Trial Outcomes & Findings for Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo (NCT NCT02142283)
NCT ID: NCT02142283
Last Updated: 2018-07-20
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
206 participants
Primary outcome timeframe
90 days
Results posted on
2018-07-20
Participant Flow
See protocol
See protocol
Participant milestones
| Measure |
Trevo Thrombectomy Procedure
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
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
99
|
|
Overall Study
COMPLETED
|
86
|
78
|
|
Overall Study
NOT COMPLETED
|
21
|
21
|
Reasons for withdrawal
| Measure |
Trevo Thrombectomy Procedure
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
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
Overall Study
Death
|
20
|
18
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo
Baseline characteristics by cohort
| Measure |
Trevo Thrombectomy Procedure
n=107 Participants
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
n=99 Participants
Medical Management
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 Years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
70.7 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
70.0 Years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: ITT
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
Outcome measures
| Measure |
Trevo Thrombectomy Procedure
n=107 Participants
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
n=99 Participants
Medical Management
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome
|
5.5 score on a scale
Standard Deviation 3.8
|
3.4 score on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: 90 daysPopulation: ITT
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
Outcome measures
| Measure |
Trevo Thrombectomy Procedure
n=107 Participants
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
n=99 Participants
Medical Management
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome
|
52 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: ITT
Outcome measures
| Measure |
Trevo Thrombectomy Procedure
n=107 Participants
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
n=99 Participants
Medical Management
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
Stroke-related Mortality, Primary Safety Outcome
|
17 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: ITT
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
Outcome measures
| Measure |
Trevo Thrombectomy Procedure
n=107 Participants
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
n=99 Participants
Medical Management
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
Good Functional Outcome
|
52 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 5-7 DaysThe 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.
Outcome measures
| Measure |
Trevo Thrombectomy Procedure
n=107 Participants
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
n=99 Participants
Medical Management
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
Early Response
|
51 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: ITT
Outcome measures
| Measure |
Trevo Thrombectomy Procedure
n=107 Participants
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
n=99 Participants
Medical Management
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
All Cause Mortality
|
20 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: ITT
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.
Outcome measures
| Measure |
Trevo Thrombectomy Procedure
n=107 Participants
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
n=99 Participants
Medical Management
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
Revascularization Rates
|
82 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 5-7 daysPopulation: ITT
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.
Outcome measures
| Measure |
Trevo Thrombectomy Procedure
n=107 Participants
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
n=99 Participants
Medical Management
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
Neurological Deterioration From Baseline NIHSS Score
|
15 Participants
|
26 Participants
|
Adverse Events
Trevo Thrombectomy Procedure
Serious events: 41 serious events
Other events: 102 other events
Deaths: 20 deaths
Medical Management
Serious events: 47 serious events
Other events: 91 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Trevo Thrombectomy Procedure
n=107 participants at risk
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
n=99 participants at risk
Medical Management
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
Blood and lymphatic system disorders
Chronic lymphocytic leukaemia
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Cardiac disorders
Cardiac arrest
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Cardiac disorders
Cardiac failure
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Chest pain
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Cardiac disorders
Coronary artery stenosis
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Cardiac disorders
Pulmonary oedema
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Eye disorders
Retinal artery occlusion
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Gastrointestinal disorders
Dysphagia
|
4.7%
5/107 • 90 days
|
9.1%
9/99 • 90 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Infections and infestations
Pneumonia
|
5.6%
6/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Immune system disorders
Septic shock
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Injury, poisoning and procedural complications
Musculoskeletal pain
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Nervous system disorders
Aphasia
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Brain herniation
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Brain oedema
|
1.9%
2/107 • 90 days
|
5.1%
5/99 • 90 days
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Cerebral infarction
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Cerebrovascular accident
|
2.8%
3/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Convulsion
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Embolic stroke
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
2.8%
3/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Loss of consciousness
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Muscular weakness
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/107 • 90 days
|
9.1%
9/99 • 90 days
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Stroke in evolution
|
4.7%
5/107 • 90 days
|
9.1%
9/99 • 90 days
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Psychiatric disorders
Completed suicide
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.93%
1/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.8%
3/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.8%
3/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal oedema
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Surgical and medical procedures
Amputation
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.93%
1/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Vascular disorders
Hypotension
|
1.9%
