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POSITIVE Stroke Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Medical Therapy Endovascular Treatment (Thrombectomy Procedure
Hide 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
Arm/Group Title Best Medical Therapy Endovascular Treatment Total
Hide 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
Hide 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
1.Primary Outcome
Title Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Best Medical Therapy Endovascular Treatment
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
There were only 12 participants total in the 6-12hr cohort
Arm/Group Title Best Medical Therapy Endovascular Treatment
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Best Medical Therapy Endovascular Treatment
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The values for 4 subjects was not captured at this timepoint
Arm/Group Title Best Medical Therapy Endovascular Treatment
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Best Medical Therapy Endovascular Treatment
Hide 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).
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Best Medical Therapy Endovascular Treatment
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Best Medical Therapy Endovascular Treatment
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Best Medical Therapy Endovascular Treatment
Hide 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
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
Hide 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%)    
Hide 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
Hide 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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jonathan Lena, MD
Organization: Medical University of SC
Phone: 843-792-9226
EMail: lena@musc.edu
Layout table for additonal information
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