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Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo (DAWN)

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: NCT02142283
Recruitment Status : Completed
First Posted : May 20, 2014
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Ischemic Stroke
Interventions Device: Trevo Thrombectomy Procedure
Other: Medical Management
Enrollment 206
Recruitment Details See protocol
Pre-assignment Details See protocol
Arm/Group Title Trevo Thrombectomy Procedure Medical Management
Hide Arm/Group Description

Trevo Thrombectomy Procedure and Medical Management

Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Medical Management

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Period Title: Overall Study
Started 107 99
Completed 86 78
Not Completed 21 21
Reason Not Completed
Death             20             18
Withdrawal by Subject             1             3
Arm/Group Title Trevo Thrombectomy Procedure Medical Management Total
Hide Arm/Group Description

Trevo Thrombectomy Procedure and Medical Management

Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Medical Management

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Total of all reporting groups
Overall Number of Baseline Participants 107 99 206
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ITT
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 99 participants 206 participants
69.4  (14.1) 70.7  (13.2) 70.0  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 99 participants 206 participants
Female
65
  60.7%
48
  48.5%
113
  54.9%
Male
42
  39.3%
51
  51.5%
93
  45.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 99 participants 206 participants
Hispanic or Latino
11
  10.3%
16
  16.2%
27
  13.1%
Not Hispanic or Latino
94
  87.9%
82
  82.8%
176
  85.4%
Unknown or Not Reported
2
   1.9%
1
   1.0%
3
   1.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 99 participants 206 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.9%
5
   5.1%
6
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.0%
1
   0.5%
Black or African American
23
  21.5%
15
  15.2%
38
  18.4%
White
70
  65.4%
63
  63.6%
133
  64.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
13
  12.1%
15
  15.2%
28
  13.6%
1.Primary Outcome
Title Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome
Hide Description

mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.

Functional Independence:

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
  3. - moderate disability; requiring some help, but able to walk without assistance
  4. - moderately 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
  6. - dead
Time Frame 90 days
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ITT
Arm/Group Title Trevo Thrombectomy Procedure Medical Management
Hide Arm/Group Description:

Trevo Thrombectomy Procedure and Medical Management

Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Medical Management

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Overall Number of Participants Analyzed 107 99
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.5  (3.8) 3.4  (3.2)
2.Primary Outcome
Title Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome
Hide Description

Number of participants with functional independence

mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.

Functional Independence:

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
ITT
Arm/Group Title Trevo Thrombectomy Procedure Medical Management
Hide Arm/Group Description:

Trevo Thrombectomy Procedure and Medical Management

Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Medical Management

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Overall Number of Participants Analyzed 107 99
Measure Type: Count of Participants
Unit of Measure: Participants
52
  48.6%
13
  13.1%
3.Primary Outcome
Title Stroke-related Mortality, Primary Safety Outcome
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
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ITT
Arm/Group Title Trevo Thrombectomy Procedure Medical Management
Hide Arm/Group Description:

Trevo Thrombectomy Procedure and Medical Management

Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Medical Management

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Overall Number of Participants Analyzed 107 99
Measure Type: Count of Participants
Unit of Measure: Participants
17
  15.9%
18
  18.2%
4.Secondary Outcome
Title Good Functional Outcome
Hide Description

Proportion of participants with functional independence

mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.

Functional Independence:

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
ITT
Arm/Group Title Trevo Thrombectomy Procedure Medical Management
Hide Arm/Group Description:

Trevo Thrombectomy Procedure and Medical Management

Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Medical Management

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Overall Number of Participants Analyzed 107 99
Measure Type: Count of Participants
Unit of Measure: Participants
52
  48.6%
13
  13.1%
5.Secondary Outcome
Title Early Response
Hide Description

The proportion of subjects with "early response" at Day 5-7/Discharge (whichever is earlier), defined as a National Institutes of Health Stroke Scale (NIHSS) drop of ≥10 from baseline or NIHSS score 0 or 1.