2/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Vascular disorders
Shock
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Surgical and medical procedures
Cranioplasty
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
Other adverse events
| Measure |
Trevo Thrombectomy Procedure
n=107 participants at risk
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
n=99 participants at risk
Medical Management
Medical Management: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.7%
5/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.7%
5/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Aortic valve incompetence
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Arrhythmia
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Atrial fibrillation
|
13.1%
14/107 • 90 days
|
13.1%
13/99 • 90 days
|
|
Cardiac disorders
Bradycardia
|
1.9%
2/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Cardiac disorders
Cardiac failure
|
1.9%
2/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Cardiomegaly
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Intracardiac thrombus
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Left ventricular failure
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Cardiac disorders
Pulmonary oedema
|
2.8%
3/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Cardiac disorders
Tachycardia
|
1.9%
2/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Ventricular tachycardia
|
0.93%
1/107 • 90 days
|
4.0%
4/99 • 90 days
|
|
Endocrine disorders
Hypothyroidism
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Eye disorders
Cataract
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Eye disorders
Dry eye
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Gastrointestinal disorders
Constipation
|
9.3%
10/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Gastrointestinal disorders
Dental caries
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
4/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
7/107 • 90 days
|
13.1%
13/99 • 90 days
|
|
Gastrointestinal disorders
Gastric hypomotility
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Gastrointestinal disorders
Hiccups
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Gastrointestinal disorders
Ileus
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Gastrointestinal disorders
Nausea
|
7.5%
8/107 • 90 days
|
5.1%
5/99 • 90 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
5/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
General disorders
Chest pain
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
General disorders
Device occulsion
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
General disorders
Fatigue
|
2.8%
3/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
General disorders
Local swelling
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
General disorders
Oedema
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
General disorders
Oedema peripheral
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
General disorders
Pain
|
5.6%
6/107 • 90 days
|
8.1%
8/99 • 90 days
|
|
General disorders
Pyrexia
|
7.5%
8/107 • 90 days
|
5.1%
5/99 • 90 days
|
|
Infections and infestations
Bronchitis
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Infections and infestations
Cellulitis
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Infections and infestations
Conjunctivitis
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Infections and infestations
Erysipelas
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Infections and infestations
Fungal infection
|
0.93%
1/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Infections and infestations
Infection
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Infections and infestations
Influenza
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Infections and infestations
Mucosal infection
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Infections and infestations
Oral candidiasis
|
2.8%
3/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Infections and infestations
Penumonia
|
5.6%
6/107 • 90 days
|
8.1%
8/99 • 90 days
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Infections and infestations
Sepsis
|
1.9%
2/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Infections and infestations
Septic shock
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Infections and infestations
Sinusitis
|
0.93%
1/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Infections and infestations
Skin candida
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Infections and infestations
Staphylococcal infection
|
0.93%
1/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Infections and infestations
Urinary tract infection
|
20.6%
22/107 • 90 days
|
22.2%
22/99 • 90 days
|
|
Infections and infestations
Urosepsis
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Injury, poisoning and procedural complications
Fall
|
2.8%
3/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Injury, poisoning and procedural complications
Nephropathy toxic
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Injury, poisoning and procedural complications
Blood lactate dehydrogenase abnormal
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Injury, poisoning and procedural complications
Blood lactic acid increased
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Injury, poisoning and procedural complications
Cardiac enzymes increased
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Investigations
Computerised tomogram abnormal
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Investigations
Electroencephalogram abnormal
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Investigations
International normalized ratio increased
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Investigations
Investigation abnormal
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Investigations
Liver function analyses
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Investigations
Transaminases increased
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Investigations
Troponin increased
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Investigations
Weight decreased
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.9%
2/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Metabolism and nutrition disorders
Gout
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Hypercreatinaemia
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Metabolism and nutrition disorders
Hypergylcaemia
|
6.5%
7/107 • 90 days
|
6.1%
6/99 • 90 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.9%
2/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.8%
3/107 • 90 days
|
6.1%
6/99 • 90 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.5%
7/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.93%
1/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
2/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Metabolism and nutrition disorders
Monoarthritis
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.93%
1/107 • 90 days
|
4.0%
4/99 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.7%
5/107 • 90 days
|
7.1%
7/99 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Allodynia
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Basal ganglia infarction
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Brain herniation
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Brain oedema
|
4.7%
5/107 • 90 days
|
7.1%
7/99 • 90 days
|
|
Nervous system disorders
Carotid artery stenosis
|
2.8%
3/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Central pain syndrome
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Cerebral artery embolism
|
3.7%
4/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Nervous system disorders
Cerebral ischemia
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Cerebral microhemorrhage
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Coma
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.93%
1/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Nervous system disorders
Confusional state
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Convulsion
|
4.7%
5/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Nervous system disorders
Cytotoxic edema
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Dementia
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Dizziness
|
3.7%
4/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Nervous system disorders
Dysarthria
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/107 • 90 days
|
4.0%
4/99 • 90 days
|
|
Nervous system disorders
Epilepsy
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Haemorrhage intracranial
|
4.7%
5/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Nervous system disorders
Haemorrhagic tranformation stroke
|
23.4%
25/107 • 90 days
|
16.2%
16/99 • 90 days
|
|
Nervous system disorders
Headache
|
10.3%
11/107 • 90 days
|
14.1%
14/99 • 90 days
|
|
Nervous system disorders
Hydrocephalus
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Muscle spasticity
|
0.93%
1/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Nervous system disorders
Muscular weakness
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Nervous system disorder
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Neuralgia
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Neurogenic bladder
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Neurogenic bowel
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Neurological decompensation
|
5.6%
6/107 • 90 days
|
9.1%
9/99 • 90 days
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Restless leg syndrome
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Restlessness
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Sleep apnoea syndrome
|
1.9%
2/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Nervous system disorders
Stroke in evolution
|
2.8%
3/107 • 90 days
|
5.1%
5/99 • 90 days
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Psychiatric disorders
Agitation
|
5.6%
6/107 • 90 days
|
6.1%
6/99 • 90 days
|
|
Psychiatric disorders
Anxiety
|
1.9%
2/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Psychiatric disorders
Anxiety disorder
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Psychiatric disorders
Delirium
|
1.9%
2/107 • 90 days
|
4.0%
4/99 • 90 days
|
|
Psychiatric disorders
Depressed mood
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Psychiatric disorders
Depression
|
5.6%
6/107 • 90 days
|
12.1%
12/99 • 90 days
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Psychiatric disorders
Insomnia
|
4.7%
5/107 • 90 days
|
4.0%
4/99 • 90 days
|
|
Psychiatric disorders
Mental status change
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Psychiatric disorders
Somnolence
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Renal and urinary disorders
Haematuria
|
4.7%
5/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Renal and urinary disorders
Renal failure
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Renal and urinary disorders
Renal failure acute
|
5.6%
6/107 • 90 days
|
7.1%
7/99 • 90 days
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Renal and urinary disorders
Urinary retention
|
5.6%
6/107 • 90 days
|
9.1%
9/99 • 90 days
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Reproductive system and breast disorders
Benign prostatic hypertrophy
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Reproductive system and breast disorders
Penis disorder
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.93%
1/107 • 90 days
|
5.1%
5/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiratoin
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.93%
1/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
2/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
2/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.8%
3/107 • 90 days
|
6.1%
6/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.93%
1/107 • 90 days
|
4.0%
4/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.9%
2/107 • 90 days
|
8.1%
8/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Cardiac disorders
Artial flutter
|
1.9%
2/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Cardiac disorders
Artial tachycardia
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Cardiac disorders
Sick sinus syndrome
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Immune system disorders
Reaction to drug
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
29.9%
32/107 • 90 days
|
20.2%
20/99 • 90 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.93%
1/107 • 90 days
|
4.0%
4/99 • 90 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.6%
6/107 • 90 days
|
7.1%
7/99 • 90 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.8%
3/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.7%
4/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract oedema
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.93%
1/107 • 90 days
|
2.0%
2/99 • 90 days
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.93%
1/107 • 90 days
|
5.1%
5/99 • 90 days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Surgical and medical procedures
Catheter management
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Surgical and medical procedures
Tumour excision
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Vascular disorders
Aneurysm
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Vascular disorders
Deep vein thrombosis
|
4.7%
5/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Vascular disorders
Hypertension
|
8.4%
9/107 • 90 days
|
8.1%
8/99 • 90 days
|
|
Vascular disorders
Hypotension
|
14.0%
15/107 • 90 days
|
8.1%
8/99 • 90 days
|
|
Vascular disorders
Orthostatic hypotension
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Vascular disorders
Phlebitis
|
0.93%
1/107 • 90 days
|
1.0%
1/99 • 90 days
|
|
Vascular disorders
Shock
|
1.9%
2/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.93%
1/107 • 90 days
|
3.0%
3/99 • 90 days
|
|
Vascular disorders
Vascular dissection
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Vascular disorders
Vasospasm
|
2.8%
3/107 • 90 days
|
0.00%
0/99 • 90 days
|
|
Vascular disorders
Vessel puncture site haemorrhage
|
0.93%
1/107 • 90 days
|
0.00%
0/99 • 90 days
|
Additional Information
Cheryl Fontana, Sr. Manager, Clinical Services
Stryker Neurovascular
Phone: 510-413-2948
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER