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Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3 (DEFUSE 3)

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: NCT02586415
Recruitment Status : Terminated (Interim analysis showed a high likelihood of benefit in the endovascular group)
First Posted : October 26, 2015
Results First Posted : September 19, 2018
Last Update Posted : May 21, 2019
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati
Medical University of South Carolina
NINDS Stroke Trials Network (StrokeNet)
Information provided by (Responsible Party):
Gregory W Albers, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stroke, Acute
Cerebral Infarction
Interventions Procedure: Endovascular Thrombectomy
Device: Trevo Retriever
Device: Solitaire™ FR Revascularization Device
Device: Penumbra thrombectomy system
Device: Covidien MindFrame Capture Revascularization Device
Enrollment 182
Recruitment Details From May 2016 through May 2017, a total of 182 patients underwent randomization (92 to the endovascular-therapy group and 90 to the medical-therapy group) at 38 centers in the United States.
Pre-assignment Details After obtaining written informed consent, participants were randomized if they met all clinical and imaging eligibility requirements and could undergo initiation of endovascular therapy between 6 and 16 hours after the time that they had last been known to be well.
Arm/Group Title Endovascular Thrombectomy Therapy Medical Management
Hide Arm/Group Description

Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.

Devices approved for use in DEFUSE 3:

  • Trevo Retriever
  • Solitaire™ FR Revascularization Device
  • Penumbra thrombectomy system
  • Covidien MindFrame Capture Revascularization Device

Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.

Trevo Retriever: Trevo R

standard medical therapy alone
Period Title: Overall Study
Started 92 90
24 Hour Assessment 91 90
Day 30 Assessment 81 70
Day 90 Assessment 78 65
Completed 78 65
Not Completed 14 25
Reason Not Completed
Death             13             23
Lost to Follow-up             1             2
Arm/Group Title Endovascular Thrombectomy Therapy Medical Management Total
Hide Arm/Group Description

Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.

Devices approved for use in DEFUSE 3:

  • Trevo Retriever
  • Solitaire™ FR Revascularization Device
  • Penumbra thrombectomy system
  • Covidien MindFrame Capture Revascularization Device

Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.

standard medical therapy alone Total of all reporting groups
Overall Number of Baseline Participants 92 90 182
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 92 participants 90 participants 182 participants
70
(59 to 78.5)
71
(59 to 80)
70.5
(59 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 90 participants 182 participants
Female
46
  50.0%
46
  51.1%
92
  50.5%
Male
46
  50.0%
44
  48.9%
90
  49.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 90 participants 182 participants
Hispanic or Latino
14
  15.2%
10
  11.1%
24
  13.2%
Not Hispanic or Latino
77
  83.7%
80
  88.9%
157
  86.3%
Unknown or Not Reported
1
   1.1%
0
   0.0%
1
   0.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 90 participants 182 participants
American Indian or Alaska Native
0
   0.0%
1
   1.1%
1
   0.5%
Asian
3
   3.3%
3
   3.3%
6
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  10.9%
5
   5.6%
15
   8.2%
White
78
  84.8%
80
  88.9%
158
  86.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.1%
1
   1.1%
2
   1.1%
NIHSS, continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 92 participants 90 participants 182 participants
16
(10 to 20)
16
(12 to 21)
16
(11 to 21)
[1]
Measure Description: The NIHSS is a clinician-rated, 15-item scale designed to assess the severity of stroke-related neurological deficits: level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect. Each item is rated on a 3-, 4-, or 5-point scale ranging from 0 (normal) to the maximum score (extremely severe symptoms). The total score of the 15 items ranges from 0 to 42, where lower scores indicate less impairment.
1.Primary Outcome
Title The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90
Hide Description

The modified Rankin Scale (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. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Endovascular Thrombectomy Therapy Medical Management
Hide Arm/Group Description:

Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.

Devices approved for use in DEFUSE 3:

  • Trevo Retriever
  • Solitaire™ FR Revascularization Device
  • Penumbra thrombectomy system
  • Covidien MindFrame Capture Revascularization Device

Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.

standard medical therapy alone
Overall Number of Participants Analyzed 92 90
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
3
(1 to 4)
4
(3 to 6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Endovascular Thrombectomy Therapy, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Criteria to assess superiority was a two-sided P value of <0.05. The study was terminated early because the pre-specified stopping boundary of P <0.0025 was crossed at the first interim analysis (N=182)
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.77
Confidence Interval (2-Sided) 95%
1.63 to 4.70
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Count of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence
Hide Description

The modified Rankin Scale (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. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms.

