Trial Outcomes & Findings for Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy (NCT NCT01445613)
NCT ID: NCT01445613
Last Updated: 2016-08-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1203 participants
Primary outcome timeframe
0 to 365 days
Results posted on
2016-08-12
Participant Flow
Enrollment for the CANOPY clinical trial started on October 11, 2011 and was completed on September 12, 2013. The enrollment goal (1200 subjects) was reached with a total of 1203 subjects enrolled at 97 clinical sites.
3/1203 subjects who received a non-study stent, were excluded from the analysis. A total of 1200 subjects were included in the primary analysis population (Full analysis set (FAS)).
Participant milestones
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
|---|---|
|
30-day Follow-up
STARTED
|
1200
|
|
30-day Follow-up
COMPLETED
|
1165
|
|
30-day Follow-up
NOT COMPLETED
|
35
|
|
1-year Follow-up
STARTED
|
1165
|
|
1-year Follow-up
COMPLETED
|
1088
|
|
1-year Follow-up
NOT COMPLETED
|
77
|
Reasons for withdrawal
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
|---|---|
|
30-day Follow-up
Withdrawal by Subject
|
6
|
|
30-day Follow-up
Physician Decision
|
3
|
|
30-day Follow-up
Missed visit
|
23
|
|
30-day Follow-up
Death
|
3
|
|
1-year Follow-up
Withdrawal by Subject
|
12
|
|
1-year Follow-up
Missed visit
|
29
|
|
1-year Follow-up
Lost to Follow-up
|
2
|
|
1-year Follow-up
Death
|
30
|
|
1-year Follow-up
Physician Decision
|
2
|
|
1-year Follow-up
Received a non-study stent
|
2
|
Baseline Characteristics
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
Baseline characteristics by cohort
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=1200 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
|---|---|
|
Age, Continuous
|
69.52 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
491 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
709 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African Heritage
|
69 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1083 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Refused to answer
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Information not available
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1200 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 365 daysPopulation: FAS population
Outcome measures
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=1200 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
Composite of Peri-procedural DS in the Asymptomatic Group
Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
|
|---|---|---|
|
Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days)
|
4.4 percentage of participants
Standard Error 0.60
|
—
|
PRIMARY outcome
Timeframe: 365 daysPopulation: FAS population
Outcome measures
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=1200 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
Composite of Peri-procedural DS in the Asymptomatic Group
Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
|
|---|---|---|
|
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days
|
95.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: FAS population. The number of participants analyzed includes subjects with data available at that time frame.
Outcome measures
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=1178 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
Composite of Peri-procedural DS in the Asymptomatic Group
Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
|
|---|---|---|
|
Death and All Stroke
|
3.4 percentage of participants
Interval 2.44 to 4.6
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS population
Outcome measures
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=335 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
Composite of Peri-procedural DS in the Asymptomatic Group
n=865 Participants
Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
|
|---|---|---|
|
Composite of Peri-procedural Death and Stroke by Symptomatic Status
|
5.8 percentage of participants
Interval 3.55 to 8.95
|
2.5 percentage of participants
Interval 1.53 to 3.74
|
SECONDARY outcome
Timeframe: 365 daysPopulation: FAS population
Outcome measures
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=335 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
Composite of Peri-procedural DS in the Asymptomatic Group
n=865 Participants
Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
|
|---|---|---|
|
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status
|
92.5 percentage of participants
|
96.8 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS population. The number of participants analyzed includes subjects with data available at that time frame.
Outcome measures
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=116 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
Composite of Peri-procedural DS in the Asymptomatic Group
n=1062 Participants
Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
|
|---|---|---|
|
Composite of Peri-procedural Death and Stroke by Age
|
3.4 percentage of participants
Interval 0.95 to 8.59
|
3.4 percentage of participants
Interval 2.39 to 4.66
|
SECONDARY outcome
Timeframe: 365 daysPopulation: FAS population
Outcome measures
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=118 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
Composite of Peri-procedural DS in the Asymptomatic Group
n=1082 Participants
Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
|
|---|---|---|
|
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age
|
93.8 percentage of participants
|
95.8 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS population
Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis \>50% in the stented lesion, or is asymptomatic and has a stenosis of \>80% in the stented lesion.
