POSITIVE Stroke Clinical Trial

• ClinicalTrials.gov Identifier: NCT01852201
• Recruitment Status: Terminated
• First Posted: May 13, 2013
• Results First Posted: November 13, 2019
• Last Update Posted: November 13, 2019
• Sponsor: Medical University of South Carolina
• Collaborator: Vanderbilt University
• Information provided by (Responsible Party): Medical University of South Carolina

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ischemic Stroke
• Intervention: Device: Endovascular Mechanical Thrombectomy
• Enrollment: 33

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Medical Therapy	Endovascular Treatment (Thrombectomy Procedure
Arm/Group Description	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 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
Period Title: Overall Study
Started	21	12
Completed	21	12
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Best Medical Therapy	Endovascular Treatment	Total
Arm/Group Description		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 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 of all reporting groups
Overall Number of Baseline Participants		21	12	33
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	21 participants	12 participants	33 participants
		65 (13)	70 (10.1)	67 (12.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	12 participants	33 participants
	Female	8 38.1%	8 66.7%	16 48.5%
	Male	13 61.9%	4 33.3%	17 51.5%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	12 participants	33 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	21 100.0%	12 100.0%	33 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	21 participants	12 participants	33 participants
		21	12	33

Outcome Measures

1. Primary Outcome

Title	Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS)
Description	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.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Best Medical Therapy	Endovascular Treatment
Arm/Group Description:	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 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
Overall Number of Participants Analyzed	21	12
Measure Type: Number; Unit of Measure: percentage of participants
	42.9	75

2. Secondary Outcome

Title	Percentage of Participants in the 6-12 hr Cohort With Global Disability as Assessed by the Modified Rankin Score (mRS)
Description	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.
Time Frame	90 day

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Best Medical Therapy	Endovascular Treatment
Arm/Group Description:	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 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.
Overall Number of Participants Analyzed	8	4
Measure Type: Number; Unit of Measure: percentage of participants
	62.5	50

3. Secondary Outcome

Title	Percentage of Participants in the 6-12hr Cohort With Good Functional Recovery as Assessed by the Modified Rankin Scale (mRS)
Description	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.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Best Medical Therapy	Endovascular Treatment
Arm/Group Description:	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 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.
Overall Number of Participants Analyzed	21	12
Measure Type: Number; Unit of Measure: Percentage of particpants
	42.9	75.0

4. Secondary Outcome

Title	Percentage of Participants Mortality at 30 Days
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The values for 4 subjects was not captured at this timepoint

Arm/Group Title	Best Medical Therapy	Endovascular Treatment
Arm/Group Description:	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 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.
Overall Number of Participants Analyzed	17	12
Measure Type: Number; Unit of Measure: percentage of participants
	12	0

5. Secondary Outcome

Title	Percentage of Participants Mortality at 90 Days
Description	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.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Best Medical Therapy	Endovascular Treatment
Arm/Group Description:	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 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.
Overall Number of Participants Analyzed	21	12
Measure Type: Number; Unit of Measure: percentage of participants
	19.1	8.3

6. Secondary Outcome

Title	Percentage of Participants With ICH (Intracranial Hemorrhage) With Neurological Deterioration (NIHSS Worsening >4).
Description	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.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Best Medical Therapy	Endovascular Treatment
Arm/Group Description:	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 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.
Overall Number of Participants Analyzed	20	12
Measure Type: Number; Unit of Measure: percentage of participants
	0	0

7. Secondary Outcome

Title	Percentage of Participants With SAE's Related to a Thrombectomy Procedure
Description	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.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Best Medical Therapy	Endovascular Treatment
Arm/Group Description:	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 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.
Overall Number of Participants Analyzed	21	12
Measure Type: Number; Unit of Measure: Percentage of participants
	0.0	8.3

8. Secondary Outcome

Title	Arterial Revascularization Measured by TICI 2b or 3 Following Device Use
Description	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.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Best Medical Therapy	Endovascular Treatment
Arm/Group Description:	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 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.
Overall Number of Participants Analyzed	1	12
Measure Type: Number; Unit of Measure: percentage of participants
	100	83

9. Secondary Outcome

Title	Percentage of Patients With Serious Adverse Events (SAEs) Related to Thrombectomy Device.
Description	A Thrombectomy device is a device intended to restore blood flow in a vessel in the brain by removing a blood clot (thrombus).
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Best Medical Therapy	Endovascular Treatment
Arm/Group Description:	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 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.
Overall Number of Participants Analyzed	21	12
Measure Type: Number; Unit of Measure: percentage of participants
	0	0