The NIHSS is an assessment which objectively quantifies the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

Time Frame 5-7 Days
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trevo Thrombectomy Procedure Medical Management
Hide Arm/Group Description:

Trevo Thrombectomy Procedure and Medical Management

Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Medical Management

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Overall Number of Participants Analyzed 107 99
Measure Type: Count of Participants
Unit of Measure: Participants
51
  47.7%
19
  19.2%
6.Secondary Outcome
Title All Cause Mortality
Hide Description [Not Specified]
Time Frame 90 days
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ITT
Arm/Group Title Trevo Thrombectomy Procedure Medical Management
Hide Arm/Group Description:

Trevo Thrombectomy Procedure and Medical Management

Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Medical Management

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Overall Number of Participants Analyzed 107 99
Measure Type: Count of Participants
Unit of Measure: Participants
20
  18.7%
18
  18.2%
7.Secondary Outcome
Title Revascularization Rates
Hide Description

Revascularization rates at 24 hours from randomization are based on the assessment of vessel patency utilizing CTA/MRA and processed by the CT-MR core laboratory. Revascularization at 24 hours was defined as the presence of partial or complete recanalization.

CTA/MRA images utilized ionizing radiation exposure.

Time Frame 24 hours
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ITT
Arm/Group Title Trevo Thrombectomy Procedure Medical Management
Hide Arm/Group Description:

Trevo Thrombectomy Procedure and Medical Management

Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Medical Management

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Overall Number of Participants Analyzed 107 99
Measure Type: Count of Participants
Unit of Measure: Participants
82
  76.6%
38
  38.4%
8.Secondary Outcome
Title Neurological Deterioration From Baseline NIHSS Score
Hide Description

Neurological deterioration from baseline NIHSS score through Day 5-7/discharge (whichever is earlier) post randomization. Neurological deterioration is defined as ≥ 4 point increase in the NIHSS score from the baseline score.

The calculated difference in NIHSS scores was assessed at baseline and Day 5-7/discharge (two time points).

The NIHSS is an assessment which objectively quantifies the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

Time Frame 5-7 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Trevo Thrombectomy Procedure Medical Management
Hide Arm/Group Description:

Trevo Thrombectomy Procedure and Medical Management

Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Medical Management

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Overall Number of Participants Analyzed 107 99
Measure Type: Count of Participants
Unit of Measure: Participants
15
  14.0%
26
  26.3%
Time Frame 90 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trevo Thrombectomy Procedure Medical Management
Hide Arm/Group Description

Trevo Thrombectomy Procedure and Medical Management

Trevo Thrombectomy Procedure: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