  • No significant disability. Able to carry out all usual activities, despite some symptoms.
  • Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  • Moderate disability. Requires some help, but able to walk unassisted.
  • Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  • Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  • Dead.
Time Frame day 90
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Endovascular Thrombectomy Therapy Medical Management
Hide Arm/Group Description:

Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.

Devices approved for use in DEFUSE 3:

  • Trevo Retriever
  • Solitaire™ FR Revascularization Device
  • Penumbra thrombectomy system
  • Covidien MindFrame Capture Revascularization Device

Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.

standard medical therapy alone
Overall Number of Participants Analyzed 92 90
Measure Type: Count of Participants
Unit of Measure: Participants
41
  44.6%
15
  16.7%
3.Other Pre-specified Outcome
Title Count of Participants With Symptomatic Intracranial Hemorrhage (Primary Safety Outcome)
Hide Description Defined as NIHSS worsening of 4 or more points associated with brain hemorrhage within 36 hours of randomization
Time Frame 36 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Therapy Medical Management
Hide Arm/Group Description:
Treatment with one or more thrombectomy devices cleared by the FDA for thrombus removal in patients experiencing an acute stroke.
standard medical therapy alone
Overall Number of Participants Analyzed 92 90
Measure Type: Count of Participants
Unit of Measure: Participants
6
   6.5%
4
   4.4%
4.Other Pre-specified Outcome
Title Parenchymal Hematoma Type 2 (Safety Outcome)
Hide Description PH 2 rates on the 24 hour scan (±6)
Time Frame 24 (±6) hours
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Infarct Volume (Imaging Outcome)
Hide Description Infarct volume on diffusion-weighted MRI (or CT if MRI not feasible) at 24 (±6) hours after randomization
Time Frame 24 (+/- 6) hours
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Lesion Growth (Imaging Outcome)
Hide Description Lesion growth between the RAPID-identified ischemic core on baseline imaging and the infarct volume at 24 hours (±6)
Time Frame 24 hours (±6)
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Reperfusion (Imaging Outcome)
Hide Description Successful reperfusion defined as a >90% reduction in Tmax>6sec lesion volume between baseline and 24 hours
Time Frame between baseline and 24 hours (+/- 6 hours)
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Recanalization (Imaging Outcome)
Hide Description Recanalization of the primary arterial occlusive lesion at 24-hours on CTA/MRA
Time Frame 24 hours (±6)
Outcome Measure Data Not Reported
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Endovascular Thrombectomy Therapy Medical Management
Hide Arm/Group Description

Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.

Devices approved for use in DEFUSE 3:

  • Trevo Retriever
  • Solitaire™ FR Revascularization Device
  • Penumbra thrombectomy system
  • Covidien MindFrame Capture Revascularization Device

Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.

standard medical therapy alone
All-Cause Mortality
Endovascular Thrombectomy Therapy Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   13/92 (14.13%)      23/90 (25.56%)    
Hide Serious Adverse Events
Endovascular Thrombectomy Therapy Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/92 (43.48%)      48/90 (53.33%)    
Cardiac disorders     
Atrial fibrillation  1  1/92 (1.09%)  1 2/90 (2.22%)  2
Cardiac arrest  1  1/92 (1.09%)  1 2/90 (2.22%)  2
Cardio-respiratory arrest  1  2/92 (2.17%)  2 1/90 (1.11%)  1
Cardiopulmonary failure  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Gastrointestinal disorders     
Chronic gastrointestinal bleeding  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Constipation  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Gastrointestinal haemorrhage  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Large intestine perforation  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Lower gastrointestinal haemorrhage  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Pancreatitis acute  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Pneumoperitoneum  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Retroperitoneal haematoma  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Upper gastrointestinal haemorrhage  1  1/92 (1.09%)  1 1/90 (1.11%)  1
General disorders     
Asthenia  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Chest pain  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Death  1  1/92 (1.09%)  1 1/90 (1.11%)  1
Infections and infestations     
Pneumonia klebsiella  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Pneumonia  1  1/92 (1.09%)  1 1/90 (1.11%)  1
Sepsis  1  1/92 (1.09%)  1 4/90 (4.44%)  4
Septic shock  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Urosepsis  1  1/92 (1.09%)  1 1/90 (1.11%)  1
Wound infection  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Feeding tube complication  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder neoplasm  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Nervous system disorders     
Aphasia  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Brain oedema  1  4/92 (4.35%)  4 3/90 (3.33%)  3
Carotid artery dissection  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Cerebellar haemorrhage  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Cerebral haemorrhage  1  1/92 (1.09%)  1 2/90 (2.22%)  2
Cerebral infarction  1  2/92 (2.17%)  2 1/90 (1.11%)  1
Cerebrovascular accident  1  2/92 (2.17%)  2 5/90 (5.56%)  5
Encephalopathy  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Haemorrhage intracranial  1  2/92 (2.17%)  2 2/90 (2.22%)  2
Haemorrhagic transformation stroke  1  3/92 (3.26%)  3 3/90 (3.33%)  3
Ischaemic stroke  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Metabolic encephalopathy  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Neurological decompensation  1  2/92 (2.17%)  2 3/90 (3.33%)  3
Seizure  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Somnolence  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Stroke in evolution  1  3/92 (3.26%)  3 9/90 (10.00%)  9
Subarachnoid haemorrhage  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Syncope  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Product Issues     
Device occlusion  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Psychiatric disorders     
Depression  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Chronic kidney disease  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/92 (1.09%)  1 2/90 (2.22%)  2
Atelectasis  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Pneumonia aspiration  1  3/92 (3.26%)  3 5/90 (5.56%)  5
Pneumothorax  1  0/92 (0.00%)  0 2/90 (2.22%)  2
Pulmonary embolism  1  1/92 (1.09%)  1 3/90 (3.33%)  3
Respiratory arrest  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Respiratory failure  1  1/92 (1.09%)  1 2/90 (2.22%)  2
Vascular disorders     
Embolism  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Haematoma  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Hypotension  1  2/92 (2.17%)  2 1/90 (1.11%)  1
Hypovolaemic shock  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Thrombosis  1  0/92 (0.00%)  0 1/90 (1.11%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Endovascular Thrombectomy Therapy Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   57/92 (61.96%)      59/90 (65.56%)    
Blood and lymphatic system disorders     
Anaemia  1  3/92 (3.26%)  3 4/90 (4.44%)  4
Leukocytosis  1  1/92 (1.09%)  1 3/90 (3.33%)  3
Cardiac disorders     
Atrial fibrillation  1  6/92 (6.52%)  6 5/90 (5.56%)  5
Atrial flutter  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Atrioventricular block first degree  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Atrioventricular block second degree  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Bradyarrhythmia  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Bradycardia  1  1/92 (1.09%)  1 1/90 (1.11%)  1
Cardiac failure chronic  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Cardiac failure congestive  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Cardiac ventricular thrombosis  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Extrasystoles  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Left ventricular dysfunction  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Sinus bradycardia  1  2/92 (2.17%)  2 2/90 (2.22%)  2
Tachycardia  1  1/92 (1.09%)  1 2/90 (2.22%)  2
Ventricular tachycardia  1  2/92 (2.17%)  2 0/90 (0.00%)  0
Congenital, familial and genetic disorders     
Atrial septal defect  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Eye disorders     
Visual acuity reduced  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Gastrointestinal disorders     
Abdominal pain upper  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Aphthous ulcer  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Bowel movement irregularity  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Diarrhoea  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Dysphagia  1  3/92 (3.26%)  3 4/90 (4.44%)  4
Nausea  1  3/92 (3.26%)  3 1/90 (1.11%)  1
Vomiting  1  3/92 (3.26%)  3 0/90 (0.00%)  0
General disorders     
Chills  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Drug withdrawal syndrome  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Infusion site extravasation  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Oedema peripheral  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Pain  1  0/92 (0.00%)  0 2/90 (2.22%)  2
Pyrexia  1  7/92 (7.61%)  7 4/90 (4.44%)  4
Tenderness  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Infections and infestations     
Bacteraemia  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Bacterial disease carrier  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Bronchitis  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Cellulitis  1  1/92 (1.09%)  1 1/90 (1.11%)  1
Clostridium difficile colitis  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Clostridium difficile infection  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Conjunctivitis  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Fungal infection  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Pneumonia  1  1/92 (1.09%)  1 3/90 (3.33%)  3
Urinary tract infection bacterial  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Urinary tract infection  1  4/92 (4.35%)  4 10/90 (11.11%)  10
Injury, poisoning and procedural complications     
Fall  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Incision site pain  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Laceration  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Rib fracture  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Vascular pseudoaneurysm  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Investigations     
Blood creatinine increased  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Blood glucose increased  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Ejection fraction decreased  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Transaminases increased  1  1/92 (1.09%)  1 1/90 (1.11%)  1
Troponin increased  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Troponin  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/92 (1.09%)  1 2/90 (2.22%)  2
Gout  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Hyperglycaemia  1  1/92 (1.09%)  1 4/90 (4.44%)  4
Hyperlipidaemia  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Hypernatraemia  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Hypoglycaemia  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Hypokalaemia  1  3/92 (3.26%)  3 5/90 (5.56%)  5
Hyponatraemia  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Hypophosphataemia  1  1/92 (1.09%)  1 2/90 (2.22%)  2
Malnutrition  1  0/92 (0.00%)  0 2/90 (2.22%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Back pain  1  1/92 (1.09%)  1 3/90 (3.33%)  3
Musculoskeletal pain  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Neck pain  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Osteoarthritis  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Pain in extremity  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Pain in jaw  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Nervous system disorders     
Brain oedema  1  1/92 (1.09%)  2 0/90 (0.00%)  0
Cerebellar haemorrhage  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Cerebellar infarction  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Cerebral haemorrhage  1  4/92 (4.35%)  4 4/90 (4.44%)  4
Cerebral infarction  1  0/92 (0.00%)  0 3/90 (3.33%)  3
Haemorrhage intracranial  1  5/92 (5.43%)  5 1/90 (1.11%)  1
Haemorrhagic transformation stroke  1  15/92 (16.30%)  16 10/90 (11.11%)  10
Headache  1  5/92 (5.43%)  5 4/90 (4.44%)  4
Intracranial aneurysm  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Neurological decompensation  1  0/92 (0.00%)  0 5/90 (5.56%)  5
Neuropathy peripheral  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Restless legs syndrome  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Seizure  1  2/92 (2.17%)  2 2/90 (2.22%)  2
Sinus headache  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Spinal cord oedema  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Stroke in evolution  1  1/92 (1.09%)  1 3/90 (3.33%)  3
Psychiatric disorders     
Agitation  1  0/92 (0.00%)  0 3/90 (3.33%)  3
Alcohol withdrawal syndrome  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Anxiety  1  2/92 (2.17%)  2 0/90 (0.00%)  0
Depression  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Insomnia  1  1/92 (1.09%)  1 1/90 (1.11%)  1
Renal and urinary disorders     
Acute kidney injury  1  2/92 (2.17%)  2 1/90 (1.11%)  1
Urinary incontinence  1  0/92 (0.00%)  0 2/90 (2.22%)  2
Urinary retention  1  3/92 (3.26%)  3 2/90 (2.22%)  2
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Atelectasis  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Chronic obstructive pulmonary disease  1  1/92 (1.09%)  1 1/90 (1.11%)  1
Cough  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Dyspnoea  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Epistaxis  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Hypoxia  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Laryngeal oedema  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Pleural effusion  1  1/92 (1.09%)  1 1/90 (1.11%)  1
Pneumonia aspiration  1  4/92 (4.35%)  4 5/90 (5.56%)  5
Pulmonary oedema  1  3/92 (3.26%)  3 0/90 (0.00%)  0
Respiratory distress  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Tachypnoea  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Upper respiratory tract congestion  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Skin and subcutaneous tissue disorders     
Rash  1  3/92 (3.26%)  3 0/90 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  2/92 (2.17%)  2 3/90 (3.33%)  3
Haematoma  1  3/92 (3.26%)  3 0/90 (0.00%)  0
Hypertension  1  4/92 (4.35%)  4 4/90 (4.44%)  4
Hypotension  1  5/92 (5.43%)  5 5/90 (5.56%)  5
Thrombophlebitis superficial  1  0/92 (0.00%)  0 1/90 (1.11%)  1
Thrombosis  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Vasospasm  1  1/92 (1.09%)  1 0/90 (0.00%)  0
Vessel perforation  1  1/92 (1.09%)  1 0/90 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gregory Albers
Organization: Stanford University/School of Medicine
Phone: 650-723-4448
EMail: albers@stanford.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gregory W Albers, Stanford University
ClinicalTrials.gov Identifier: NCT02586415    
Other Study ID Numbers: 116661
U10NS086487 ( U.S. NIH Grant/Contract )
U01NS092076 ( U.S. NIH Grant/Contract )
First Submitted: October 21, 2015
First Posted: October 26, 2015
Results First Submitted: August 23, 2018
Results First Posted: September 19, 2018
Last Update Posted: May 21, 2019