Adverse Events

Time Frame	Adverse event data was collected over the duration of the study-104 days
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Best Medical Therapy		Endovascular Treatment
Arm/Group Description	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 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
All-Cause Mortality
	Best Medical Therapy		Endovascular Treatment
	Affected / at Risk (%)		Affected / at Risk (%)
Total	4/21 (19.05%)		1/12 (8.33%)
Serious Adverse Events
	Best Medical Therapy		Endovascular Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/21 (57.14%)		4/12 (33.33%)
Blood and lymphatic system disorders
Troponinemia †	1/21 (4.76%)	1	0/12 (0.00%)	0
Cardiac disorders
Myocardioal Infarction †	1/21 (4.76%)	1	0/12 (0.00%)	0
Congestive Heart Failure †	1/21 (4.76%)	1	0/12 (0.00%)	0
Worsening of Pre Existing Condition-Mid Sternal Chest Pain †	0/21 (0.00%)	0	1/12 (8.33%)	1
Cardiac Arrest †	0/21 (0.00%)	0	1/12 (8.33%)	1
Gastrointestinal disorders
Inability to Feed †	1/21 (4.76%)	1	0/12 (0.00%)	0
General disorders
Altered Mental Status †	1/21 (4.76%)	1	0/12 (0.00%)	0
Febrile with Chest Pain †	1/21 (4.76%)	1	0/12 (0.00%)	0
Failure to thrive †	1/21 (4.76%)	1	0/12 (0.00%)	0
Accidental narcotic overdose †	0/21 (0.00%)	0	1/12 (8.33%)	1
Infections and infestations
Infected PICC Line *	1/21 (4.76%)	1	0/12 (0.00%)	0
Musculoskeletal and connective tissue disorders
L Hip dislocation requiring closed reduction †	0/21 (0.00%)	0	1/12 (8.33%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure †	1/21 (4.76%)	1	0/12 (0.00%)	0
Pneumonia †	1/21 (4.76%)	1	0/12 (0.00%)	0
Skin and subcutaneous tissue disorders
Cellulitis †	1/21 (4.76%)	2	0/12 (0.00%)	0
Vascular disorders
Asymptomatic intracranial hemorrhage up to 24 hours post-randomization †	2/21 (9.52%)	2	4/12 (33.33%)	4
Peripheal thromboembolic event †	0/21 (0.00%)	0	1/12 (8.33%)	1
Worsening of pre-exist. cond.- Severely reduced LV, mildly reduced RV systolic function †	1/21 (4.76%)	1	0/12 (0.00%)	0
Neurologic Deterioration †	3/21 (14.29%)	4	0/12 (0.00%)	0
Emboli †	1/21 (4.76%)	1	0/12 (0.00%)	0
Worsening of Pre Existing Condition-Diffuse encephalopathy and cortical irritability †	1/21 (4.76%)	1	0/12 (0.00%)	0
dysphasia †	1/21 (4.76%)	1	0/12 (0.00%)	0
Worsening of Index Stroke †	1/21 (4.76%)	1	0/12 (0.00%)	0
Pneumothorax †	1/21 (4.76%)	1	0/12 (0.00%)	0
Deep Vein Thrombosis †	1/21 (4.76%)	1	0/12 (0.00%)	0
Metabolic Encephalopathy †	1/21 (4.76%)	1	0/12 (0.00%)	0
Pulmonary Embolism †	1/21 (4.76%)	1	0/12 (0.00%)	0
† Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Best Medical Therapy		Endovascular Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/21 (47.62%)		9/12 (75.00%)
Blood and lymphatic system disorders
Low Hemoglobin †	0/21 (0.00%)	0	1/12 (8.33%)	1
Anemia †	0/21 (0.00%)	0	1/12 (8.33%)	1
Cardiac disorders
Arrythmia †	2/21 (9.52%)	2	1/12 (8.33%)	1
Gastrointestinal disorders
Diarrhea *	2/21 (9.52%)	2	0/12 (0.00%)	0
General disorders
Headache †	2/21 (9.52%)	2	0/12 (0.00%)	0
Infections and infestations
Bactermia †	2/21 (9.52%)	2	0/12 (0.00%)	0
Skin and subcutaneous tissue disorders
Cellulitis †	0/21 (0.00%)	0	1/12 (8.33%)	1
Vascular disorders
Groin puncture site: hematoma †	0/21 (0.00%)	0	1/12 (8.33%)	1
Vasospasm †	0/21 (0.00%)	0	1/12 (8.33%)	1
Distal Emboli †	0/21 (0.00%)	0	2/12 (16.67%)	2
Neurological Deterioration (increase of >4 points on NIHSS) †	3/21 (14.29%)	3	0/12 (0.00%)	0
Hemorrhagic Conversion †	0/21 (0.00%)	0	1/12 (8.33%)	1
† Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Jonathan Lena, MD
• Organization: Medical University of SC
• Phone: 843-792-9226
• EMail: lena@musc.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.

Mocco J, Siddiqui AH, Fiorella D, Alexander MJ, Arthur AS, Baxter BW, Budzik RF, Froehler MT, Hanel RA, Lena J, Persaud S, Puri AS, Rai AT, Wintermark M, Woodward K, Zhang X, Turk A. POSITIVE: Perfusion imaging selection of ischemic stroke patients for endovascular therapy. J Neurointerv Surg. 2022 Feb;14(2):126-132. doi: 10.1136/neurintsurg-2021-017315. Epub 2021 Feb 25.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01852201
• Other Study ID Numbers: PRO23329
• First Submitted: April 23, 2013
• First Posted: May 13, 2013
• Results First Submitted: October 22, 2019
• Results First Posted: November 13, 2019
• Last Update Posted: November 13, 2019