Medical Management

Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc

All-Cause Mortality
Trevo Thrombectomy Procedure Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   20/107 (18.69%)   18/99 (18.18%) 
Hide Serious Adverse Events
Trevo Thrombectomy Procedure Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   41/107 (38.32%)   47/99 (47.47%) 
Blood and lymphatic system disorders     
Chronic lymphocytic leukaemia   0/107 (0.00%)  1/99 (1.01%) 
Cardiac disorders     
Cardiac arrest   1/107 (0.93%)  1/99 (1.01%) 
Cardiac failure   1/107 (0.93%)  1/99 (1.01%) 
Cardiac failure congestive   1/107 (0.93%)  0/99 (0.00%) 
Cardio-respiratory arrest   1/107 (0.93%)  0/99 (0.00%) 
Chest pain   0/107 (0.00%)  1/99 (1.01%) 
Coronary artery stenosis   1/107 (0.93%)  0/99 (0.00%) 
Myocardial infarction   0/107 (0.00%)  1/99 (1.01%) 
Pulmonary oedema   2/107 (1.87%)  0/99 (0.00%) 
Ventricular extrasystoles   1/107 (0.93%)  0/99 (0.00%) 
Eye disorders     
Retinal artery occlusion   1/107 (0.93%)  0/99 (0.00%) 
Gastrointestinal disorders     
Acute abdomen   0/107 (0.00%)  1/99 (1.01%) 
Dysphagia   5/107 (4.67%)  9/99 (9.09%) 
Gastrointestinal haemorrhage   1/107 (0.93%)  0/99 (0.00%) 
Vomiting   1/107 (0.93%)  0/99 (0.00%) 
Immune system disorders     
Septic shock   0/107 (0.00%)  1/99 (1.01%) 
Infections and infestations     
Perineal abscess   0/107 (0.00%)  1/99 (1.01%) 
Pneumonia   6/107 (5.61%)  2/99 (2.02%) 
Pneumonia klebsiella   0/107 (0.00%)  1/99 (1.01%) 
Sepsis   0/107 (0.00%)  1/99 (1.01%) 
Urinary tract infection   0/107 (0.00%)  1/99 (1.01%) 
Injury, poisoning and procedural complications     
Fracture   0/107 (0.00%)  1/99 (1.01%) 
Subdural haematoma   1/107 (0.93%)  0/99 (0.00%) 
Vascular pseudoaneurysm   1/107 (0.93%)  0/99 (0.00%) 
Wound evisceration   0/107 (0.00%)  1/99 (1.01%) 
Musculoskeletal pain   0/107 (0.00%)  2/99 (2.02%) 
Nervous system disorders     
Aphasia   1/107 (0.93%)  0/99 (0.00%) 
Brain herniation   1/107 (0.93%)  0/99 (0.00%) 
Brain oedema   2/107 (1.87%)  5/99 (5.05%) 
Cerebral artery occlusion   0/107 (0.00%)  1/99 (1.01%) 
Cerebral infarction   1/107 (0.93%)  1/99 (1.01%) 
Cerebrovascular accident   3/107 (2.80%)  1/99 (1.01%) 
Convulsion   1/107 (0.93%)  0/99 (0.00%) 
Embolic stroke   1/107 (0.93%)  0/99 (0.00%) 
Haemorrhage intracranial   1/107 (0.93%)  1/99 (1.01%) 
Haemorrhagic transformation stroke   3/107 (2.80%)  1/99 (1.01%) 
Loss of consciousness   1/107 (0.93%)  0/99 (0.00%) 
Muscular weakness   0/107 (0.00%)  1/99 (1.01%) 
Neurological decompensation   0/107 (0.00%)  9/99 (9.09%) 
Status epilepticus   0/107 (0.00%)  1/99 (1.01%) 
Stroke in evolution   5/107 (4.67%)  9/99 (9.09%) 
Subarachnoid haemorrhage   1/107 (0.93%)  0/99 (0.00%) 
Carotid artery occlusion   0/107 (0.00%)  1/99 (1.01%) 
Cerebrovascular disorder   0/107 (0.00%)  1/99 (1.01%) 
Hypoaesthesia   0/107 (0.00%)  1/99 (1.01%) 
Psychiatric disorders     
Completed suicide   1/107 (0.93%)  0/99 (0.00%) 
Drug abuse   0/107 (0.00%)  1/99 (1.01%) 
