Trial Outcomes & Findings for Neuroform Atlas Stent System Study (NCT NCT02340585)
NCT ID: NCT02340585
Last Updated: 2023-03-24
Results Overview
Any major ipsilateral stroke or neurological death
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
298 participants
Primary outcome timeframe
within 12 months of the index procedure
Results posted on
2023-03-24
Participant Flow
Participant milestones
| Measure |
Next Generation Neuroform Stent System
The Next Generation Stent System is a self-expanding, open cell, nitinol stent designed to provide support of the coil mass within the aneurysm and minimize stent deflection.
Next Generation Neuroform Stent System: The Next Generation Neuroform Stent System is pre-loaded on a stent delivery wire and protected by a transfer sheath. An accessory pouch containing an optional stabilizer may be attached to the proximal end of the stent delivery wire to facilitate handling and stabilization.
|
|---|---|
|
Anterior Cohort
STARTED
|
182
|
|
Anterior Cohort
COMPLETED
|
182
|
|
Anterior Cohort
NOT COMPLETED
|
0
|
|
Posterior Cohort
STARTED
|
116
|
|
Posterior Cohort
COMPLETED
|
116
|
|
Posterior Cohort
NOT COMPLETED
|
0
|
|
Post-approval Study (PAS)
STARTED
|
298
|
|
Post-approval Study (PAS)
COMPLETED
|
298
|
|
Post-approval Study (PAS)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuroform Atlas Stent System Study
Baseline characteristics by cohort
| Measure |
Next Generation Neuroform Stent System
n=298 Participants
The Next Generation Stent System is a self-expanding, open cell, nitinol stent designed to provide support of the coil mass within the aneurysm and minimize stent deflection.
Next Generation Neuroform Stent System: The Next Generation Neuroform Stent System is pre-loaded on a stent delivery wire and protected by a transfer sheath. An accessory pouch containing an optional stabilizer may be attached to the proximal end of the stent delivery wire to facilitate handling and stabilization.
|
|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 11.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
227 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
white
|
253 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
black
|
34 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: within 12 months of the index procedureAny major ipsilateral stroke or neurological death
Outcome measures
| Measure |
Neuroform Atlas Stent System (Anterior)
n=182 Participants
Neuroform Atlas Stent System (Anterior)
|
Neuroform Atlas Stent System (Posterior)
n=116 Participants
Neuroform Atlas Stent System (Posterior)
|
|---|---|---|
|
Stroke or Death
|
8 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 12 month post index procedureComplete aneurysm occlusion (100% occlusion - Raymond Class 1) of the treated target lesion on 12 month angiography, in the absence of retreatment, or parent artery stenosis (\> 50%) at the target location.
Outcome measures
| Measure |
Neuroform Atlas Stent System (Anterior)
n=153 Participants
Neuroform Atlas Stent System (Anterior)
|
Neuroform Atlas Stent System (Posterior)
n=95 Participants
Neuroform Atlas Stent System (Posterior)
|
|---|---|---|
|
Aneurysm Occlusion of the Treated Target Lesion on 12 Month Angiography
|
135 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: within 12 months post procedureThe percent of subjects experiencing one or more serious adverse events (SAEs) through 12 months including * New or worsening major ipsilateral stroke as measured by the National Institute of Health Stroke Scale (NIHSS) * Device-related SAEs * Subarachnoid hemorrhage (SAH) * Aneurysm rupture
Outcome measures
| Measure |
Neuroform Atlas Stent System (Anterior)
n=182 Participants
Neuroform Atlas Stent System (Anterior)
|
Neuroform Atlas Stent System (Posterior)
n=116 Participants
Neuroform Atlas Stent System (Posterior)
|
|---|---|---|
|
The Percent of Subjects Experiencing One or More Serious Adverse Events (SAEs) Through 12 Months
|
20 Participants
|
19 Participants
|
Adverse Events
Next Generation Neuroform Stent System
Serious events: 90 serious events
Other events: 212 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Next Generation Neuroform Stent System
n=298 participants at risk
The Next Generation Stent System is a self-expanding, open cell, nitinol stent designed to provide support of the coil mass within the aneurysm and minimize stent deflection.
Next Generation Neuroform Stent System: The Next Generation Neuroform Stent System is pre-loaded on a stent delivery wire and protected by a transfer sheath. An accessory pouch containing an optional stabilizer may be attached to the proximal end of the stent delivery wire to facilitate handling and stabilization.
