Mismatch Profile (ischemic core volume is < 70 ml, mismatch ratio is >1.8 and mismatch volume is >15 ml as determined by RAPID software) B) If MRP is technically inadequate: ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA (or CTA, if MRA is technically inadequate and a CTA was performed within 60 minutes prior to the MRI) AND DWI lesion volume < 25 ml C) If CTP is technically inadequate: Patient can be screened with MRI and randomized if neuroimaging criteria are met. Neuroimaging Exclusion Criteria: 1. ASPECTS score <6 on non-contrast CT (if patient is enrolled based on CT perfusion criteria) 2. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation 3. Significant mass effect with midline shift 4. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection 5. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device 6. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
A location was updated in Birmingham.
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The overall status was removed for University of Alabama.
A location was updated in Fresno.
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The overall status was removed for Community Regional Medical Center.
A location was updated in La Jolla.
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The overall status was removed for Scripps Memorial Hospital.
A location was updated in La Jolla.
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The overall status was removed for UCSD Medical Center/Hillcrest Hospital.
A location was updated in Los Angeles.
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The overall status was removed for Keck Hospital of University of Southern California.
A location was updated in San Francisco.
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The overall status was removed for UCSF Medical Center, San Francisco, CA.
A location was updated in Stanford.
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The overall status was removed for Stanford University.
A location was updated in Walnut Creek.
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The overall status was removed for John Muir Medical Center.
A location was updated in Washington, D.C..
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The overall status was removed for MedStar Washington Hospital Center.
A location was updated in Chicago.
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The overall status was removed for Northwestern Memorial Hospital.
A location was updated in Iowa City.
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The overall status was removed for University of Iowa Hospital and Clinics.
A location was updated in Boston.
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The overall status was removed for Massachusetts General Hospital.
A location was updated in Boston.
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The overall status was removed for The Brigham and Women's Hospital.
A location was updated in Boston.
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The overall status was removed for Beth Israel Deaconess Medical Center.
A location was updated in Ann Arbor.
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The overall status was removed for University of Michigan Hospital.
A location was updated in Minneapolis.
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The overall status was removed for Abbott Northwestern Hospital.
A location was updated in Minneapolis.
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The overall status was removed for Hennepin County Medical Center.
A location was updated in Minneapolis.
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The overall status was removed for University of Minnesota Medical Center, Fairview.
A location was updated in Ridgewood.
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The overall status was removed for The Valley Hospital.
A location was updated in New York.
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The overall status was removed for Mount Sinai Hospital.
A location was updated in New York.
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The overall status was removed for New York Presbyterian Hospital at Columbia.
A location was updated in New York.
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The overall status was removed for NYP Weill Cornell Medical Center.
A location was updated in Cincinnati.
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The overall status was removed for University of Cincinnati.
A location was updated in Cleveland.
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The overall status was removed for Cleveland Clinic.
A location was updated in Columbus.
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The overall status was removed for Ohio State University Wexner Medical Center.
A location was updated in Toledo.
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The overall status was removed for Mercy Health St. Vincent Medical Center.
A location was updated in Portland.
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The overall status was removed for Providence St. Vincent Medical Center.
A location was updated in Portland.
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The overall status was removed for Oregon Health & Science University Hospital.
A location was updated in Philadelphia.
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The overall status was removed for Hospital of the University of Pennsylvania.
A location was updated in Philadelphia.
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The overall status was removed for Temple University Hospital.
A location was updated in Providence.
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The overall status was removed for Rhode Island Hospital.
A location was updated in Columbia.
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The overall status was removed for Palmetto Health Richland.
A location was updated in Nashville.
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The overall status was removed for Vanderbilt University.
A location was updated in Austin.
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The overall status was removed for University Medical Center Brackenridge.
A location was updated in Austin.
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The overall status was removed for Seton Medical Center/UT Southwestern.
A location was updated in Houston.
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The overall status was removed for Memorial Hermann Texas Medical Center.
A location was updated in Salt Lake City.
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The overall status was removed for Intermountain Medical Center.
A location was updated in Salt Lake City.
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The overall status was removed for University of Utah Healthcare.
A location was updated in Seattle.
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The overall status was removed for Harborview Medical Center.
A location was updated in Madison.
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The overall status was removed for University of Wisconsin.