Mental status changes   0/107 (0.00%)  1/99 (1.01%) 
Renal and urinary disorders     
Renal failure acute   0/107 (0.00%)  1/99 (1.01%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema   1/107 (0.93%)  0/99 (0.00%) 
Acute respiratory distress syndrome   2/107 (1.87%)  0/99 (0.00%) 
Acute respiratory failure   1/107 (0.93%)  3/99 (3.03%) 
Chronic obstructive pulmonary disease   1/107 (0.93%)  0/99 (0.00%) 
Haemothorax   1/107 (0.93%)  0/99 (0.00%) 
Pleural effusion   1/107 (0.93%)  0/99 (0.00%) 
Pneumonia aspiration   3/107 (2.80%)  2/99 (2.02%) 
Pulmonary embolism   0/107 (0.00%)  1/99 (1.01%) 
Respiratory distress   0/107 (0.00%)  2/99 (2.02%) 
Respiratory failure   3/107 (2.80%)  3/99 (3.03%) 
Tracheal oedema   1/107 (0.93%)  0/99 (0.00%) 
Surgical and medical procedures     
Amputation   1/107 (0.93%)  0/99 (0.00%) 
Cranioplasty   0/107 (0.00%)  1/99 (1.01%) 
Vascular disorders     
Deep vein thrombosis   1/107 (0.93%)  3/99 (3.03%) 
Hypotension   2/107 (1.87%)  1/99 (1.01%) 
Shock   1/107 (0.93%)  0/99 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trevo Thrombectomy Procedure Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   102/107 (95.33%)   91/99 (91.92%) 
Blood and lymphatic system disorders     
Anaemia   5/107 (4.67%)  3/99 (3.03%) 
Iron deficiency anemia   0/107 (0.00%)  1/99 (1.01%) 
Leukocytosis   5/107 (4.67%)  3/99 (3.03%) 
Thrombocytopenia   1/107 (0.93%)  0/99 (0.00%) 
Normochromic normocytic anaemia   0/107 (0.00%)  1/99 (1.01%) 
Cardiac disorders     
Aortic valve incompetence   1/107 (0.93%)  0/99 (0.00%) 
Arrhythmia   1/107 (0.93%)  0/99 (0.00%) 
Atrial fibrillation   14/107 (13.08%)  13/99 (13.13%) 
Bradycardia   2/107 (1.87%)  1/99 (1.01%) 
Cardiac failure   2/107 (1.87%)  2/99 (2.02%) 
Cardiac failure congestive   1/107 (0.93%)  0/99 (0.00%) 
Cardiomegaly   1/107 (0.93%)  0/99 (0.00%) 
Intracardiac thrombus   1/107 (0.93%)  0/99 (0.00%) 
Left ventricular failure   1/107 (0.93%)  0/99 (0.00%) 
Myocardial infarction   0/107 (0.00%)  2/99 (2.02%) 
Pulmonary oedema   3/107 (2.80%)  2/99 (2.02%) 
Sinus bradycardia   0/107 (0.00%)  1/99 (1.01%) 
Tachycardia   2/107 (1.87%)  2/99 (2.02%) 
Ventricular extrasystoles   1/107 (0.93%)  0/99 (0.00%) 
Ventricular tachycardia   1/107 (0.93%)  4/99 (4.04%) 
Artial flutter   2/107 (1.87%)  1/99 (1.01%) 
Artial tachycardia   0/107 (0.00%)  1/99 (1.01%) 
Sick sinus syndrome   1/107 (0.93%)  0/99 (0.00%) 
Supraventricular tachycardia   1/107 (0.93%)  0/99 (0.00%) 
Endocrine disorders     
Hypothyroidism   1/107 (0.93%)  0/99 (0.00%) 
Eye disorders     
Cataract   0/107 (0.00%)  1/99 (1.01%) 
Dry eye   0/107 (0.00%)  1/99 (1.01%) 
Gastrointestinal disorders     
Abdominal discomfort   0/107 (0.00%)  2/99 (2.02%) 
Abdominal distention   0/107 (0.00%)  1/99 (1.01%) 
Abdominal pain   1/107 (0.93%)  0/99 (0.00%) 
Abdominal pain upper   1/107 (0.93%)  0/99 (0.00%) 
Clostridium difficile colitis   0/107 (0.00%)  2/99 (2.02%) 
Constipation   10/107 (9.35%)  3/99 (3.03%) 
