| Primary | Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS) | Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a "good" functional outcome with a score ranging from 0-2. The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, (patients seen within 6 hours of symptom onset will be immediately considered for endovascular therapy according to the site's standard of care. Likewise, patients presenting beyond 12 hours will be treated according to the site's standard of care), with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT. | | Posted | | Number | | percentage of participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Best Medical Therapy | Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:
- General medical management according to AHA/ASA guidelines
- Admission to monitored or intensive care unit for at least 24 hours
- Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient
- Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician
- Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines
- Follow-up imaging study required in any patient with neurologic deterioration
| | OG001 | Endovascular Treatment | Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination. Endovascular Mechanical Thrombectomy: Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revas |
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| Secondary | Percentage of Participants in the 6-12 hr Cohort With Global Disability as Assessed by the Modified Rankin Score (mRS) | The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A score of 3-6 represents global disability are defined as follows: (3) moderate disability (requiring some help, but able to walk without assistance); (4) moderate severe disability (unable to walk without assistance and unable to attend to own bodily needs without assistance); (5) severe disability (bedridden, incontinent and requiring constant nursing care and attention; and (6) dead. | There were only 12 participants total in the 6-12hr cohort | Posted | | Number | | percentage of participants | | 90 day | | | | ID | Title | Description |
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| OG000 | Best Medical Therapy | Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:
- General medical management according to AHA/ASA guidelines
- Admission to monitored or intensive care unit for at least 24 hours
- Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient
- Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician
- Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines
- Follow-up imaging study required in any patient with neurologic deterioration
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| Secondary | Percentage of Participants in the 6-12hr Cohort With Good Functional Recovery as Assessed by the Modified Rankin Scale (mRS) | The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A score of 0-2 represents good functional recovery. The scores are defined as follows: (0) No symptoms at all; (1) No significant disability despite symptoms, able to carry out all usual duties and activities; (2) Slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance. | | Posted | | Number | | Percentage of particpants | | 90 days | | | | ID | Title | Description |
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| OG000 | Best Medical Therapy | Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:
- General medical management according to AHA/ASA guidelines
- Admission to monitored or intensive care unit for at least 24 hours
- Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient
- Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician
- Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines
- Follow-up imaging study required in any patient with neurologic deterioration
| | OG001 |
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| Secondary | Percentage of Participants Mortality at 30 Days | Mortality at 30 days will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected. | The values for 4 subjects was not captured at this timepoint | Posted | | Number | | percentage of participants | | 30 days | | | | ID | Title | Description |
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| OG000 | Best Medical Therapy | Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:
- General medical management according to AHA/ASA guidelines
- Admission to monitored or intensive care unit for at least 24 hours
- Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient
- Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician
- Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines
- Follow-up imaging study required in any patient with neurologic deterioration
| | OG001 | Endovascular Treatment |
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| Secondary | Percentage of Participants Mortality at 90 Days | Mortality at 90 days will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected. | | Posted | | Number | | percentage of participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Best Medical Therapy | Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:
- General medical management according to AHA/ASA guidelines
- Admission to monitored or intensive care unit for at least 24 hours
- Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient
- Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician
- Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines
- Follow-up imaging study required in any patient with neurologic deterioration
| | OG001 | Endovascular Treatment | Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination. |
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| Secondary | Percentage of Participants With ICH (Intracranial Hemorrhage) With Neurological Deterioration (NIHSS Worsening >4). | ICH with neurological deterioration (NIHSS worsening >4) will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected. | One patient had no NIHSS scores after baseline and was excluded from this analysis | Posted | | Number | | percentage of participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Best Medical Therapy | Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:
- General medical management according to AHA/ASA guidelines
- Admission to monitored or intensive care unit for at least 24 hours
- Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient
- Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician
- Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines
- Follow-up imaging study required in any patient with neurologic deterioration
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| Secondary | Percentage of Participants With SAE's Related to a Thrombectomy Procedure | A Thrombectomy is an interventional procedure to remove a blood clot (thrombus) from a blood vessel in the brain. Procedure related SAE's will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected. | | Posted | | Number | | Percentage of participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Best Medical Therapy | Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:
- General medical management according to AHA/ASA guidelines
- Admission to monitored or intensive care unit for at least 24 hours
- Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient
- Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician
- Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines
- Follow-up imaging study required in any patient with neurologic deterioration
| | OG001 | Endovascular Treatment |
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| Secondary | Arterial Revascularization Measured by TICI 2b or 3 Following Device Use | Arterial revascularization measured by TICI 2b or 3 following device use will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected. | | Posted | | Number | | percentage of participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Best Medical Therapy | Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:
- General medical management according to AHA/ASA guidelines
- Admission to monitored or intensive care unit for at least 24 hours
- Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient
- Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician
- Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines
- Follow-up imaging study required in any patient with neurologic deterioration
| | OG001 | Endovascular Treatment |
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| Secondary | Percentage of Patients With Serious Adverse Events (SAEs) Related to Thrombectomy Device. | A Thrombectomy device is a device intended to restore blood flow in a vessel in the brain by removing a blood clot (thrombus). | | Posted | | Number | | percentage of participants | | 90 days | | | | ID | Title | Description |
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| OG000 | Best Medical Therapy | Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. Standardization of medical management in both arms will occur according to the following:
- General medical management according to AHA/ASA guidelines
- Admission to monitored or intensive care unit for at least 24 hours
- Aggressive hypertensive-hypervolemic therapy should be used only in the case of symptomatic blood pressure fluctuations or if blood pressure drops below the normal range for the patient
- Antithrombotics: ASA 325 mg PO qd for 7 days (clopidogrel may be used as adjunctive therapy if indicated for cardiac disease) then per discretion of treating physician
- Close monitoring of BP and glucose with treatment according to AHA/ASA guidelines
- Follow-up imaging study required in any patient with neurologic deterioration
| | OG001 | Endovascular Treatment | Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination. |
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