29 Apr '17
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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Clinical Inclusion Criteria: 1. Signs & symptoms consistent w/ the diagnosis of acute anterior circulation ischemic stroke 2. Age 18-90 years 3. Baseline NIHSSS is ≥ 6 and remains ≥6 immediately prior to randomization 4. Endovascular treatment can be initiated (femoral puncture) between 6 and 16 hours of stroke onset. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline (wake-up strokes are eligible if they meet the above time limits). 5. modified Rankin Scale less than or equal to 2 prior to qualifying stroke (functionally independent for all ADLs) 6. Patient/Legally Authorized Representative has signed the Informed Consent form. Clinical Exclusion Criteria: 1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months. 2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations 3. Pregnant 4. Unable to undergo a contrast brain perfusion scan with either MRI or CT 5. Known allergy to iodine that precludes an endovascular procedure 6. Treated with tPA >4.5 hours after time last known well 7. Treated with tPA 3-4.5 hours after last known well AND any of the following; age >80, current anticoagulant use, history of diabetes or prior stroke, NIHSS >25 8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 3 (recent use of one of the new oral anticoagulants is not an exclusion if estimated GFR > 30 ml/min). 9. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS 10. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 11. Baseline platelet count < 50,000/uL 12. Severe, sustained hypertension (Systolic BP >185 mmHg or Diastolic BP >110 mmHg) 13. Current participation in another investigational drug or device study 14. Presumed septic embolus; suspicion of bacterial endocarditis 15. Clot retrieval attempted using a neurothrombectomy device prior to 6 hrs from symptom onset 16. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed. Neuroimaging Inclusion Criteria: 1. ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA AND 2. Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is >/= 1.8 and mismatch volume* is >/= 15 ml) Alternative neuroimaging inclusion criteria (if perfusion imaging or CTA/MRA is technically inadequate): A) If CTA (or MRA) is technically inadequate: Tmax>6s perfusion deficit consistent with an ICA or MCA-M1 occlusion AND Target Mismatch Profile (ischemic core volume is < 70 ml, mismatch ratio is >1.8 and mismatch volume is >15 ml as determined by RAPID software) B) If MRP is technically inadequate: ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA (or CTA, if MRA is technically inadequate and a CTA was performed within 60 minutes prior to the MRI) AND DWI lesion volume < 25 ml C) If CTP is technically inadequate: Patient can be screened with MRI and randomized if neuroimaging criteria are met. Neuroimaging Exclusion Criteria: 1. ASPECTS score <6 on non-contrast CT (if patient is enrolled based on CT perfusion criteria) 2. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation 3. Significant mass effect with midline shift 4. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection 5. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device 6. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
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Clinical Inclusion Criteria: 1. Signs & symptoms consistent w/ the diagnosis of acute anterior circulation ischemic stroke 2. Age 18-90 years 3. Baseline NIHSSS is ≥ 6 and remains ≥6 immediately prior to randomization 4. Endovascular treatment can be initiated (femoral puncture) between 6 and 16 hours of stroke onset. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline (wake-up strokes are eligible if they meet the above time limits). 5. modified Rankin Scale less than or equal to 2 prior to qualifying stroke (functionally independent for all ADLs) 6. Patient/Legally Authorized Representative has signed the Informed Consent form. Clinical Exclusion Criteria: 1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months. 2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations 3. Pregnant 4. Unable to undergo a contrast brain perfusion scan with either MRI or CT 5. Known allergy to iodine that precludes an endovascular procedure 6. Treated with tPA >4.5 hours after time last known well 7. Treated with tPA 3-4.5 hours after last known well AND any of the following; age >80, current anticoagulant use, history of diabetes or prior stroke, NIHSS >25 8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 3 (recent use of one of the new oral anticoagulants is not an exclusion if estimated GFR > 30 ml/min). 9. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS 10. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 11. Baseline platelet count < 50,000/uL 12. Severe, sustained hypertension (Systolic BP >185 mmHg or Diastolic BP >110 mmHg) 13. Current participation in another investigational drug or device study 14. Presumed septic embolus; suspicion of bacterial endocarditis 15. Clot retrieval attempted using a neurothrombectomy device prior to 6 hrs from symptom onset Neuroimaging Inclusion Criteria: 1. ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA AND 2. Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is >/= 1.8 and mismatch volume* is >/= 15 ml) Alternative neuroimaging inclusion criteria (if perfusion imaging or CTA/MRA is technically inadequate): A) If CTA (or MRA) is technically inadequate: Tmax>6s perfusion deficit consistent with an ICA or MCA-M1 occlusion AND Target Mismatch Profile (ischemic core volume is < 70 ml, mismatch ratio is >1.8 and mismatch volume is >15 ml as determined by RAPID software) B) If MRP is technically inadequate: ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA (or CTA, if MRA is technically inadequate and a CTA was performed within 60 minutes prior to the MRI) AND DWI lesion volume < 25 ml C) If CTP is technically inadequate: Patient can be screened with MRI and randomized if neuroimaging criteria are met. Neuroimaging Exclusion Criteria: 1. ASPECTS score <6 on non-contrast CT (if baseline non-contrast CT was performed) 2. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation 3. Significant mass effect with midline shift 4. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection 5. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device 6. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
15 Apr '16
The eligibility criteria were updated.
