Trial Outcomes & Findings for Solitaire FR Thrombectomy for Acute Revascularisation (NCT NCT01327989)
NCT ID: NCT01327989
Last Updated: 2017-01-27
Results Overview
Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion
Recruitment status
COMPLETED
Target enrollment
202 participants
Primary outcome timeframe
Immediately post procedure
Results posted on
2017-01-27
Participant Flow
Participant milestones
| Measure |
Solitaire™ FR Device
Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device
|
|---|---|
|
Overall Study
STARTED
|
202
|
|
Overall Study
COMPLETED
|
188
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Solitaire FR Thrombectomy for Acute Revascularisation
Baseline characteristics by cohort
| Measure |
Solitaire™ FR Device
n=202 Participants
Eligible subjects treated with the Solitaire™ FR device.
|
|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Gender
Female
|
122 Participants
n=5 Participants
|
|
Gender
Male
|
80 Participants
n=5 Participants
|
|
Modified Rankin Scale (mRS)
|
0.0 Scores on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately post procedurePopulation: Due to insufficient imaging, the Core Lab was able to evaluate data from 190 subjects.
Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion
Outcome measures
| Measure |
Solitaire™ FR Device
n=190 Participants
Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device
|
|---|---|
|
Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device.
|
84.2 percentage of particpants
|
PRIMARY outcome
Timeframe: 90 DaysDevice-related and procedure-related Serious Adverse Events (SAEs). A clinically significant procedure complication is defined as a decline in NIHSS of ≥4 or access vessel complication requiring surgery or blood transfusion.
Outcome measures
| Measure |
Solitaire™ FR Device
n=202 Participants
Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device
|
|---|---|
|
Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs).
|
7.4 percentage of events
|
SECONDARY outcome
Timeframe: During procedurePopulation: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.
Time from groin stick to initial angiogram and final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion
Outcome measures
| Measure |
Solitaire™ FR Device
n=194 Participants
Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device
|
|---|---|
|
Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram
|
29 Minutes
Standard Deviation 27
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.
Time after first ipsilateral angiogram to final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow Thrombolysis in Cerebral Infarction (TICI) score Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion
Outcome measures
| Measure |
Solitaire™ FR Device
n=201 Participants
Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device
|
|---|---|
|
Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram
|
37.2 Minutes
Standard Deviation 57.7
|
SECONDARY outcome
Timeframe: 90 DaysPopulation: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.
Good neurological outcome (GNO), as defined in the protocol, is a modified Rankin Scale (mRS) score of less than or equal to 2, or National Institutes of Health Stroke Scale (NIHSS) score 0-1, or NIHSS score improvement of 10 points or more from the pre-procedure evaluation
Outcome measures
| Measure |
Solitaire™ FR Device
n=169 Participants
Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device
|
|---|---|
|
Good Neurological Condition
|
88.2 percentage of particpants
|
SECONDARY outcome
Timeframe: 90 DaysOutcome measures
| Measure |
Solitaire™ FR Device
n=202 Participants
Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device
|
|---|---|
|
Rate of Morbidity
|
8.4 percentage of particpants
|
SECONDARY outcome
Timeframe: 90 DaysOutcome measures
| Measure |
Solitaire™ FR Device
n=202 Participants
Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device
|
|---|---|
|
Rate of Mortality
|
6.9 percentage of particpants
|
SECONDARY outcome
Timeframe: 24 hoursSymptomatic intracranial hemorrhage, defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a decline in National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24 hrs. PH1 - Hematoma within ischemic field with some mild space occupying effect but involving ≤ 30% PH2 - Hematoma within ischemic field with space-occupying effect involving \> 30% of the infarcted area RIH - Any intraparenchymal hemorrhage remote from the ischemic field IVH - Intraventricular hemorrhage SAH - Subarachnoid hemorrhage
Outcome measures
| Measure |
Solitaire™ FR Device
n=202 Participants
Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device
|
|---|---|
|
Incidence of Symptomatic Intracranial Hemorrhage
|
1.5 percentage of particpants
|
SECONDARY outcome
Timeframe: procedurePopulation: Due to insufficient imaging, the Core Lab was able to evaluated data from 190 subjects.
Immediate reperfusion observed when the Solitaire™ FR device is deployed within the thrombus - Thrombolysis in Cerebral Infarction (TICI) score 2b or 3. Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (\<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion
Outcome measures
| Measure |
Solitaire™ FR Device
n=190 Participants
Eligible subjects treated with the Solitaire™ FR device.
