Trial Outcomes & Findings for Trevo® Retriever Registry Post Market Surveillance (NCT NCT02040259)
NCT ID: NCT02040259
Last Updated: 2020-06-24
Results Overview
The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score (mTICI). Per protocol, successful revascularization is defined as having a modified TICI score ≥2b at the end of the procedure. Modified TICI Scale (mTICI Scale) Grade 0 - No Perfusion Grade 1 - Penetration with Minimal Perfusion Grade 2 - Partial Perfusion Grade 2a - Only partial filling (\< 50%) of the entire vascular territory is visualized. Grade 2b - Filling of \> 50% all of the expected vascular territory is visualized, but the filling is slower than normal. Grade 3 - Complete Perfusion
Recruitment status
COMPLETED
Target enrollment
2008 participants
Primary outcome timeframe
Post Procedure
Results posted on
2020-06-24
Participant Flow
The Trevo Retriever Registry was a prospective, open-label, consecutive enrollment, multi-center international registry designed to enroll up to 2,000 subjects at up to 100 clinical sites worldwide.
Participant milestones
| Measure |
Mechanical Thrombectomy, Trevo Retriever
The Trevo Retriever registry was a prospective, open-label, consecutive enrollment, multi-center global registry to assess real world performance of the Trevo Retriever which is intended to restore blood flow in the neurovasculature be removing thrombus in subjects experiencing ischemic stroke
|
|---|---|
|
Overall Study
STARTED
|
2008
|
|
Overall Study
COMPLETED
|
1645
|
|
Overall Study
NOT COMPLETED
|
363
|
Reasons for withdrawal
| Measure |
Mechanical Thrombectomy, Trevo Retriever
The Trevo Retriever registry was a prospective, open-label, consecutive enrollment, multi-center global registry to assess real world performance of the Trevo Retriever which is intended to restore blood flow in the neurovasculature be removing thrombus in subjects experiencing ischemic stroke
|
|---|---|
|
Overall Study
Death
|
280
|
|
Overall Study
Lost to Follow-up
|
76
|
|
Overall Study
Assessment not completed
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Trevo Retriever
n=2008 Participants
Mechanical thrombectomy, Trevo Retriever
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2008 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
735 Participants
n=2008 Participants
|
|
Age, Categorical
>=65 years
|
1273 Participants
n=2008 Participants
|
|
Age, Continuous
|
68.3 Years
STANDARD_DEVIATION 14.4 • n=2008 Participants
|
|
Sex: Female, Male
Female
|
1041 Participants
n=2008 Participants
|
|
Sex: Female, Male
Male
|
967 Participants
n=2008 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=2008 Participants
|
|
Region of Enrollment
South Korea
|
27 participants
n=2008 Participants
|
|
Region of Enrollment
Singapore
|
8 participants
n=2008 Participants
|
|
Region of Enrollment
Hungary
|
28 participants
n=2008 Participants
|
|
Region of Enrollment
United States
|
1365 participants
n=2008 Participants
|
|
Region of Enrollment
Czechia
|
131 participants
n=2008 Participants
|
|
Region of Enrollment
Italy
|
12 participants
n=2008 Participants
|
|
Region of Enrollment
France
|
183 participants
n=2008 Participants
|
|
Region of Enrollment
Thailand
|
20 participants
n=2008 Participants
|
|
Region of Enrollment
Switzerland
|
9 participants
n=2008 Participants
|
|
Region of Enrollment
Germany
|
83 participants
n=2008 Participants
|
|
Region of Enrollment
Spain
|
134 participants
n=2008 Participants
|
PRIMARY outcome
Timeframe: Post ProcedurePopulation: Intention to Treat (ITT)
The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score (mTICI). Per protocol, successful revascularization is defined as having a modified TICI score ≥2b at the end of the procedure. Modified TICI Scale (mTICI Scale) Grade 0 - No Perfusion Grade 1 - Penetration with Minimal Perfusion Grade 2 - Partial Perfusion Grade 2a - Only partial filling (\< 50%) of the entire vascular territory is visualized. Grade 2b - Filling of \> 50% all of the expected vascular territory is visualized, but the filling is slower than normal. Grade 3 - Complete Perfusion
Outcome measures
| Measure |
Mechanical Thrombectomy, Trevo Retriever
n=2008 Participants
Study participants undergoing mechanical thrombectomy, with the Trevo Retriever
|
|---|---|
|
Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score
|
1863 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Per Protocol. This endpoint includes patient with a baseline and 90 day assessment. 1997 participants that underwent mechanical thrombectomy with the Trevo retriever completed both assessments.