Dental caries   1/107 (0.93%)  0/99 (0.00%) 
Diarrhoea   4/107 (3.74%)  3/99 (3.03%) 
Dyspepsia   1/107 (0.93%)  0/99 (0.00%) 
Dysphagia   7/107 (6.54%)  13/99 (13.13%) 
Gastric hypomotility   1/107 (0.93%)  0/99 (0.00%) 
Gastrointestinal haemorrhage   0/107 (0.00%)  2/99 (2.02%) 
Haematochezia   1/107 (0.93%)  1/99 (1.01%) 
Hiatus hernia   0/107 (0.00%)  1/99 (1.01%) 
Hiccups   1/107 (0.93%)  0/99 (0.00%) 
Ileus   1/107 (0.93%)  0/99 (0.00%) 
Intussusception   0/107 (0.00%)  1/99 (1.01%) 
Nausea   8/107 (7.48%)  5/99 (5.05%) 
Small intestinal obstruction   0/107 (0.00%)  1/99 (1.01%) 
Vomiting   5/107 (4.67%)  3/99 (3.03%) 
General disorders     
Chest pain   1/107 (0.93%)  0/99 (0.00%) 
Device occulsion   1/107 (0.93%)  0/99 (0.00%) 
Fatigue   3/107 (2.80%)  1/99 (1.01%) 
Local swelling   0/107 (0.00%)  1/99 (1.01%) 
Oedema   1/107 (0.93%)  0/99 (0.00%) 
Oedema peripheral   2/107 (1.87%)  0/99 (0.00%) 
Pain   6/107 (5.61%)  8/99 (8.08%) 
Pyrexia   8/107 (7.48%)  5/99 (5.05%) 
Hepatobiliary disorders     
Cholelithiasis   0/107 (0.00%)  1/99 (1.01%) 
Immune system disorders     
Reaction to drug   0/107 (0.00%)  1/99 (1.01%) 
Infections and infestations     
Bronchitis   2/107 (1.87%)  0/99 (0.00%) 
Cellulitis   2/107 (1.87%)  0/99 (0.00%) 
Clostridium difficile infection   0/107 (0.00%)  1/99 (1.01%) 
Conjunctivitis   1/107 (0.93%)  1/99 (1.01%) 
Erysipelas   1/107 (0.93%)  0/99 (0.00%) 
Fungal infection   1/107 (0.93%)  3/99 (3.03%) 
Infection   0/107 (0.00%)  2/99 (2.02%) 
Influenza   0/107 (0.00%)  2/99 (2.02%) 
Mucosal infection   1/107 (0.93%)  0/99 (0.00%) 
Oral candidiasis   3/107 (2.80%)  3/99 (3.03%) 
Penumonia   6/107 (5.61%)  8/99 (8.08%) 
Purulent discharge   0/107 (0.00%)  1/99 (1.01%) 
Respiratory tract infection   0/107 (0.00%)  1/99 (1.01%) 
Sepsis   2/107 (1.87%)  2/99 (2.02%) 
Septic shock   2/107 (1.87%)  0/99 (0.00%) 
Sinusitis   1/107 (0.93%)  2/99 (2.02%) 
Skin candida   0/107 (0.00%)  1/99 (1.01%) 
Staphylococcal infection   1/107 (0.93%)  2/99 (2.02%) 
Urinary tract infection   22/107 (20.56%)  22/99 (22.22%) 
Urosepsis   1/107 (0.93%)  0/99 (0.00%) 
Vaginal infection   0/107 (0.00%)  1/99 (1.01%) 
Injury, poisoning and procedural complications     
Compression fracture   0/107 (0.00%)  1/99 (1.01%) 
Craniocerebral injury   1/107 (0.93%)  0/99 (0.00%) 
Fall   3/107 (2.80%)  3/99 (3.03%) 
Joint dislocation   1/107 (0.93%)  0/99 (0.00%) 
Nephropathy toxic   1/107 (0.93%)  0/99 (0.00%) 
Pseudomeningocele   0/107 (0.00%)  1/99 (1.01%) 
Skin wound   1/107 (0.93%)  0/99 (0.00%) 
Wound   0/107 (0.00%)  1/99 (1.01%) 
Wrist fracture   1/107 (0.93%)  0/99 (0.00%) 
Blood lactate dehydrogenase abnormal   1/107 (0.93%)  0/99 (0.00%) 
Blood lactic acid increased   0/107 (0.00%)  1/99 (1.01%) 
Cardiac enzymes increased   0/107 (0.00%)  1/99 (1.01%) 
Investigations     
Computerised tomogram abnormal   1/107 (0.93%)  0/99 (0.00%) 
Electroencephalogram abnormal   2/107 (1.87%)  0/99 (0.00%) 