Solitaire™ FR device
|
|---|---|
|
Immediate Flow Reperfusion
|
11.6 percentage of participants
|
Adverse Events
Solitaire™ FR Device
Serious events: 59 serious events
Other events: 143 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Solitaire™ FR Device
n=202 participants at risk
Eligible subjects treated with the Solitaire™ FR device.
|
|---|---|
|
Nervous system disorders
Intracranial artery dissection
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Endocrine disorders
Hyperthyroidism
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Gastrointestinal disorders
Gallstone ileus
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
General disorders
Catheter site haematoma
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
General disorders
Death
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
General disorders
Thrombosis in device
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Bronchitis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Pneumonia
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Sepsis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Investigations
Electrocardiogram ST segment depression
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Investigations
Heart rate irregular
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Investigations
International normalised ratio increased
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Investigations
Pseudomonas test positive
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Hemiparesis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Brain oedema
|
1.5%
3/202 • Number of events 3 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.5%
3/202 • Number of events 3 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebral infarction
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Hemiplegia
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
3.0%
6/202 • Number of events 6 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Coma
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Convulsion
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Epilepsy
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Ischaemic stroke
|
2.0%
4/202 • Number of events 4 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Neurological decompensation
|
1.5%
3/202 • Number of events 3 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
2.0%
4/202 • Number of events 4 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Syncope
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Psychiatric disorders
Delirium tremens
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Psychiatric disorders
Mental status changes
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.5%
3/202 • Number of events 3 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Surgical and medical procedures
Cranioplasty
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Surgical and medical procedures
Gastrostomy tube insertion
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Surgical and medical procedures
Heart valve replacement
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Surgical and medical procedures
Tracheostomy
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Embolism
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Hypotension
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Vascular dissection
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Vessel perforation
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Investigations
Aspiration bronchial
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
Other adverse events
| Measure |
Solitaire™ FR Device
n=202 participants at risk
Eligible subjects treated with the Solitaire™ FR device.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
10/202 • Number of events 10 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Cardiac disorders
Cardiac failure
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Cardiac disorders
Left ventricular failure
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Cardiac disorders
Pericardial effusion
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Cardiac disorders
Tachycardia
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Eye disorders
Conjunctivitis
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Eye disorders
Diplopia
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Gastrointestinal disorders
Tongue haematoma
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
General disorders
Device leakage
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
General disorders
Adverse drug reaction
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
General disorders
Application site eczema
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
General disorders
Device difficult to use
|
0.99%
2/202 • Number of events 3 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
General disorders
Unevaluable event
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Bacterial prostatitis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Infection
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Lung infection
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Oral candidiasis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Oral fungal infection
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Parotitis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Pneumonia
|
1.5%
3/202 • Number of events 3 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Pneumonia bacterial
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Respiratory tract infection
|
3.5%
7/202 • Number of events 7 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Secondary syphilis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Skin infection
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Staphylococcal infection
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Urinary tract infection
|
6.9%
14/202 • Number of events 14 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Injury, poisoning and procedural complications
Injury
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Investigations
Aspiration bronchial
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Investigations
Brain natriuretic peptide increased
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Investigations
Haemoglobin decreased
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Investigations
Thyroid function test abnormal
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Metabolism and nutrition disorders
Gout
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Musculoskeletal and connective tissue disorders
CREST syndrome
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Altered state of consciousness
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Basilar artery stenosis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Brain oedema
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebral haematoma
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebral haemorrhage
|
16.8%
34/202 • Number of events 36 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Cerebrovascular spasm
|
1.5%
3/202 • Number of events 3 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Convulsion
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Epilepsy
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.5%
3/202 • Number of events 3 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
3.0%
6/202 • Number of events 6 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Headache
|
1.5%
3/202 • Number of events 3 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Intracranial artery dissection
|
2.0%
4/202 • Number of events 4 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Ischaemic stroke
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
IVth nerve paresis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
2.5%
5/202 • Number of events 5 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Syncope
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Tonic convulsion
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Vascular headache
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Psychiatric disorders
Agitation
|
2.0%
4/202 • Number of events 4 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Psychiatric disorders
Apathy
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Psychiatric disorders
Depression
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Psychiatric disorders
Hallucination
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Psychiatric disorders
Insomnia
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Psychiatric disorders
Mental status changes
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Psychiatric disorders
Post stroke depression
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Renal and urinary disorders
Leukocyturia
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
3.5%
7/202 • Number of events 7 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory fremitus
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Air embolism
|
1.5%
3/202 • Number of events 3 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Embolism
|
6.4%
13/202 • Number of events 13 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Hypertension
|
0.99%
2/202 • Number of events 2 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Hypertensive crisis
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Hypotension
|
0.50%
1/202 • Number of events 1 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Vascular dissection
|
1.5%
3/202 • Number of events 3 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
|
Vascular disorders
Vasospasm
|
26.7%
54/202 • Number of events 54 • 90 Days
Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
|
Additional Information
Manish Gupta, Sr. Director of Medical Affairs
Medtronic
Phone: 949-837-3700
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