Study: NCT02536378

Adverse event: Cranial nerve injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Injury to cranial nerves in the vicinity of the treated carotid artery that has not resolved by one month after the initial procedure.
Frequency: 8 affected / 632 at risk

Adverse event: Death - Other
Serious: yes
Organ System: General disorders
Notes: Death that cannot be attributed to neurologic or cardiac causes
Frequency: 1 affected / 632 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Myocardial ischemia with elevation of cardiac enzymes (CK-MB or troponin) to a value 2 or more times the individual clinical center's laboratory upper limit of normal
Frequency: 6 affected / 632 at risk

Adverse event: NPS Device Related Event
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes dissection and any vascular complication that may be attributed to the procedure or devices
Frequency: 2 affected / 632 at risk

Adverse event: Stroke - Contralateral
Serious: yes
Organ System: Nervous system disorders
Notes: A neurological deficit attributed to an acute focal injury of the central nervous system contralateral to the vessel being stented.
Frequency: 1 affected / 632 at risk

Adverse event: Stroke - Ipsilateral
Serious: yes
Organ System: Nervous system disorders
Notes: A neurological deficit attributed to an acute focal injury of the central nervous system ipsilateral to the vessel being stented
Frequency: 3 affected / 632 at risk

Adverse event: Possibly NPS/Stent device related event
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes dissection, and any vascular complication that may be attributed to the procedure or devices
Frequency: 5 affected / 632 at risk

Adverse event: Stent Device Related Event
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes thrombus formation, and any vascular complication that may be attributed to the procedure or devices
Frequency: 1 affected / 632 at risk

Adverse event: Cranial nerve injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Injury to cranial nerves in the vicinity of the treated carotid artery that has not resolved by one month after the initial procedure.
Frequency: 10 affected / 692 at risk

Adverse event: Death - Neurological
Serious: yes
Organ System: Nervous system disorders
Notes: Death due to stroke or other neurologic cause
Frequency: 2 affected / 692 at risk

Adverse event: Death - Other
Serious: yes
Organ System: General disorders
Notes: Death that cannot be attributed to neurologic or cardiac causes
Frequency: 1 affected / 692 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Myocardial ischemia with elevation of cardiac enzymes (CK-MB or troponin) to a value 2 or more times the individual clinical center's laboratory upper limit of normal
Frequency: 7 affected / 692 at risk

Adverse event: NPS Device Related Event
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes dissection and any vascular complication that may be attributed to the procedure or devices
Frequency: 2 affected / 692 at risk

Adverse event: Stroke - Contralateral
Serious: yes
Organ System: Nervous system disorders
Notes: A neurological deficit attributed to an acute focal injury of the central nervous system contralateral to the vessel being stented.
Frequency: 1 affected / 692 at risk

Adverse event: Stroke - Ipsilateral
Serious: yes
Organ System: Nervous system disorders
Notes: A neurological deficit attributed to an acute focal injury of the central nervous system ipsilateral to the vessel being stented
Frequency: 14 affected / 692 at risk

Adverse event: Possibly NPS/Stent device related event
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes dissection, and any vascular complication that may be attributed to the procedure or devices
Frequency: 7 affected / 692 at risk

Adverse event: Stent Device Related Event
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes thrombus formation, and any vascular complication that may be attributed to the procedure or devices
Frequency: 1 affected / 692 at risk