New
Clinical Inclusion Criteria: 1. Signs & symptoms consistent w/ the diagnosis of acute anterior circulation ischemic stroke 2. Age 18-90 years 3. Baseline NIHSSS is ≥ 6 and remains ≥6 immediately prior to randomization 4. Endovascular treatment can be initiated (femoral puncture) between 6 and 16 hours of stroke onset. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline (wake-up strokes are eligible if they meet the above time limits). 5. modified Rankin Scale less than or equal to 2 prior to qualifying stroke (functionally independent for all ADLs) 6. Patient/Legally Authorized Representative has signed the Informed Consent form. Clinical Exclusion Criteria: 1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months. 2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations 3. Pregnant 4. Unable to undergo a contrast brain perfusion scan with either MRI or CT 5. Known allergy to iodine that precludes an endovascular procedure 6. Treated with tPA >4.5 hours after time last known well 7. Treated with tPA 3-4.5 hours after last known well AND any of the following; age >80, current anticoagulant use, history of diabetes or prior stroke, NIHSS >25 8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 3 (recent use of one of the new oral anticoagulants is not an exclusion if estimated GFR > 30 ml/min). 9. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS 10. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 11. Baseline platelet count < 50,000/uL 12. Severe, sustained hypertension (Systolic BP >185 mmHg or Diastolic BP >110 mmHg) 13. Current participation in another investigational drug or device study 14. Presumed septic embolus; suspicion of bacterial endocarditis 15. Clot retrieval attempted using a neurothrombectomy device prior to 6 hrs from symptom onset Neuroimaging Inclusion Criteria: 1. ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA AND 2. Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is >/= 1.8 and mismatch volume* is >/= 15 ml) Alternative neuroimaging inclusion criteria (if perfusion imaging or CTA/MRA is technically inadequate): A) If CTA (or MRA) is technically inadequate: Tmax>6s perfusion deficit consistent with an ICA or MCA-M1 occlusion AND Target Mismatch Profile (ischemic core volume is < 70 ml, mismatch ratio is >1.8 and mismatch volume is >15 ml as determined by RAPID software) B) If MRP is technically inadequate: ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA (or CTA, if MRA is technically inadequate and a CTA was performed within 60 minutes prior to the MRI) AND DWI lesion volume < 25 ml C) If CTP is technically inadequate: Patient can be screened with MRI and randomized if neuroimaging criteria are met. Neuroimaging Exclusion Criteria: 1. ASPECTS score <6 on non-contrast CT (if baseline non-contrast CT was performed) 2. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation 3. Significant mass effect with midline shift 4. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection 5. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device 6. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
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Inclusion Criteria: - Clinical Inclusion Criteria: 1. Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke 2. Age 18-85 years 3. Baseline NIHSSS is ≥ 6 and remains ≥6 immediately prior to randomization 4. Able to undergo an MRI or CT Perfusion within 90 minutes of arrival at the study site. 5. Endovascular treatment can be initiated (femoral puncture) between 6 and 16 hours of stroke onset. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline (wake-up strokes are eligible if they meet the above time limits). 6. No significant pre-stroke disability (pre-baseline modified Rankin Scale score 0-2) 7. Patient willing/able to return for protocol required follow up visits 8. Patient/Legally Authorized Representative has signed the Informed Consent form. - Neuroimaging Inclusion Criteria: 1. ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA AND 2. Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is > 1.8 and mismatch volume* is > 15 ml) - Alternative neuroimaging inclusion criteria (if perfusion imaging or CTA/MRA is technically inadequate): 1. If CTA (or MRA) is technically inadequate: Tmax>6s perfusion deficit consistent with an ICA or MCA-M1 occlusion AND Target Mismatch Profile (ischemic core volume is < 70 ml, mismatch ratio is >1.8 and mismatch volume is >15 ml as determined by RAPID software) 2. If MRP is technically inadequate: ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA (or CTA, if MRA is technically inadequate and a CTA was performed within 60 minutes prior to the MRI) AND DWI lesion volume < 25 ml 3. If CTP is technically inadequate: Patient can be screened with MRI and enrolled if neuroimaging criteria are met. Exclusion Criteria: - Clinical Exclusion Criteria: 1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months. 2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations or patient is already participating in another drug or device study 3. Pregnancy 4. Contraindication for MRI (e.g. pacemaker, severe claustrophobia) 5. Contraindications for both MRI and CT contrast precluding an MRI or CT contrast perfusion study. The hospital's local standard criteria should be applied to determine if contraindications exist 6. Known allergy to iodine and previously refractory to pretreatment medications 7. Treated with tPA >4.5 hours after time last known well 8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 3 (recent use of one of the new oral anticoagulants is not an exclusion if eGFR > 30 ml/min). 9. Symptoms consistent with stroke in multiple locations. 10. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment 11. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 12. Baseline platelet count < 50,000/uL 13. Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg) not treatable with medications. 14. Current participation in another investigational drug or device study or registry 15. Presumed septic embolus; suspicion of bacterial endocarditis or cerebral vasculitis 16. Subjects who have had clot retrieval attempted using a neurothrombectomy device prior to 6 hours from symptom onset
A location was updated in Stanford.
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The overall status was removed for Stanford University.