International normalized ratio increased   0/107 (0.00%)  1/99 (1.01%) 
Investigation abnormal   0/107 (0.00%)  1/99 (1.01%) 
Liver function analyses   0/107 (0.00%)  1/99 (1.01%) 
Transaminases increased   0/107 (0.00%)  2/99 (2.02%) 
Troponin increased   1/107 (0.93%)  1/99 (1.01%) 
Weight decreased   0/107 (0.00%)  1/99 (1.01%) 
Electrocardiogram QT prolonged   0/107 (0.00%)  1/99 (1.01%) 
Metabolism and nutrition disorders     
Dehydration   1/107 (0.93%)  0/99 (0.00%) 
Diabetes mellitus   2/107 (1.87%)  1/99 (1.01%) 
Diabetes mellitus inadequate control   0/107 (0.00%)  1/99 (1.01%) 
Electrolyte imbalance   2/107 (1.87%)  0/99 (0.00%) 
Gout   1/107 (0.93%)  0/99 (0.00%) 
Hypercholesterolaemia   0/107 (0.00%)  1/99 (1.01%) 
Hypercreatinaemia   1/107 (0.93%)  0/99 (0.00%) 
Hypergylcaemia   7/107 (6.54%)  6/99 (6.06%) 
Hyperkalaemia   2/107 (1.87%)  1/99 (1.01%) 
Hyperlipidaemia   1/107 (0.93%)  0/99 (0.00%) 
Hypernatraemia   3/107 (2.80%)  6/99 (6.06%) 
Hypophosphataemia   7/107 (6.54%)  2/99 (2.02%) 
Hypovitaminosis   0/107 (0.00%)  1/99 (1.01%) 
Iron deficiency   0/107 (0.00%)  1/99 (1.01%) 
Malnutrition   0/107 (0.00%)  1/99 (1.01%) 
Metabolic acidosis   0/107 (0.00%)  1/99 (1.01%) 
Type 2 diabetes mellitus   0/107 (0.00%)  1/99 (1.01%) 
Vitamin B12 deficiency   2/107 (1.87%)  0/99 (0.00%) 
Vitamin D deficiency   1/107 (0.93%)  0/99 (0.00%) 
Monoarthritis   0/107 (0.00%)  1/99 (1.01%) 
Hypokalaemia   32/107 (29.91%)  20/99 (20.20%) 
Hypocalcaemia   1/107 (0.93%)  1/99 (1.01%) 
Hypoglycaemia   1/107 (0.93%)  4/99 (4.04%) 
Hypomagnesaemia   6/107 (5.61%)  7/99 (7.07%) 
Hyponatraemia   3/107 (2.80%)  0/99 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   1/107 (0.93%)  2/99 (2.02%) 
Back pain   2/107 (1.87%)  3/99 (3.03%) 
Bursitis   0/107 (0.00%)  1/99 (1.01%) 
Gouty arthritis   1/107 (0.93%)  0/99 (0.00%) 
Muscle spasms   0/107 (0.00%)  2/99 (2.02%) 
Musculoskeletal pain   1/107 (0.93%)  4/99 (4.04%) 
Neck pain   0/107 (0.00%)  1/99 (1.01%) 
Pain in extremity   5/107 (4.67%)  7/99 (7.07%) 
Spondylolisthesis   1/107 (0.93%)  0/99 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pancreatic cancer   1/107 (0.93%)  0/99 (0.00%) 
Nervous system disorders     
Allodynia   0/107 (0.00%)  1/99 (1.01%) 
Basal ganglia infarction   1/107 (0.93%)  0/99 (0.00%) 
Brain herniation   1/107 (0.93%)  0/99 (0.00%) 
Brain oedema   5/107 (4.67%)  7/99 (7.07%) 
Carotid artery stenosis   3/107 (2.80%)  1/99 (1.01%) 
Central pain syndrome   1/107 (0.93%)  0/99 (0.00%) 
Cerebral artery embolism   4/107 (3.74%)  0/99 (0.00%) 
Cerebral artery occlusion   1/107 (0.93%)  1/99 (1.01%) 
Cerebral infarction   0/107 (0.00%)  2/99 (2.02%) 
Cerebral ischemia   1/107 (0.93%)  0/99 (0.00%) 
Cerebral microhemorrhage   1/107 (0.93%)  0/99 (0.00%) 
Cerebrovascular accident   1/107 (0.93%)  0/99 (0.00%) 
Coma   1/107 (0.93%)  0/99 (0.00%) 
Complex regional pain syndrome   1/107 (0.93%)  3/99 (3.03%) 
Confusional state   1/107 (0.93%)  0/99 (0.00%) 
Convulsion   5/107 (4.67%)  2/99 (2.02%) 
Cytotoxic edema   0/107 (0.00%)  1/99 (1.01%) 
Dementia   1/107 (0.93%)  0/99 (0.00%) 
Dizziness   4/107 (3.74%)  2/99 (2.02%) 
Dysarthria   1/107 (0.93%)  1/99 (1.01%) 
Encephalopathy   0/107 (0.00%)  4/99 (4.04%) 
Epilepsy   1/107 (0.93%)  0/99 (0.00%) 
Haemorrhage intracranial   5/107 (4.67%)  3/99 (3.03%) 
Haemorrhagic tranformation stroke   25/107 (23.36%)  16/99 (16.16%) 
Headache   11/107 (10.28%)  14/99 (14.14%) 
Hydrocephalus   1/107 (0.93%)  0/99 (0.00%) 
Intracranial pressure increased   0/107 (0.00%)  1/99 (1.01%) 
Lethargy   0/107 (0.00%)  1/99 (1.01%) 
Mental impairment   0/107 (0.00%)  1/99 (1.01%) 
Monoplegia   0/107 (0.00%)  1/99 (1.01%) 
Muscle spasticity   1/107 (0.93%)  3/99 (3.03%) 
Muscular weakness   1/107 (0.93%)  0/99 (0.00%) 
Nervous system disorder   1/107 (0.93%)  1/99 (1.01%) 
Neuralgia   2/107 (1.87%)  0/99 (0.00%) 
Neurogenic bladder   0/107 (0.00%)  1/99 (1.01%) 
Neurogenic bowel   0/107 (0.00%)  1/99 (1.01%) 
Neurological decompensation   6/107 (5.61%)  9/99 (9.09%) 
Neurological symptom   0/107 (0.00%)  1/99 (1.01%) 
Paraesthesia   0/107 (0.00%)  1/99 (1.01%) 
Restless leg syndrome   0/107 (0.00%)  1/99 (1.01%) 
Restlessness   1/107 (0.93%)  0/99 (0.00%) 
Sleep apnoea syndrome   2/107 (1.87%)  1/99 (1.01%) 
Somnolence   0/107 (0.00%)  1/99 (1.01%) 
Stroke in evolution   3/107 (2.80%)  5/99 (5.05%) 
Subarachnoid haemorrhage   1/107 (0.93%)  0/99 (0.00%) 
Transient ischaemic attack   0/107 (0.00%)  1/99 (1.01%) 
Psychiatric disorders     
Agitation   6/107 (5.61%)  6/99 (6.06%) 
Anxiety   2/107 (1.87%)  2/99 (2.02%) 
Anxiety disorder   1/107 (0.93%)  0/99 (0.00%) 
Delirium   2/107 (1.87%)  4/99 (4.04%) 
Depressed mood   1/107 (0.93%)  1/99 (1.01%) 
Depression   6/107 (5.61%)  12/99 (12.12%) 
Hallucination   0/107 (0.00%)  1/99 (1.01%) 
Insomnia   5/107 (4.67%)  4/99 (4.04%) 
Mental status change   1/107 (0.93%)  0/99 (0.00%) 
Somnolence   1/107 (0.93%)  0/99 (0.00%) 
Renal and urinary disorders     
Haematuria   5/107 (4.67%)  1/99 (1.01%) 
Renal failure   1/107 (0.93%)  0/99 (0.00%) 
Renal failure acute   6/107 (5.61%)  7/99 (7.07%) 
Renal tubular necrosis   0/107 (0.00%)  1/99 (1.01%) 
Urinary retention   6/107 (5.61%)  9/99 (9.09%) 
Reproductive system and breast disorders     
Acquired phimosis   0/107 (0.00%)  1/99 (1.01%) 
Benign prostatic hypertrophy   0/107 (0.00%)  1/99 (1.01%) 
Penis disorder   1/107 (0.93%)  0/99 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure   1/107 (0.93%)  5/99 (5.05%) 
Aspiratoin   0/107 (0.00%)  1/99 (1.01%) 
Asthma   0/107 (0.00%)  1/99 (1.01%) 
Atelectasis   1/107 (0.93%)  2/99 (2.02%) 
Bronchitis chronic   0/107 (0.00%)  1/99 (1.01%) 
Cough   2/107 (1.87%)  1/99 (1.01%) 
Dyspnoea   0/107 (0.00%)  2/99 (2.02%) 
Epistaxis   2/107 (1.87%)  0/99 (0.00%) 
Hypercapnia   1/107 (0.93%)  0/99 (0.00%) 
Hypoxia   2/107 (1.87%)  2/99 (2.02%) 
Laryngeal oedema   1/107 (0.93%)  0/99 (0.00%) 
Lung consolidation   0/107 (0.00%)  1/99 (1.01%) 
Lung disorder   3/107 (2.80%)  6/99 (6.06%) 