|
|---|---|
|
Nervous system disorders
Cerebral artery embolism
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Cerebral infarction
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Embolic stroke
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Ischaemic stroke
|
3.7%
11/298 • Number of events 11 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.7%
5/298 • Number of events 5 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Transient ischaemic attack
|
2.3%
7/298 • Number of events 9 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Blood and lymphatic system disorders
Myelodysplastic Syndrome
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Cardiac disorders
Cardiomyopathy
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Cardiac disorders
Cardiac failure congestive
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
General disorders
Chest pain
|
1.7%
5/298 • Number of events 5 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Cardiac disorders
Myocardial infarction
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Endocrine disorders
Hypothyroidism
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Eye disorders
Blurred vision
|
0.67%
2/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Eye disorders
Diplopia
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Dysphagia
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Colitis ischemic
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Constipation
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Crohn's disease
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Diarrheic
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Diverticulitis intestinal hemmorhagic
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Gastrointestinal hemmorhage
|
0.67%
2/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
General disorders
Application site hematoma
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Hematemesis
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Infections and infestations
Human anaplasmosis
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Infections and infestations
Enterocolitis viral
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Infections and infestations
Groin infection
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Infections and infestations
Pelvic abcess
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Infections and infestations
Peritonitis
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Infections and infestations
Urinary tract infection
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Injury, poisoning and procedural complications
Fall
|
0.34%
1/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Injury, poisoning and procedural complications
Post-procedural complication
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.67%
2/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.67%
2/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Injury, poisoning and procedural complications
vessel perforation
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Metabolism and nutrition disorders
Inappropriate antidiurectic hormone secretion
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Musculoskeletal and connective tissue disorders
Muscle hemorrhage
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.34%
1/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Metabolism and nutrition disorders
Neck pain
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cyst
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Balance disorder
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Convulsion or seizure
|
1.3%
4/298 • Number of events 4 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Migraine or status migrainosis
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Headache
|
0.67%
2/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Hydrocephalus
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Parathesia
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Vertebral artery dissection
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Syncope
|
0.67%
2/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Presyncope
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.67%
2/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Speech disorder
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Intracranial aneurysm
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Psychiatric disorders
Delirium
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Renal and urinary disorders
Nephrogenic anemia
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Renal and urinary disorders
Acute renal failure
|
0.34%
1/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.67%
2/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Surgical and medical procedures
Carotid artery stent insertion
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Surgical and medical procedures
Angioplasty
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Surgical and medical procedures
Intracerebral aneurysm operation
|
6.0%
18/298 • Number of events 20 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Surgical and medical procedures
Colostomy
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Surgical and medical procedures
Peripheral artery stent insertion
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Surgical and medical procedures
Spinal operation
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Peripheral ischemia
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Carotid artery stenosis
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Retroperitoneal hemorrhage
|
0.67%
2/298 • Number of events 2 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Thrombosis in device
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Arteriosclerosis
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Deep vein thrombosis
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Hypertension
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Venous thrombosis limb
|
0.34%
1/298 • Number of events 1 • 12 months
Serious AE, Non-serious AE, All AE
|
Other adverse events
| Measure |
Next Generation Neuroform Stent System
n=298 participants at risk
The Next Generation Stent System is a self-expanding, open cell, nitinol stent designed to provide support of the coil mass within the aneurysm and minimize stent deflection.
Next Generation Neuroform Stent System: The Next Generation Neuroform Stent System is pre-loaded on a stent delivery wire and protected by a transfer sheath. An accessory pouch containing an optional stabilizer may be attached to the proximal end of the stent delivery wire to facilitate handling and stabilization.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
5/298 • Number of events 5 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
2.3%
7/298 • Number of events 7 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Cardiac disorders
Arrhythmia, tachycardia, afib or bradycardia
|
2.3%
7/298 • Number of events 7 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Ear and labyrinth disorders
Ear pain
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Eye disorders
Photophobia
|
2.0%
6/298 • Number of events 6 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Eye disorders
Blurred vision, diplopia, vision impairment or reduced acuity
|
5.0%
15/298 • Number of events 15 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Eye disorders
Vitreous floaters
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
5/298 • Number of events 5 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Abdominal pain or discomfort
|
2.7%
8/298 • Number of events 8 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Gastrointestinal disorders
Nausea or vomiting
|
5.4%
16/298 • Number of events 18 • 12 months
Serious AE, Non-serious AE, All AE
|
|
General disorders
Application site injury
|
6.4%
19/298 • Number of events 19 • 12 months
Serious AE, Non-serious AE, All AE
|
|
General disorders
Fatigue
|
1.7%
5/298 • Number of events 5 • 12 months
Serious AE, Non-serious AE, All AE
|
|
General disorders
Chest pain
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
General disorders
Asthenia
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
General disorders
Any pain
|
2.3%
7/298 • Number of events 8 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Infections and infestations
Infection
|
12.4%
37/298 • Number of events 47 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Infections and infestations
Urinary tract infection
|
6.0%
18/298 • Number of events 18 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Infections and infestations
Respiratory tract infection
|
2.3%
7/298 • Number of events 8 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Infections and infestations
Pneumonia
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Musculoskeletal and connective tissue disorders
Fall
|
2.3%
7/298 • Number of events 8 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.7%
8/298 • Number of events 9 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.3%
4/298 • Number of events 4 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
8/298 • Number of events 8 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
7/298 • Number of events 7 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal pain
|
4.4%
13/298 • Number of events 13 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Cerebral vasoconstriction
|
8.7%
26/298 • Number of events 27 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Dizziness
|
5.7%
17/298 • Number of events 17 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Convulsion
|
1.3%
4/298 • Number of events 4 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Headache
|
24.2%
72/298 • Number of events 85 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Vertebral artery dissection
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Hypoaesthesia
|
3.4%
10/298 • Number of events 14 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Transient ischemic attack
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Nervous system disorders
Hemiparesis
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
9/298 • Number of events 9 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
6/298 • Number of events 6 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Hypertension
|
1.3%
4/298 • Number of events 4 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Hypotension
|
2.0%
6/298 • Number of events 7 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Contusion
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
|
Vascular disorders
Thrombosis in device
|
1.0%
3/298 • Number of events 3 • 12 months
Serious AE, Non-serious AE, All AE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER