Trial Outcomes & Findings for ViVEXX Carotid Revascularization Trial (VIVA) (NCT NCT00417963)
NCT ID: NCT00417963
Last Updated: 2017-03-01
Results Overview
A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
407 participants
Primary outcome timeframe
365 days from implantation
Results posted on
2017-03-01
Participant Flow
Enrollment commenced on October 7, 2005 and was completed on November 6, 2007. A total of 486 patients from 34 investigative sites within the United States were enrolled, including 79 in the roll-in cohort and 407 in the pivotal cohort. The Roll-in cohort is intended to provide initial training and verification of procedure technique
Each site was required to enroll at least one roll-in patient prior to commencing the pivotal phase to demonstrate appropriate training and technique. Each roll-in patient was required to meet the same eligibility criteria and follow the same follow-up schedule as the pivotal cohort. The pivotal cohort represents the intent-to-treat population.
Participant milestones
| Measure |
ViVexx Carotid Stent Group
placement of a bare metal stent for treatment of carotid artery stenosis
|
|---|---|
|
Overall Study
STARTED
|
486
|
|
Overall Study
COMPLETED
|
445
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
ViVexx Carotid Stent Group
placement of a bare metal stent for treatment of carotid artery stenosis
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Death
|
17
|
|
Overall Study
Study device could not be deployed
|
3
|
Baseline Characteristics
ViVEXX Carotid Revascularization Trial (VIVA)
Baseline characteristics by cohort
| Measure |
ViVexx Carotid Stent Group
n=486 Participants
placement of a bare metal stent for treatment of carotid artery stenosis
|
|---|---|
|
Age, Continuous
|
72.1 years
STANDARD_DEVIATION 9.14 • n=5 Participants
|
|
Gender
Female
|
191 Participants
n=5 Participants
|
|
Gender
Male
|
295 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
486 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 365 days from implantationPopulation: All patients who were enrolled in the pivotal cohort were analyzed as an intention to treat population.
A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure.
Outcome measures
| Measure |
ViVexx Carotid Stent Group
n=486 Participants
placement of a bare metal stent for treatment of carotid artery stenosis
|
Roll-in Cohort
Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
|
Pivotal Cohort
Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
|
|---|---|---|---|
|
Percentage of Patients Experiencing Major Adverse Events (MAE)
|
6.9 percentage of participants
Interval 4.5 to 9.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months from implantationPopulation: Number of participants experiencing target lesion revascularization up to 12 months from implantation
Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation
Outcome measures
| Measure |
ViVexx Carotid Stent Group
n=486 Participants
placement of a bare metal stent for treatment of carotid artery stenosis
|
Roll-in Cohort
n=79 Participants
Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
|
Pivotal Cohort
n=407 Participants
Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
|
|---|---|---|---|
|
Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)
|
19 Number of participants
|
2 Number of participants
|
17 Number of participants
|
SECONDARY outcome
Timeframe: 30 days following implantationPopulation: Number of participants experiencing access site complications requiring blood transfusion (\>1 unit) or open repair.
Access site complications requiring blood transfusion (\> 1 unit) or open surgical repair.
Outcome measures
| Measure |
ViVexx Carotid Stent Group
n=486 Participants
placement of a bare metal stent for treatment of carotid artery stenosis
|
Roll-in Cohort
n=79 Participants
Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
|
Pivotal Cohort
n=407 Participants
Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
|
|---|---|---|---|
|
Number of Patients Experiencing Access Site Complications
|
8 Number of participants
|
1 Number of participants
|
7 Number of participants
|
SECONDARY outcome
Timeframe: 30 days from implantationPopulation: Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to index procedure.
Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure.