Outcome measures
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=1200 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
Composite of Peri-procedural DS in the Asymptomatic Group
Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
|
|---|---|---|
|
Freedom From Clinically Driven Target Lesion Revascularization
|
99.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 180 daysPopulation: FAS population
Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis \>50% in the stented lesion, or is asymptomatic and has a stenosis of \>80% in the stented lesion.
Outcome measures
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=1200 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
Composite of Peri-procedural DS in the Asymptomatic Group
Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
|
|---|---|---|
|
Freedom From Clinically Driven Target Lesion Revascularization
|
99.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 365 daysPopulation: FAS population
Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis \>50% in the stented lesion, or is asymptomatic and has a stenosis of \>80% in the stented lesion.
Outcome measures
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=1200 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
Composite of Peri-procedural DS in the Asymptomatic Group
Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
|
|---|---|---|
|
Freedom From Clinically Driven Target Lesion Revascularization
|
99.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS population
Clinical success is defined as the attainment of \< 50% residual stenosis of the target lesion and absence of a death or stroke 30-day post-procedure.
Outcome measures
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=1200 Participants
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
Composite of Peri-procedural DS in the Asymptomatic Group
Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
|
|---|---|---|
|
Clinical Success
|
96.4 percentage of participants
Interval 95.2 to 97.39
|
—
|
Adverse Events
RX Acculink Carotid Stent System (RX Acculink)
Serious events: 266 serious events
Other events: 619 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=1200 participants at risk
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
|---|---|
|
General disorders
Hematoma
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Infection At Insertion Site
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Other: under access site complication
|
0.08%
1/1200 • 365 Days
|
|
Immune system disorders
Allergic Reaction To Contrast
|
0.08%
1/1200 • 365 Days
|
|
Blood and lymphatic system disorders
GI Bleed
|
0.08%
1/1200 • 365 Days
|
|
Blood and lymphatic system disorders
Hematoma
|
0.08%
1/1200 • 365 Days
|
|
Blood and lymphatic system disorders
Anemia
|
0.58%
7/1200 • 365 Days
|
|
Blood and lymphatic system disorders
Bleeding
|
0.08%
1/1200 • 365 Days
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.08%
1/1200 • 365 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant
|
0.33%
4/1200 • 365 Days
|
|
Cardiac disorders
Abnormal Lab Test
|
0.08%
1/1200 • 365 Days
|
|
Cardiac disorders
Angina
|
0.50%
6/1200 • 365 Days
|
|
Cardiac disorders
Arrhythmia (Includes Brady And Tachy)
|
0.83%
10/1200 • 365 Days
|
|
Cardiac disorders
Coronary artery disease - Coronary stenosis
|
0.42%
5/1200 • 365 Days
|
|
Cardiac disorders
Cardiac Arrest
|
0.50%
6/1200 • 365 Days
|
|
Cardiac disorders
Congestive Heart Failure
|
0.50%
6/1200 • 365 Days
|
|
Cardiac disorders
Dyspnea
|
0.17%
2/1200 • 365 Days
|
|
Cardiac disorders
Hypertension
|
0.08%
1/1200 • 365 Days
|
|
Cardiac disorders
Hypotension
|
0.58%
7/1200 • 365 Days
|
|
Cardiac disorders
Myocardial Infarction - Non Q wave
|
0.25%
3/1200 • 365 Days
|
|
Cardiac disorders
Myocardial Infarction - Q wave
|
0.17%
2/1200 • 365 Days
|
|
Cardiac disorders
Myocardial Infarction - Unknown
|
0.25%
3/1200 • 365 Days
|
|
Cardiac disorders
Peripheral vascular disease
|
0.08%
1/1200 • 365 Days
|
|
Cardiac disorders
Pain
|
0.33%
4/1200 • 365 Days
|
|
Cardiac disorders
Surgery/Intervention Procedure
|
0.33%
4/1200 • 365 Days
|
|
Cardiac disorders
Syncope
|
0.17%
2/1200 • 365 Days
|
|
Cardiac disorders
Thrombosis
|
0.08%
1/1200 • 365 Days
|
|
Cardiac disorders
Other
|
0.08%
1/1200 • 365 Days
|
|
Gastrointestinal disorders
Bleeding
|
0.25%
3/1200 • 365 Days
|
|
Gastrointestinal disorders
Diverticulitis
|
0.08%
1/1200 • 365 Days
|
|
Gastrointestinal disorders
GI Bleed
|
0.08%
1/1200 • 365 Days
|
|
Gastrointestinal disorders
Vomiting
|
0.08%
1/1200 • 365 Days
|
|
Gastrointestinal disorders
Other
|
0.42%
5/1200 • 365 Days
|
|
Renal and urinary disorders
Hematuria
|
0.17%
2/1200 • 365 Days
|
|
Renal and urinary disorders
Kidney Damage Due To Other
|
0.17%
2/1200 • 365 Days
|
|
Renal and urinary disorders
Malignant
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Renal Artery Disease
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Renal Failure
|
0.25%
3/1200 • 365 Days
|
|
Renal and urinary disorders
Sepsis
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Surgery/Intervention Procedure
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Tumor
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Urinary Retension
|
0.17%
2/1200 • 365 Days
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.25%
3/1200 • 365 Days
|
|
Renal and urinary disorders
Other
|
0.08%
1/1200 • 365 Days
|
|
Infections and infestations
Sepsis
|
0.08%
1/1200 • 365 Days
|
|
Infections and infestations
Urinary Tract Infection
|
0.17%
2/1200 • 365 Days
|
|
Infections and infestations
Wound Complication Or Wound Infection
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Diabetes
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Sensory Deficit
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Surgery/Intervention Procedure
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Abnormal Lab Test
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Anxiety
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Claudication
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Depression
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Diarrhea
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Other: under miscellaneous category
|
0.58%
7/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.08%
1/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.25%
3/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Cellulitis
|
0.08%
1/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.17%
2/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Other
|
0.33%
4/1200 • 365 Days
|
|
Nervous system disorders
Bleeding
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Confusion
|
0.33%
4/1200 • 365 Days
|
|
Nervous system disorders
Delerium
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Headache
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Mental Status Change
|
0.25%
3/1200 • 365 Days
|
|
Nervous system disorders
Post Traumatic Hemorrage
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Seizure
|
0.25%
3/1200 • 365 Days
|
|
Nervous system disorders
Speech Disturbance
|
0.17%
2/1200 • 365 Days
|
|
Nervous system disorders
Syncope
|
0.42%
5/1200 • 365 Days
|
|
Nervous system disorders
Transient Ischemia Attack
|
1.0%
12/1200 • 365 Days
|
|
Nervous system disorders
Vasovagal
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Visual Disturbances
|
0.17%
2/1200 • 365 Days
|
|
Nervous system disorders
Other
|
0.17%
2/1200 • 365 Days
|
|
General disorders
Anemia
|
0.42%
5/1200 • 365 Days
|
|
General disorders
Arrhythmia (Includes Brady And Tachy)
|
1.5%
18/1200 • 365 Days
|
|
General disorders
Bleeding
|
0.17%
2/1200 • 365 Days
|
|
General disorders
Colitis
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Dissection
|
0.25%
3/1200 • 365 Days
|
|
General disorders
Embolism
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Headache
|
0.17%
2/1200 • 365 Days
|
|
General disorders
Hemiparesis
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Hypertension
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Hypotension
|
5.0%
60/1200 • 365 Days
|
|
General disorders
Incisional Pain
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Ischemia
|
0.08%
1/1200 • 365 Days
|
|
General disorders
No reflow
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Pain
|
0.17%
2/1200 • 365 Days
|
|
General disorders
Pain At Insertion Site
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Pseudoaneurysm
|
0.50%
6/1200 • 365 Days
|
|
General disorders
Pulmonary Edema
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Transient Ischemia Attack
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Vessel Trauma
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Viral, Bacterial And Fungal Infections
|
0.17%
2/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.08%
1/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.08%
1/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.67%
8/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.08%
1/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.50%
6/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident - Major Hemorrhagic Ispilateral
|
0.25%
3/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident - Major Hemorrhagic Non-Ispilateral
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident - Major Ischemic Ispilateral
|
0.67%
8/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident - Major Ischemic Non-Ispilateral
|
0.17%
2/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident - Minor Hemorrhagic Bilateral
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident - Minor Hemorrhagic Ispilateral
|
0.17%
2/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident - Minor Hemorrhagic Non-Ispilateral
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident - Minor Ischemic Bilateral
|
0.25%
3/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident - Minor Ischemic Ispilateral
|
1.9%
23/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident - Minor Ischemic Non-Ispilateral
|
0.25%
3/1200 • 365 Days
|
|
Vascular disorders
Aneurysm
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Claudication
|
0.42%
5/1200 • 365 Days
|
|
Vascular disorders
Deep vein thrombosis
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Occlusion
|
0.25%
3/1200 • 365 Days
|
|
Vascular disorders
Peripheral artery disease
|
0.25%
3/1200 • 365 Days
|
|
Vascular disorders
Peripheral vascular disease
|
0.25%
3/1200 • 365 Days
|
|
Vascular disorders
Restenosis
|
0.83%
10/1200 • 365 Days
|
|
Vascular disorders
Thrombosis
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Vascular
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Other
|
0.33%
4/1200 • 365 Days
|
Other adverse events
| Measure |
RX Acculink Carotid Stent System (RX Acculink)
n=1200 participants at risk
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|
|---|---|
|
General disorders
Arrhythmia (Includes Brady And Tachy)
|
8.9%
107/1200 • 365 Days
|
|
General disorders
Hypotension
|
20.2%
242/1200 • 365 Days
|
|
General disorders
Bleeding
|
0.83%
10/1200 • 365 Days
|
|
General disorders
Ecchymosis/Bruising
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Hematoma
|
1.6%
19/1200 • 365 Days
|
|
General disorders
Infection At Insertion Site
|
0.17%
2/1200 • 365 Days
|
|
General disorders
Pain
|
1.1%
13/1200 • 365 Days
|
|
General disorders
Pain At Insertion Site
|
0.50%
6/1200 • 365 Days
|
|
General disorders
Other
|
0.92%
11/1200 • 365 Days
|
|
Immune system disorders
Allergic Reaction To Contrast
|
0.33%
4/1200 • 365 Days
|
|
Immune system disorders
Rash
|
0.50%
6/1200 • 365 Days
|
|
Immune system disorders
Other
|
0.42%
5/1200 • 365 Days
|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
13/1200 • 365 Days
|
|
Blood and lymphatic system disorders
Bleeding
|
0.17%
2/1200 • 365 Days
|
|
Blood and lymphatic system disorders
Ecchymosis/Bruising
|
0.17%
2/1200 • 365 Days
|
|
Blood and lymphatic system disorders
GI Bleed
|
0.17%
2/1200 • 365 Days
|
|
Blood and lymphatic system disorders
Hematoma
|
0.58%
7/1200 • 365 Days
|
|
Blood and lymphatic system disorders
Abnormal Lab Test
|
0.08%
1/1200 • 365 Days
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.08%
1/1200 • 365 Days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.08%
1/1200 • 365 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant
|
0.33%
4/1200 • 365 Days
|
|
Cardiac disorders
Abnormal Lab Test
|
0.17%
2/1200 • 365 Days
|
|
Cardiac disorders
Angina
|
1.1%
13/1200 • 365 Days
|
|
Cardiac disorders
Arrhythmia (Includes Brady And Tachy)
|
3.5%
42/1200 • 365 Days
|
|
Cardiac disorders
Asystole
|
0.25%
3/1200 • 365 Days
|
|
Cardiac disorders
Atrial Fibrillation
|
0.08%
1/1200 • 365 Days
|
|
Cardiac disorders
CAD - Coronary stenosis
|
0.42%
5/1200 • 365 Days
|
|
Cardiac disorders
Cardiac Arrest
|
0.50%
6/1200 • 365 Days
|
|
Cardiac disorders
Congestive Heart Failure
|
0.67%
8/1200 • 365 Days
|
|
Cardiac disorders
Dizziness
|
0.08%
1/1200 • 365 Days
|
|
Cardiac disorders
Dyspnea
|
0.17%
2/1200 • 365 Days
|
|
Cardiac disorders
Hypertension
|
1.1%
13/1200 • 365 Days
|
|
Cardiac disorders
Hypotension
|
1.9%
23/1200 • 365 Days
|
|
Cardiac disorders
Ischemia
|
0.08%
1/1200 • 365 Days
|
|
Cardiac disorders
Myocardial Infarction - Non Q wave
|
0.25%
3/1200 • 365 Days
|
|
Cardiac disorders
Myocardial Infarction - Q wave
|
0.17%
2/1200 • 365 Days
|
|
Cardiac disorders
Myocardial Infarction - Unknown
|
0.25%
3/1200 • 365 Days
|
|
Cardiac disorders
Peripheral vascular disease (PVD)
|
0.08%
1/1200 • 365 Days
|
|
Cardiac disorders
Pain
|
0.67%
8/1200 • 365 Days
|
|
Cardiac disorders
Spasm
|
0.08%
1/1200 • 365 Days
|
|
Cardiac disorders
Surgery/Intervention Procedure
|
0.42%
5/1200 • 365 Days
|
|
Cardiac disorders
Syncope
|
0.17%
2/1200 • 365 Days
|
|
Cardiac disorders
Thrombosis
|
0.08%
1/1200 • 365 Days
|
|
Cardiac disorders
Vasovagal
|
0.08%
1/1200 • 365 Days
|
|
Cardiac disorders
Other
|
0.08%
1/1200 • 365 Days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.25%
3/1200 • 365 Days
|
|
Gastrointestinal disorders
Bleeding
|
0.25%
3/1200 • 365 Days
|
|
Gastrointestinal disorders
Constipation
|
0.08%
1/1200 • 365 Days
|
|
Gastrointestinal disorders
Diarrhea
|
0.08%
1/1200 • 365 Days
|
|
Gastrointestinal disorders
Diverticulitis
|
0.08%
1/1200 • 365 Days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease (GERD)
|
0.08%
1/1200 • 365 Days
|
|
Gastrointestinal disorders
Gastrointestinal (GI) bleed
|
0.08%
1/1200 • 365 Days
|
|
Gastrointestinal disorders
Nausea
|
0.25%
3/1200 • 365 Days
|
|
Gastrointestinal disorders
Pain
|
0.08%
1/1200 • 365 Days
|
|
Gastrointestinal disorders
Vomiting
|
0.17%
2/1200 • 365 Days
|
|
Gastrointestinal disorders
Other
|
0.50%
6/1200 • 365 Days
|
|
Renal and urinary disorders
Abnormal Lab Test
|
0.17%
2/1200 • 365 Days
|
|
Renal and urinary disorders
Dysuria
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Hematuria
|
0.25%
3/1200 • 365 Days
|
|
Renal and urinary disorders
Incontinence
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Kidney Damage Due To Other
|
0.17%
2/1200 • 365 Days
|
|
Renal and urinary disorders
Malignant
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Renal Artery Disease
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Renal Failure
|
0.25%
3/1200 • 365 Days
|
|
Renal and urinary disorders
Sepsis
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Surgery/Intervention Procedure
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Tumor
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Urinary Retension
|
0.42%
5/1200 • 365 Days
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.50%
6/1200 • 365 Days
|
|
Renal and urinary disorders
Viral, Bacterial And Fungal Infections
|
0.08%
1/1200 • 365 Days
|
|
Renal and urinary disorders
Other
|
0.08%
1/1200 • 365 Days
|
|
Infections and infestations
Cellulitis
|
0.17%
2/1200 • 365 Days
|
|
Infections and infestations
Eye
|
0.08%
1/1200 • 365 Days
|
|
Infections and infestations
Sepsis
|
0.08%
1/1200 • 365 Days
|
|
Infections and infestations
Urinary Tract Infection
|
0.25%
3/1200 • 365 Days
|
|
Infections and infestations
Viral, Bacterial And Fungal Infections
|
0.25%
3/1200 • 365 Days
|
|
Infections and infestations
Wound Complication Or Wound Infection
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Abnormal Lab Test
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Diabetes
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Joint pain
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Sensory Deficit
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Surgery/Intervention Procedure
|
0.08%
1/1200 • 365 Days
|
|
Metabolism and nutrition disorders
Other
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Abnormal Lab Test
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Anxiety
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Back Pain
|
0.25%
3/1200 • 365 Days
|
|
General disorders
Claudication
|
0.17%
2/1200 • 365 Days
|
|
General disorders
Cough
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Depression
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Diarrhea
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Dizziness
|
0.33%
4/1200 • 365 Days
|
|
General disorders
Edema (Non Pulmonary)
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Headache
|
1.7%
20/1200 • 365 Days
|
|
General disorders
Joint pain
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Nausea
|
1.5%
18/1200 • 365 Days
|
|
General disorders
Rash
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Vomiting
|
0.25%
3/1200 • 365 Days
|
|
General disorders
Weakness
|
0.17%
2/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
1/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.08%
1/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.42%
5/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Cellulitis
|
0.08%
1/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Headache
|
0.17%
2/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Hematoma
|
0.08%
1/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.17%
2/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.50%
6/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
0.17%
2/1200 • 365 Days
|
|
Musculoskeletal and connective tissue disorders
Other
|
0.42%
5/1200 • 365 Days
|
|
Nervous system disorders
Bleeding
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Confusion
|
0.58%
7/1200 • 365 Days
|
|
Nervous system disorders
Delerium
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Dizziness
|
0.83%
10/1200 • 365 Days
|
|
Nervous system disorders
Headache
|
0.75%
9/1200 • 365 Days
|
|
Nervous system disorders
Mental Status Change
|
0.50%
6/1200 • 365 Days
|
|
Nervous system disorders
Nausea
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Neuralgia
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Neuropathy
|
0.17%
2/1200 • 365 Days
|
|
Nervous system disorders
Numbness
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Paralysis
|
0.17%
2/1200 • 365 Days
|
|
Nervous system disorders
Post Traumatic Hemorrage
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Seizure
|
0.42%
5/1200 • 365 Days
|
|
Nervous system disorders
Sensory Deficit
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Speech Disturbance
|
0.58%
7/1200 • 365 Days
|
|
Nervous system disorders
Syncope
|
0.83%
10/1200 • 365 Days
|
|
Nervous system disorders
Transient Ischemia Attack
|
1.8%
21/1200 • 365 Days
|
|
Nervous system disorders
Vasovagal
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Visual Disturbances
|
1.1%
13/1200 • 365 Days
|
|
Nervous system disorders
Weakness
|
0.08%
1/1200 • 365 Days
|
|
Nervous system disorders
Other
|
1.4%
17/1200 • 365 Days
|
|
General disorders
Access site event
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Allergic Reaction To Contrast
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Anemia
|
1.2%
15/1200 • 365 Days
|
|
General disorders
Asystole
|
0.33%
4/1200 • 365 Days
|
|
General disorders
Colitis
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Dissection
|
0.42%
5/1200 • 365 Days
|
|
General disorders
Embolism
|
0.17%
2/1200 • 365 Days
|
|
General disorders
Eye
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Hemiparesis
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Hemorrhage
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Hypertension
|
1.9%
23/1200 • 365 Days
|
|
General disorders
Incisional Pain
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Incontinence
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Ischemia
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Jaw Pain
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Mental Status Change
|
0.17%
2/1200 • 365 Days
|
|
General disorders
Neuralgia
|
0.08%
1/1200 • 365 Days
|
|
General disorders
No reflow
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Oozing
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Paralysis
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Pseudoaneurysm
|
0.67%
8/1200 • 365 Days
|
|
General disorders
Pulmonary Edema
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Renal Insufficiency
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Spasm
|
0.33%
4/1200 • 365 Days
|
|
General disorders
Speech Disturbance
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Syncope
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Thrombosis
|
0.17%
2/1200 • 365 Days
|
|
General disorders
Transient Ischemia Attack
|
0.25%
3/1200 • 365 Days
|
|
General disorders
Urinary Retension
|
0.17%
2/1200 • 365 Days
|
|
General disorders
Vasospasm
|
0.33%
4/1200 • 365 Days
|
|
General disorders
Vasovagal
|
0.25%
3/1200 • 365 Days
|
|
General disorders
Vessel Trauma
|
0.08%
1/1200 • 365 Days
|
|
General disorders
Viral, Bacterial And Fungal Infections
|
0.17%
2/1200 • 365 Days
|
|
General disorders
Visual Disturbances
|
0.33%
4/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.17%
2/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.08%
1/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.33%
4/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.08%
1/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.75%
9/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.17%
2/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.50%
6/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Viral, Bacterial And Fungal Infections
|
0.08%
1/1200 • 365 Days
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident (CVA) - Major Hemorrhagic Ispilateral
|
0.25%
3/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident (CVA)-Major Hemorrhagic Non-Ispilateral
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident (CVA) - Major Ischemic Ispilateral
|
0.67%
8/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident (CVA) - Major Ischemic Non-Ispilateral
|
0.17%
2/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident (CVA) - Minor Hemorrhagic Bilateral
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident (CVA) - Minor Hemorrhagic Ispilateral
|
0.17%
2/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident (CVA) - Minor Hemorrhagic Non-Ispilateral
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident (CVA) - Minor Ischemic Bilateral
|
0.25%
3/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident (CVA) - Minor Ischemic Ispilateral
|
2.1%
25/1200 • 365 Days
|
|
Vascular disorders
Cerebrovascular accident (CVA) - Minor Ischemic Non-Ispilateral
|
0.33%
4/1200 • 365 Days
|
|
Vascular disorders
Aneurysm
|
0.25%
3/1200 • 365 Days
|
|
Vascular disorders
Arrhythmia (Includes Brady And Tachy)
|
0.17%
2/1200 • 365 Days
|
|
Vascular disorders
Claudication
|
0.50%
6/1200 • 365 Days
|
|
Vascular disorders
Deep venous thrombosis (DVT)
|
0.17%
2/1200 • 365 Days
|
|
Vascular disorders
Dissection
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Occlusion
|
0.33%
4/1200 • 365 Days
|
|
Vascular disorders
Peripheral artery disease (PAD)
|
0.25%
3/1200 • 365 Days
|
|
Vascular disorders
Peripheral vascular disease (PVD)
|
0.33%
4/1200 • 365 Days
|
|
Vascular disorders
Restenosis
|
0.83%
10/1200 • 365 Days
|
|
Vascular disorders
Spasm
|
0.17%
2/1200 • 365 Days
|
|
Vascular disorders
Surgery/Intervention Procedure
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Syncope
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Thrombosis
|
0.17%
2/1200 • 365 Days
|
|
Vascular disorders
Vascular
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Vasospasm
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Vasovagal
|
0.08%
1/1200 • 365 Days
|
|
Vascular disorders
Other
|
0.33%
4/1200 • 365 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60