The Modified Rankin Scale 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 of neurological disability. A good clinical outcome = mRS scale 0-2. 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 |
Mechanical Thrombectomy, Trevo Retriever
n=1997 Participants
Study participants undergoing mechanical thrombectomy, with the Trevo Retriever
|
|---|---|
|
Modified Rankin Scale (mRS) Assessment at 90 Days
|
1104 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Intention to Treat (ITT)
Overall mortality rate
Outcome measures
| Measure |
Mechanical Thrombectomy, Trevo Retriever
n=2008 Participants
Study participants undergoing mechanical thrombectomy, with the Trevo Retriever
|
|---|---|
|
All Cause Mortality
|
280 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Intention to Treat (ITT)
Rate of Device and Procedure related serious adverse events (SAE)
Outcome measures
| Measure |
Mechanical Thrombectomy, Trevo Retriever
n=2008 Participants
Study participants undergoing mechanical thrombectomy, with the Trevo Retriever
|
|---|---|
|
Device and Procedure Related Serious Adverse Events (SAEs)
|
49 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Intention to Treat
Neurological Deterioration at 24 hours post procedure, defined as a 4 point or more increase in the NIHSS score over the baseline score.
Outcome measures
| Measure |
Mechanical Thrombectomy, Trevo Retriever
n=2008 Participants
Study participants undergoing mechanical thrombectomy, with the Trevo Retriever
|
|---|---|
|
Neurological Deterioration at 24 Hours
|
97 Participants
|
Adverse Events
Mechanical Thrombectomy, Trevo Retriever
Serious events: 427 serious events
Other events: 174 other events
Deaths: 280 deaths
Serious adverse events
| Measure |
Mechanical Thrombectomy, Trevo Retriever
n=2008 participants at risk
The Trevo Retriever registry was a prospective, open-label, consecutive enrollment, multi-center global registry to assess real world performance of the Trevo Retriever which is intended to restore blood flow in the neurovasculature be removing thrombus in subjects experiencing ischemic stroke
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
4/2008 • 90 days
|
|
Cardiac disorders
Angina pectoris
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.25%
5/2008 • 90 days
|
|
Cardiac disorders
Atrial septal defect
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Bradycardia
|
0.10%
2/2008 • 90 days
|
|
Cardiac disorders
Cardiac arrest
|
1.00%
20/2008 • 90 days
|
|
Cardiac disorders
Cardiac disorder
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Cardiac failure
|
0.40%
8/2008 • 90 days
|
|
Cardiac disorders
Cardiac failure acute
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.35%
7/2008 • 90 days
|
|
Cardiac disorders
Cardiac valve disease
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Cardio respiratory arrest
|
0.30%
6/2008 • 90 days
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.15%
3/2008 • 90 days
|
|
Cardiac disorders
Intracardiac thrombus
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Mitral valve incompetence
|
0.10%
2/2008 • 90 days
|
|
Cardiac disorders
Mitral valve stenosis
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
4/2008 • 90 days
|
|
Cardiac disorders
Palpitations
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Pulseless electrical activity
|
0.20%
4/2008 • 90 days
|
|
Cardiac disorders
Sick sinus syndrome
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Ventricular fibrillation
|
0.05%
1/2008 • 90 days
|
|
Congenital, familial and genetic disorders
Factor V Leiden mutation
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.15%
3/2008 • 90 days
|
|
Gastrointestinal disorders
Intestinal ichaemia
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Nausea
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
2/2008 • 90 days
|
|
Gastrointestinal disorders
Perirectal abscess
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.05%
1/2008 • 90 days
|
|
General disorders
Asthenia
|
0.05%
1/2008 • 90 days
|
|
General disorders
Autonomic nervous system imbalance
|
0.05%
1/2008 • 90 days
|
|
General disorders
Chest pain
|
0.05%
1/2008 • 90 days
|
|
General disorders
Death
|
0.55%
11/2008 • 90 days
|
|
General disorders
Delirium tremens
|
0.05%
1/2008 • 90 days
|
|
General disorders
General physical health deterioration
|
0.05%
1/2008 • 90 days
|
|
General disorders
Multi-organ failure
|
0.05%
1/2008 • 90 days
|
|
General disorders
Organ failure
|
0.05%
1/2008 • 90 days
|
|
Hepatobiliary disorders
Liver abscess
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Cellulitis
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Cholecystitis infective
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Cholstridium difficule infection
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Endocarditis
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Incision site infection
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Lung infection
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Pneumonia
|
0.85%
17/2008 • 90 days
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Pyelonephritis acute
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Respiratory tract infection
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Sepsis
|
0.70%
14/2008 • 90 days
|
|
Infections and infestations
Septic shock
|
0.35%
7/2008 • 90 days
|
|
Infections and infestations
Staphylococcal infections
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Urinary tract infection
|
0.20%
4/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.05%
1/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Complications of transplanted heart
|
0.05%
1/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Overdose
|
0.05%
1/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.05%
1/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Traumatic intracranial hemmorrhage
|
0.05%
1/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.35%
7/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoneurysm
|
0.05%
1/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Vessel perforation
|
0.40%
8/2008 • 90 days
|
|
Investigations
Haemoglobin decreased
|
0.05%
1/2008 • 90 days
|
|
Investigations
International normalised ratio abnormal
|
0.05%
1/2008 • 90 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.05%
1/2008 • 90 days
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.10%
2/2008 • 90 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.05%
1/2008 • 90 days
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.05%
1/2008 • 90 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.05%
1/2008 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.05%
1/2008 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gliblastoma
|
0.05%
1/2008 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.05%
1/2008 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mestastases to liver
|
0.05%
1/2008 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.05%
1/2008 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.05%
1/2008 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.05%
1/2008 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.05%
1/2008 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Basilar artery occlusion
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Brain death
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Brain herniation
|
0.10%
2/2008 • 90 days
|
|
Nervous system disorders
Brain oedema
|
0.90%
18/2008 • 90 days
|
|
Nervous system disorders
Carotid artery occlusion
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Carotid artery stenosis
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Cerebral artery embolism
|
0.15%
3/2008 • 90 days
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Cerebral artery thrombosis
|
0.10%
2/2008 • 90 days
|
|
Nervous system disorders
Cerebral haematoma
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Cerebral hyperperfusion syndrome
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.50%
10/2008 • 90 days
|
|
Nervous system disorders
Coma
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Complex partial seizures
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Convulsion
|
0.20%
4/2008 • 90 days
|
|
Nervous system disorders
Dementia
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Dizziness
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Encephalopathy
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Facial paralysis
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Gasping syndrome
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.5%
51/2008 • 90 days
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Headache
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Hypoaesthesia
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.25%
5/2008 • 90 days
|
|
Nervous system disorders
Neurological decompensation
|
4.8%
96/2008 • 90 days
|
|
Nervous system disorders
Partial seizures
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Presyncope
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Sedation
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Seizure
|
0.10%
2/2008 • 90 days
|
|
Nervous system disorders
Stroke in evolution
|
0.25%
5/2008 • 90 days
|
|
Nervous system disorders
Transient Ischaemic attach
|
0.10%
2/2008 • 90 days
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.05%
1/2008 • 90 days
|
|
Psychiatric disorders
Mental status changes
|
0.15%
3/2008 • 90 days
|
|
Renal and urinary disorders
Haematuria
|
0.05%
1/2008 • 90 days
|
|
Renal and urinary disorders
Renal failure
|
0.20%
4/2008 • 90 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.05%
1/2008 • 90 days
|
|
Renal and urinary disorders
Renal impairment
|
0.05%
1/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.85%
17/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.05%
1/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.10%
2/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.05%
1/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.15%
3/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.05%
1/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.15%
3/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.05%
1/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.55%
11/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
5/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.05%
1/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.65%
13/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
27/2008 • 90 days
|
|
Social circumstances
Homicide
|
0.05%
1/2008 • 90 days
|
|
Surgical and medical procedures
Mitral valve replacement
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Artery dissection
|
0.15%
3/2008 • 90 days
|
|
Vascular disorders
Cardiogenic shock
|
0.10%
2/2008 • 90 days
|
|
Vascular disorders
Cerebral artery embolism
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Cerebral artery thrombosis
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Cerebral haematoma
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Cerebral infarction
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Coeliac artery stenosis
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
2/2008 • 90 days
|
|
Vascular disorders
Extravasation blood
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Haematoma
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Haemorrhage
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Hypotension
|
0.15%
3/2008 • 90 days
|
|
Vascular disorders
Peripheral ischaemia
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Shock
|
0.20%
4/2008 • 90 days
|
|
Vascular disorders
Subarachnoid haemorrhage
|
0.10%
2/2008 • 90 days
|
|
Vascular disorders
Syncope
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Vascular dissection
|
0.25%
5/2008 • 90 days
|
Other adverse events
| Measure |
Mechanical Thrombectomy, Trevo Retriever
n=2008 participants at risk
The Trevo Retriever registry was a prospective, open-label, consecutive enrollment, multi-center global registry to assess real world performance of the Trevo Retriever which is intended to restore blood flow in the neurovasculature be removing thrombus in subjects experiencing ischemic stroke
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.05%
1/2008 • 90 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.05%
1/2008 • 90 days
|
|
Blood and lymphatic system disorders
Normachromic normocytic anaemia
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.30%
6/2008 • 90 days
|
|
Cardiac disorders
Atrioventricular block
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Bradycardia
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Pulmonary oedema
|
0.05%
1/2008 • 90 days
|
|
Cardiac disorders
Tachycardia
|
0.05%
1/2008 • 90 days
|
|
Eye disorders
Eye inflammation
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Colitis
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.05%
1/2008 • 90 days
|
|
Gastrointestinal disorders
Swollen tongue
|
0.05%
1/2008 • 90 days
|
|
General disorders
Extravasation
|
0.05%
1/2008 • 90 days
|
|
General disorders
Tobacco withdrawal symptoms
|
0.05%
1/2008 • 90 days
|
|
General disorders
Vessel puncture site haematoma
|
0.05%
1/2008 • 90 days
|
|
Immune system disorders
Drug hypersenitivity
|
0.05%
1/2008 • 90 days
|
|
Immune system disorders
Hypersensitivity
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Abscess
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Bacteraemia
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Herpes virus infection
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Hypersensitivity
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Pneumonia
|
0.25%
5/2008 • 90 days
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Sepsis
|
0.05%
1/2008 • 90 days
|
|
Infections and infestations
Urinary tract infection
|
0.70%
14/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.05%
1/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.05%
1/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.05%
1/2008 • 90 days
|
|
Injury, poisoning and procedural complications
Vessel perforation
|
0.25%
5/2008 • 90 days
|
|
Investigations
Blood pressure increased
|
0.05%
1/2008 • 90 days
|
|
Metabolism and nutrition disorders
Gout
|
0.05%
1/2008 • 90 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.15%
3/2008 • 90 days
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.05%
1/2008 • 90 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.05%
1/2008 • 90 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.10%
2/2008 • 90 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.05%
1/2008 • 90 days
|
|
Metabolism and nutrition disorders
Magnesium metabolism disorder
|
0.05%
1/2008 • 90 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.05%
1/2008 • 90 days
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.05%
1/2008 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.05%
1/2008 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial germ cell tumour
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Basal ganglia infarction
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Carotid artery occlusion
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Cerebral artery embolism
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Cerebral haematoma
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Cerebral infarction
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Cerebral vasoconstriction
|
0.50%
10/2008 • 90 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.10%
2/2008 • 90 days
|
|
Nervous system disorders
Confusional state
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Convulsion
|
0.10%
2/2008 • 90 days
|
|
Nervous system disorders
Dizziness
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Epilepsy
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.65%
13/2008 • 90 days
|
|
Nervous system disorders
Headache
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Hydrocephalus
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Intracranial pressure increased
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.05%
1/2008 • 90 days
|
|
Nervous system disorders
Neurological decompensation
|
2.7%
54/2008 • 90 days
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.10%
2/2008 • 90 days
|
|
Renal and urinary disorders
Anuria
|
0.05%
1/2008 • 90 days
|
|
Renal and urinary disorders
Dysuria
|
0.05%
1/2008 • 90 days
|
|
Renal and urinary disorders
Haematuria
|
0.05%
1/2008 • 90 days
|
|
Renal and urinary disorders
Renal failure
|
0.05%
1/2008 • 90 days
|
|
Renal and urinary disorders
Urinary retention
|
0.15%
3/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.05%
1/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.05%
1/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.05%
1/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.10%
2/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
3/2008 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.15%
3/2008 • 90 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.05%
1/2008 • 90 days
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Artery dissection
|
0.10%
2/2008 • 90 days
|
|
Vascular disorders
Cerebral artery embolism
|
0.10%
2/2008 • 90 days
|
|
Vascular disorders
Cerebral artery thrombosis
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Cerebral haemorrhage
|
0.10%
2/2008 • 90 days
|
|
Vascular disorders
Haemorrhage intracranial
|
0.65%
13/2008 • 90 days
|
|
Vascular disorders
Haemorrhagic transformation stroke
|
0.15%
3/2008 • 90 days
|
|
Vascular disorders
Mouth haemorrhages
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Subarachnoid haemorrhage
|
0.25%
5/2008 • 90 days
|
|
Vascular disorders
Uterine haemorrhage
|
0.05%
1/2008 • 90 days
|
|
Vascular disorders
Vascular dissection
|
0.15%
3/2008 • 90 days
|
|
General disorders
Pyrexia
|
0.05%
1/2008 • 90 days
|
Additional Information
Minyi Ji, Biostatistician, Clinical Evidence
Stryker Neurovascular
Phone: +1 (510) 980-5689
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