Outcome measures
| Measure |
ViVexx Carotid Stent Group
n=486 Participants
placement of a bare metal stent for treatment of carotid artery stenosis
|
Roll-in Cohort
n=79 Participants
Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
|
Pivotal Cohort
n=407 Participants
Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
|
|---|---|---|---|
|
Number of Participants Experiencing Stroke Related Neurologic Deficit
|
11 number of participants
|
1 number of participants
|
10 number of participants
|
SECONDARY outcome
Timeframe: at time of implantationPopulation: Number of participants with successful delivery and deployment of device with \<50% residual stenosis.
Number of participants with successful delivery and deployment of device with \<50% residual stenosis.
Outcome measures
| Measure |
ViVexx Carotid Stent Group
n=486 Participants
placement of a bare metal stent for treatment of carotid artery stenosis
|
Roll-in Cohort
Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
|
Pivotal Cohort
Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
|
|---|---|---|---|
|
Number of Participants Experiencing Device Success
Vivexx stent success
|
462 number of participants
|
—
|
—
|
|
Number of Participants Experiencing Device Success
Emboshield device success
|
462 number of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: at time of implantationPopulation: number of participants with lesion success defined as \<50% residual stenosis.
number of participants experiencing achievement of \<50% final residual diameter stenosis in the stented segment using the VIVEXX Carotid Stent and the Emboshield Embolic Protection System.
Outcome measures
| Measure |
ViVexx Carotid Stent Group
n=486 Participants
placement of a bare metal stent for treatment of carotid artery stenosis
|
Roll-in Cohort
Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
|
Pivotal Cohort
Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
|
|---|---|---|---|
|
Number of Participants Experiencing Lesion Success
|
473 number of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months after implantationPopulation: Number of participants experiencing restenosis through 12 months from implantation.
Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.
Outcome measures
| Measure |
ViVexx Carotid Stent Group
n=431 Participants
placement of a bare metal stent for treatment of carotid artery stenosis
|
Roll-in Cohort
n=366 Participants
Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
|
Pivotal Cohort
Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
|
|---|---|---|---|
|
Number of Participants Experiencing Restenosis
|
68 number of participants
|
43 number of participants
|
—
|
Adverse Events
ViVexx Carotid Stent Group
Serious events: 316 serious events
Other events: 301 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ViVexx Carotid Stent Group
n=486 participants at risk
placement of a bare metal stent for treatment of carotid artery stenosis
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.3%
21/486 • Implantation through 12 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.41%
2/486 • Implantation through 12 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.62%
3/486 • Implantation through 12 months
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.21%
1/486 • Implantation through 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.21%
1/486 • Implantation through 12 months
|
|
Cardiac disorders
Angina pectoris
|
0.82%
4/486 • Implantation through 12 months
|
|
Cardiac disorders
Angia unstable
|
0.21%
1/486 • Implantation through 12 months
|
|
Cardiac disorders
Aortic valve stenosis
|
0.21%
1/486 • Implantation through 12 months
|
|
Cardiac disorders
Arrythmia
|
0.82%
4/486 • Implantation through 12 months
|
|
Cardiac disorders
Atrial Figrillation
|
3.1%
15/486 • Implantation through 12 months
|
|
Cardiac disorders
Arterioventricular block first degree
|
0.21%
1/486 • Implantation through 12 months
|
|
Cardiac disorders
Bradycardia
|
2.5%
12/486 • Implantation through 12 months
|
|
Cardiac disorders
Bundle branch block right
|
0.21%
1/486 • Implantation through 12 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.62%
3/486 • Implantation through 12 months
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
8/486 • Implantation through 12 months
|
|
Cardiac disorders
Cardiomegaly
|
0.21%
1/486 • Implantation through 12 months
|
|
Cardiac disorders
Coronary artery disease
|
0.21%
1/486 • Implantation through 12 months
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
8/486 • Implantation through 12 months
|
|
Cardiac disorders
Palpitations
|
0.21%
1/486 • Implantation through 12 months
|
|
Cardiac disorders
Sinus bradycardia
|
1.2%
6/486 • Implantation through 12 months
|
|
Cardiac disorders
Tachycardia
|
0.21%
1/486 • Implantation through 12 months
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.41%
2/486 • Implantation through 12 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.82%
4/486 • Implantation through 12 months
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.21%
1/486 • Implantation through 12 months
|
|
Congenital, familial and genetic disorders
Congenital arterial malformation
|
0.21%
1/486 • Implantation through 12 months
|
|
Ear and labyrinth disorders
Deafness
|
0.41%
2/486 • Implantation through 12 months
|
|
Ear and labyrinth disorders
Ear Pain
|
0.82%
4/486 • Implantation through 12 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.21%
1/486 • Implantation through 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.62%
3/486 • Implantation through 12 months
|
|
Eye disorders
Amaurosis fugax
|
0.21%
1/486 • Implantation through 12 months
|
|
Eye disorders
Conjunctival heamorrhage
|
0.21%
1/486 • Implantation through 12 months
|
|
Eye disorders
Eye Pain
|
0.21%
1/486 • Implantation through 12 months
|
|
Eye disorders
Gaze palsy
|
0.41%
2/486 • Implantation through 12 months
|
|
Eye disorders
Halo vision
|
0.21%
1/486 • Implantation through 12 months
|
|
Eye disorders
Macular degeneration
|
0.41%
2/486 • Implantation through 12 months
|
|
Eye disorders
Orbital oedema
|
0.21%
1/486 • Implantation through 12 months
|
|
Eye disorders
Retinal artery embolism
|
0.21%
1/486 • Implantation through 12 months
|
|
Eye disorders
Rtinal vein occlusion
|
0.21%
1/486 • Implantation through 12 months
|
|
Eye disorders
Vision blurred
|
0.21%
1/486 • Implantation through 12 months
|
|
Eye disorders
Visual acuity reduced
|
0.21%
1/486 • Implantation through 12 months
|
|
Eye disorders
Visual impairment
|
0.21%
1/486 • Implantation through 12 months
|
|
Endocrine disorders
Hypothyrodism
|
0.82%
4/486 • Implantation through 12 months
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.82%
4/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Colonic polyp
|
0.62%
3/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
onstipation
|
1.4%
7/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Dental caries
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
6/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.62%
3/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.62%
3/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Nausea
|
1.4%
7/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Oral disorder
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Tooth impacted
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Toothache
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
1/486 • Implantation through 12 months
|
|
General disorders
Adverse drug reaction
|
0.82%
4/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.21%
1/486 • Implantation through 12 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.21%
1/486 • Implantation through 12 months
|
|
General disorders
Asthenia
|
0.21%
1/486 • Implantation through 12 months
|
|
General disorders
Catheter site haemorrhage
|
0.21%
1/486 • Implantation through 12 months
|
|
General disorders
Chest discomfort
|
0.41%
2/486 • Implantation through 12 months
|
|
General disorders
chest pain
|
2.5%
12/486 • Implantation through 12 months
|
|
General disorders
fatigue
|
0.62%
3/486 • Implantation through 12 months
|
|
General disorders
Gait disturbance
|
0.21%
1/486 • Implantation through 12 months
|
|
General disorders
Implant site erosion
|
0.21%
1/486 • Implantation through 12 months
|
|
General disorders
Infusion site extravasation
|
0.21%
1/486 • Implantation through 12 months
|
|
General disorders
Injection site haematoma
|
2.3%
11/486 • Implantation through 12 months
|
|
General disorders
Injection site haemorrhage
|
0.21%
1/486 • Implantation through 12 months
|
|
General disorders
Injection site pain
|
0.21%
1/486 • Implantation through 12 months
|
|
General disorders
mass
|
0.21%
1/486 • Implantation through 12 months
|
|
General disorders
Non-cardiac chest pain
|
0.41%
2/486 • Implantation through 12 months
|
|
General disorders
Oedema peripheral
|
2.1%
10/486 • Implantation through 12 months
|
|
General disorders
Pyrexia
|
1.0%
5/486 • Implantation through 12 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.21%
1/486 • Implantation through 12 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.62%
3/486 • Implantation through 12 months
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.21%
1/486 • Implantation through 12 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.41%
2/486 • Implantation through 12 months
|
|
Infections and infestations
Acute sinusitis
|
0.21%
1/486 • Implantation through 12 months
|
|
Infections and infestations
Adenoviral upper respitaory infections
|
0.21%
1/486 • Implantation through 12 months
|
|
Infections and infestations
Bacterial disease carrier
|
0.21%
1/486 • Implantation through 12 months
|
|
Infections and infestations
Bronchitis
|
0.82%
4/486 • Implantation through 12 months
|
|
Infections and infestations
Cellulitis
|
0.62%
3/486 • Implantation through 12 months
|
|
Infections and infestations
Clostridial infection
|
0.21%
1/486 • Implantation through 12 months
|
|
Infections and infestations
Clostridium defficile colitis
|
0.21%
1/486 • Implantation through 12 months
|
|
Infections and infestations
Eye infection
|
0.21%
1/486 • Implantation through 12 months
|
|
Infections and infestations
Herpes zoster
|
0.62%
3/486 • Implantation through 12 months
|
|
Infections and infestations
Infection
|
0.41%
2/486 • Implantation through 12 months
|
|
Infections and infestations
Labyrinthitis
|
0.21%
1/486 • Implantation through 12 months
|
|
Infections and infestations
Otitis externa
|
0.41%
2/486 • Implantation through 12 months
|
|
Infections and infestations
Pneumonia
|
2.1%
10/486 • Implantation through 12 months
|
|
Infections and infestations
Sinusitis
|
0.62%
3/486 • Implantation through 12 months
|
|
Infections and infestations
Skin Candida
|
0.21%
1/486 • Implantation through 12 months
|
|
Infections and infestations
Tooth infection
|
0.21%
1/486 • Implantation through 12 months
|
|
Infections and infestations
Tracheobronchitis
|
0.21%
1/486 • Implantation through 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.62%
3/486 • Implantation through 12 months
|
|
Infections and infestations
Urinary tract infection
|
2.9%
14/486 • Implantation through 12 months
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.21%
1/486 • Implantation through 12 months
|
|
Infections and infestations
Viral infection
|
0.21%
1/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.21%
1/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.21%
1/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.21%
1/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
fall
|
0.82%
4/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.21%
1/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.21%
1/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.21%
1/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.21%
1/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.62%
3/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.21%
1/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.21%
1/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.41%
2/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Wound
|
0.21%
1/486 • Implantation through 12 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.21%
1/486 • Implantation through 12 months
|
|
Investigations
Blood creatine phospokinase MB increased
|
0.21%
1/486 • Implantation through 12 months
|
|
Investigations
Blood magnesium decreased
|
0.21%
1/486 • Implantation through 12 months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.21%
1/486 • Implantation through 12 months
|
|
Investigations
Full blood count decreased
|
0.21%
1/486 • Implantation through 12 months
|
|
Investigations
Haemoglobin decreased
|
1.2%
6/486 • Implantation through 12 months
|
|
Investigations
Heart rate decreased
|
0.21%
1/486 • Implantation through 12 months
|
|
Investigations
Heart rate irregular
|
0.21%
1/486 • Implantation through 12 months
|
|
Investigations
NIH stroke scale abnormal
|
0.21%
1/486 • Implantation through 12 months
|
|
Investigations
Neurological examination abnormal
|
0.21%
1/486 • Implantation through 12 months
|
|
Investigations
Troponin
|
0.21%
1/486 • Implantation through 12 months
|
|
Investigations
Troponin increased
|
0.21%
1/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
1/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.62%
3/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Gout
|
0.41%
2/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.41%
2/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.62%
3/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.21%
1/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.41%
2/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.62%
3/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.21%
1/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.62%
3/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.21%
1/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.21%
1/486 • Implantation through 12 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.21%
1/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.62%
3/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.41%
2/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.2%
6/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.21%
1/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.21%
1/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.0%
5/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.82%
4/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.21%
1/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.21%
1/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculskeletal pain
|
0.62%
3/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.41%
2/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.0%
5/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.41%
2/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.21%
1/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
6/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.21%
1/486 • Implantation through 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.62%
3/486 • Implantation through 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.21%
1/486 • Implantation through 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.21%
1/486 • Implantation through 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.21%
1/486 • Implantation through 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.21%
1/486 • Implantation through 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Aphasia
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Areflexia
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Ataxia
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Basilar artery stenosis
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Burning sensation
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Carotid ARtery Stenosis
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.41%
2/486 • Implantation through 12 months
|
|
Nervous system disorders
Cerebral ischaemia
|
1.6%
8/486 • Implantation through 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
5/486 • Implantation through 12 months
|
|
Nervous system disorders
cognitive disorder
|
0.82%
4/486 • Implantation through 12 months
|
|
Nervous system disorders
convulsion
|
0.82%
4/486 • Implantation through 12 months
|
|
Nervous system disorders
Diabetic neuropathy
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Dizziness
|
4.5%
22/486 • Implantation through 12 months
|
|
Nervous system disorders
Dysarthria
|
0.41%
2/486 • Implantation through 12 months
|
|
Nervous system disorders
Embolic stroke
|
0.41%
2/486 • Implantation through 12 months
|
|
Nervous system disorders
Facial paresis
|
0.41%
2/486 • Implantation through 12 months
|
|
Nervous system disorders
Headache
|
2.9%
14/486 • Implantation through 12 months
|
|
Nervous system disorders
Hemianopia
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Hypoaesthesia
|
1.0%
5/486 • Implantation through 12 months
|
|
Nervous system disorders
Intracranial haematoma
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Loss of consciousness
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Momory impairment
|
0.41%
2/486 • Implantation through 12 months
|
|
Nervous system disorders
Motor dysfunction
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Nerve compression
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.41%
2/486 • Implantation through 12 months
|
|
Nervous system disorders
Parkinson's disease
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Presyncope
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Sensory loss
|
0.41%
2/486 • Implantation through 12 months
|
|
Nervous system disorders
Paraesthesia
|
0.82%
4/486 • Implantation through 12 months
|
|
Nervous system disorders
Speech disorder
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Syncope
|
1.4%
7/486 • Implantation through 12 months
|
|
Nervous system disorders
Syncope vasovagal
|
0.41%
2/486 • Implantation through 12 months
|
|
Nervous system disorders
Unresponsive to stimui
|
0.21%
1/486 • Implantation through 12 months
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.21%
1/486 • Implantation through 12 months
|
|
Psychiatric disorders
Agitation
|
0.21%
1/486 • Implantation through 12 months
|
|
Psychiatric disorders
Anxiety
|
0.82%
4/486 • Implantation through 12 months
|
|
Psychiatric disorders
Confusional state
|
0.62%
3/486 • Implantation through 12 months
|
|
Psychiatric disorders
Depression
|
0.21%
1/486 • Implantation through 12 months
|
|
Psychiatric disorders
Insomnia
|
0.82%
4/486 • Implantation through 12 months
|
|
Psychiatric disorders
Mental status changes
|
0.21%
1/486 • Implantation through 12 months
|
|
Renal and urinary disorders
Azotaemia
|
0.21%
1/486 • Implantation through 12 months
|
|
Renal and urinary disorders
Bladder distension
|
0.21%
1/486 • Implantation through 12 months
|
|
Renal and urinary disorders
Dysuria
|
0.21%
1/486 • Implantation through 12 months
|
|
Renal and urinary disorders
Haematuria
|
0.41%
2/486 • Implantation through 12 months
|
|
Renal and urinary disorders
Oliguria
|
0.21%
1/486 • Implantation through 12 months
|
|
Renal and urinary disorders
Renal cyst
|
0.21%
1/486 • Implantation through 12 months
|
|
Renal and urinary disorders
Renal failure
|
2.3%
11/486 • Implantation through 12 months
|
|
Renal and urinary disorders
Renal mass
|
0.21%
1/486 • Implantation through 12 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.21%
1/486 • Implantation through 12 months
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
5/486 • Implantation through 12 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.21%
1/486 • Implantation through 12 months
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.21%
1/486 • Implantation through 12 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.21%
1/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.21%
1/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.21%
1/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.21%
1/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.21%
1/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
7/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.21%
1/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.21%
1/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.21%
1/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.21%
1/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.41%
2/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.21%
1/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.21%
1/486 • Implantation through 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.41%
2/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.21%
1/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.21%
1/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.62%
3/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.62%
3/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.41%
2/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.21%
1/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.21%
1/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.21%
1/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.21%
1/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.21%
1/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
Aneurysm
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
Aortic aneurysm
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
arterial restenosis
|
0.41%
2/486 • Implantation through 12 months
|
|
Vascular disorders
Arterial spasm
|
1.9%
9/486 • Implantation through 12 months
|
|
Vascular disorders
Arterial stenosis
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
Arteriovenous fistula
|
0.41%
2/486 • Implantation through 12 months
|
|
Vascular disorders
Blood pressure fluctuation
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
Carotid artery dissection
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
Haematoma
|
0.41%
2/486 • Implantation through 12 months
|
|
Vascular disorders
Haemorrhage
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
Hypertension
|
4.3%
21/486 • Implantation through 12 months
|
|
Vascular disorders
Hypotension
|
8.8%
43/486 • Implantation through 12 months
|
|
Vascular disorders
Intermittent claudication
|
1.2%
6/486 • Implantation through 12 months
|
|
Vascular disorders
Ischaemia
|
0.21%
1/486 • Implantation through 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
Hypoaesthesia facial
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.62%
3/486 • Implantation through 12 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.41%
2/486 • Implantation through 12 months
|
|
Vascular disorders
Peripheral vascular disorder
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
Subclavian artery stenosis
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
Thrombophlebitis
|
0.21%
1/486 • Implantation through 12 months
|
|
Vascular disorders
Thrombosis
|
0.21%
1/486 • Implantation through 12 months
|
Other adverse events
| Measure |
ViVexx Carotid Stent Group
n=486 participants at risk
placement of a bare metal stent for treatment of carotid artery stenosis
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.5%
56/486 • Implantation through 12 months
|
|
Cardiac disorders
Angina pectoris
|
5.6%
27/486 • Implantation through 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.8%
28/486 • Implantation through 12 months
|
|
Cardiac disorders
Bradycardia
|
5.6%
27/486 • Implantation through 12 months
|
|
Cardiac disorders
CArdiac failure congestive
|
9.3%
45/486 • Implantation through 12 months
|
|
Cardiac disorders
Mycardial infarction
|
8.8%
43/486 • Implantation through 12 months
|
|
Infections and infestations
Pneumonia
|
8.4%
41/486 • Implantation through 12 months
|
|
Nervous system disorders
Cerebralvascular accident
|
7.4%
36/486 • Implantation through 12 months
|
|
Nervous system disorders
Dizziness
|
6.6%
32/486 • Implantation through 12 months
|
|
Renal and urinary disorders
Renal Failure
|
8.0%
39/486 • Implantation through 12 months
|
|
Vascular disorders
Hypertension
|
8.8%
43/486 • Implantation through 12 months
|
|
Vascular disorders
Hypotension
|
22.0%
107/486 • Implantation through 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60