Trial Outcomes & Findings for POSITIVE Stroke Clinical Trial (NCT NCT01852201)

NCT ID: NCT01852201

Last Updated: 2019-11-13

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2019-11-13

Participant Flow

Participant milestones

Measure	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	Endovascular Treatment (Thrombectomy Procedure 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 r
Overall Study STARTED	21	12
Overall Study COMPLETED	21	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

POSITIVE Stroke Clinical Trial

Baseline characteristics by cohort

Measure	Best Medical Therapy n=21 Participants 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	Endovascular Treatment n=12 Participants 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 r	Total n=33 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 13 • n=5 Participants	70 years STANDARD_DEVIATION 10.1 • n=7 Participants	67 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	12 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	12 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

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.

Outcome measures

Measure	Best Medical Therapy n=21 Participants 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	Endovascular Treatment n=12 Participants 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
Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS)	42.9 percentage of participants	75 percentage of participants

SECONDARY outcome

Timeframe: 90 day

Population: There were only 12 participants total in the 6-12hr cohort

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.

Outcome measures

Measure	Best Medical Therapy n=8 Participants 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	Endovascular Treatment n=4 Participants 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
Percentage of Participants in the 6-12 hr Cohort With Global Disability as Assessed by the Modified Rankin Score (mRS)	62.5 percentage of participants	50 percentage of participants

SECONDARY outcome

Timeframe: 90 days

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.

Outcome measures

Measure	Best Medical Therapy n=21 Participants 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	Endovascular Treatment n=12 Participants 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
Percentage of Participants in the 6-12hr Cohort With Good Functional Recovery as Assessed by the Modified Rankin Scale (mRS)	42.9 Percentage of particpants	75.0 Percentage of particpants

SECONDARY outcome

Timeframe: 30 days

Population: The values for 4 subjects was not captured at this timepoint

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.

Outcome measures

Measure	Best Medical Therapy n=17 Participants 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	Endovascular Treatment n=12 Participants 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
Percentage of Participants Mortality at 30 Days	12 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Best Medical Therapy n=21 Participants 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	Endovascular Treatment n=12 Participants 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
Percentage of Participants Mortality at 90 Days	19.1 percentage of participants	8.3 percentage of participants

SECONDARY outcome

Timeframe: 90 days

Population: One patient had no NIHSS scores after baseline and was excluded from this analysis

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.

Outcome measures

Measure	Best Medical Therapy n=20 Participants 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	Endovascular Treatment n=12 Participants 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
Percentage of Participants With ICH (Intracranial Hemorrhage) With Neurological Deterioration (NIHSS Worsening >4).	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 90 days

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.

Outcome measures

Measure	Best Medical Therapy n=21 Participants 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	Endovascular Treatment n=12 Participants 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
Percentage of Participants With SAE's Related to a Thrombectomy Procedure	0.0 Percentage of participants	8.3 Percentage of participants

SECONDARY outcome

Timeframe: 90 days

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.

Outcome measures

Measure	Best Medical Therapy n=1 Participants 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	Endovascular Treatment n=12 Participants 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
Arterial Revascularization Measured by TICI 2b or 3 Following Device Use	100 percentage of participants	83 percentage of participants

SECONDARY outcome

Timeframe: 90 days

A Thrombectomy device is a device intended to restore blood flow in a vessel in the brain by removing a blood clot (thrombus).

Outcome measures

Measure	Best Medical Therapy n=21 Participants 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	Endovascular Treatment n=12 Participants 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
Percentage of Patients With Serious Adverse Events (SAEs) Related to Thrombectomy Device.	0 percentage of participants	0 percentage of participants

Adverse Events

Best Medical Therapy

Serious events: 12 serious events

Other events: 10 other events

Deaths: 4 deaths

Endovascular Treatment

Serious events: 4 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Measure	Best Medical Therapy n=21 participants at risk 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	Endovascular Treatment n=12 participants at risk 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 re
Vascular disorders Asymptomatic intracranial hemorrhage up to 24 hours post-randomization	9.5% 2/21 • Number of events 2 • Adverse event data was collected over the duration of the study-104 days	33.3% 4/12 • Number of events 4 • Adverse event data was collected over the duration of the study-104 days
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Respiratory, thoracic and mediastinal disorders Pneumonia	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Peripheal thromboembolic event	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Worsening of pre-exist. cond.- Severely reduced LV, mildly reduced RV systolic function	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Neurologic Deterioration	14.3% 3/21 • Number of events 4 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Emboli	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Cardiac disorders Myocardioal Infarction	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Cardiac disorders Congestive Heart Failure	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Infections and infestations Infected PICC Line	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Cardiac disorders Worsening of Pre Existing Condition-Mid Sternal Chest Pain	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Worsening of Pre Existing Condition-Diffuse encephalopathy and cortical irritability	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders dysphasia	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Worsening of Index Stroke	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Pneumothorax	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Gastrointestinal disorders Inability to Feed	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Musculoskeletal and connective tissue disorders L Hip dislocation requiring closed reduction	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Deep Vein Thrombosis	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Blood and lymphatic system disorders Troponinemia	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Skin and subcutaneous tissue disorders Cellulitis	4.8% 1/21 • Number of events 2 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Metabolic Encephalopathy	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
General disorders Altered Mental Status	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
General disorders Febrile with Chest Pain	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
General disorders Failure to thrive	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
General disorders Accidental narcotic overdose	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
Cardiac disorders Cardiac Arrest	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Pulmonary Embolism	4.8% 1/21 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days

Other adverse events

Measure	Best Medical Therapy n=21 participants at risk 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	Endovascular Treatment n=12 participants at risk 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 re
Vascular disorders Groin puncture site: hematoma	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
Cardiac disorders Arrythmia	9.5% 2/21 • Number of events 2 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Vasospasm	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
Gastrointestinal disorders Diarrhea	9.5% 2/21 • Number of events 2 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Distal Emboli	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	16.7% 2/12 • Number of events 2 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Neurological Deterioration (increase of >4 points on NIHSS)	14.3% 3/21 • Number of events 3 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Infections and infestations Bactermia	9.5% 2/21 • Number of events 2 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days
Blood and lymphatic system disorders Low Hemoglobin	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
Blood and lymphatic system disorders Anemia	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
Vascular disorders Hemorrhagic Conversion	0.00% 0/21 • Adverse event data was collected over the duration of the study-104 days	8.3% 1/12 • Number of events 1 • Adverse event data was collected over the duration of the study-104 days
General disorders Headache	9.5% 2/21 • Number of events 2 • Adverse event data was collected over the duration of the study-104 days	0.00% 0/12 • Adverse event data was collected over the duration of the study-104 days

Additional Information

Jonathan Lena, MD

Medical University of SC

Phone: 843-792-9226

Email: lena@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place