Nasal congestion   1/107 (0.93%)  0/99 (0.00%) 
Pleural effusion   1/107 (0.93%)  4/99 (4.04%) 
Pneumonia aspiration   2/107 (1.87%)  8/99 (8.08%) 
Pneumothorax   1/107 (0.93%)  0/99 (0.00%) 
Pulmonary congestion   0/107 (0.00%)  1/99 (1.01%) 
Pulmonary embolism   2/107 (1.87%)  0/99 (0.00%) 
Respiration abnormal   1/107 (0.93%)  0/99 (0.00%) 
Respiratory acidosis   1/107 (0.93%)  0/99 (0.00%) 
Respiratory distress   1/107 (0.93%)  1/99 (1.01%) 
Respiratory failure   4/107 (3.74%)  1/99 (1.01%) 
Respiratory tract congestion   0/107 (0.00%)  1/99 (1.01%) 
Respiratory tract oedema   0/107 (0.00%)  1/99 (1.01%) 
Rhonchi   1/107 (0.93%)  0/99 (0.00%) 
Tachypnoea   1/107 (0.93%)  0/99 (0.00%) 
Upper respiratory tract infection   1/107 (0.93%)  0/99 (0.00%) 
Wheezing   1/107 (0.93%)  2/99 (2.02%) 
Skin and subcutaneous tissue disorders     
Blister   0/107 (0.00%)  1/99 (1.01%) 
Decubitus ulcer   0/107 (0.00%)  1/99 (1.01%) 
Erythema   0/107 (0.00%)  1/99 (1.01%) 
Panniculitis   0/107 (0.00%)  1/99 (1.01%) 
Rash   1/107 (0.93%)  5/99 (5.05%) 
Skin irritation   1/107 (0.93%)  0/99 (0.00%) 
Skin lesion   1/107 (0.93%)  0/99 (0.00%) 
Surgical and medical procedures     
Catheter management   0/107 (0.00%)  1/99 (1.01%) 
Tooth extraction   0/107 (0.00%)  1/99 (1.01%) 
Tumour excision   1/107 (0.93%)  0/99 (0.00%) 
Vascular disorders     
Aneurysm   0/107 (0.00%)  1/99 (1.01%) 
Arteriosclerosis   0/107 (0.00%)  1/99 (1.01%) 
Deep vein thrombosis   5/107 (4.67%)  3/99 (3.03%) 
Haemorrhage   0/107 (0.00%)  1/99 (1.01%) 
Hypertension   9/107 (8.41%)  8/99 (8.08%) 
Hypotension   15/107 (14.02%)  8/99 (8.08%) 
Orthostatic hypotension   1/107 (0.93%)  1/99 (1.01%) 
Peripheral coldness   0/107 (0.00%)  1/99 (1.01%) 
Phlebitis   1/107 (0.93%)  1/99 (1.01%) 
Shock   2/107 (1.87%)  0/99 (0.00%) 
Thrombophlebitis superficial   1/107 (0.93%)  3/99 (3.03%) 
Vascular dissection   1/107 (0.93%)  0/99 (0.00%) 
Vasospasm   3/107 (2.80%)  0/99 (0.00%) 
Vessel puncture site haemorrhage   1/107 (0.93%)  0/99 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Physician shall not make any publication without providing Sponsor 60 days notice. If Sponsor determines that the proposed publication contains confidential information, Sponsor may require the delay of publication for a period of time not to exceed 90 days and may require that any confidential information be removed from the publication. Sponsor may also require Physician to delay publication until any factual errors or inaccuracies in the publication are corrected.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cheryl Fontana, Sr. Manager, Clinical Services
Organization: Stryker Neurovascular
Phone: 510-413-2948
EMail: cheryl.fontana1@stryker.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02142283    
Other Study ID Numbers: T4024
First Submitted: May 15, 2014
First Posted: May 20, 2014
Results First Submitted: May 15, 2018
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018