CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01445613
• Collaborator: (none)
• Enrollment: 1,203
• Location: 1
• Arm: 1
• Duration (Months): 53
• Patients Per Site Per Month: 22.7

Study Details

Study Description

Brief Summary

The objective of the CANOPY trial is to assess the continued safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in subjects at standard risk for adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of carotid stenting experience.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Disease; Stroke; Amaurosis Fugax; Transient Ischemic Attack (TIA)	Device: RX Acculink Carotid Stent System (RX Acculink)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1203 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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) [0 to 365 days]

2. Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days [365 days]

Secondary Outcome Measures

1. Death and All Stroke [30 Days]

2. Composite of Peri-procedural Death and Stroke by Symptomatic Status [30 days]

3. Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status [365 days]

4. Composite of Peri-procedural Death and Stroke by Age [30 days]

5. Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age [365 days]

6. Freedom From Clinically Driven Target Lesion Revascularization [30 days]

   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.

7. Freedom From Clinically Driven Target Lesion Revascularization [180 days]

   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.

8. Freedom From Clinically Driven Target Lesion Revascularization [365 days]

   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.

9. Clinical Success [30 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject must be ≥ 18 years of age.

2. Subject does not have any condition that limits their anticipated survival to less than 3 years.

3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure.

4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR-

5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram.

6. Subject with all the following target vessel characteristics:

7. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).

8. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery.

9. Absence of excessive vessel tortuosity that would impede delivery of devices.

10. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure.

Exclusion Criteria:

1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA).

2. Subject with Hgb <10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) > 1.5.

3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions.

4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such.

5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abbott Vascular	Santa Clara	California	United States	95054

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: D. Christopher Metzger, MD, Wellmont Holston Valley Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01445613
• Other Study ID Numbers: 10-720
• First Posted: Oct 4, 2011
• Last Update Posted: Aug 12, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Abbott Medical Devices: Carotid; Stent; Carotid Endarterectomy
• Additional relevant MeSH terms: Ischemic Attack, Transient; Carotid Artery Diseases; Blindness; Amaurosis Fugax

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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)).

Arm/Group Title	RX Acculink Carotid Stent System (RX Acculink)
Arm/Group Description	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.
Period Title: 30-day Follow-up
STARTED	1200
COMPLETED	1165
NOT COMPLETED	35
Period Title: 30-day Follow-up
STARTED	1165
COMPLETED	1088
NOT COMPLETED	77

Baseline Characteristics

Arm/Group Title	RX Acculink Carotid Stent System (RX Acculink)
Arm/Group Description	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.
Overall Participants	1200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.52 (8.46)
Sex: Female, Male (Count of Participants)
Female	491 40.9%
Male	709 59.1%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	10 0.8%
Asian	14 1.2%
Black or African Heritage	69 5.8%
Native Hawaiian or other Pacific Islander	1 0.1%
White	1083 90.3%
Hispanic or Latino	30 2.5%
Refused to answer	3 0.3%
Information not available	3 0.3%
Region of Enrollment (participants) [Number]
United States	1200 100%

Outcome Measures

1. Primary Outcome

Title	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)
Time Frame	0 to 365 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	RX Acculink Carotid Stent System (RX Acculink)
Arm/Group Description	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.
Measure Participants	1200
Mean (Standard Error) [percentage of participants]	4.4 (0.60) 0.4%

2. Secondary Outcome

Title	Death and All Stroke
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

FAS population. The number of participants analyzed includes subjects with data available at that time frame.

Arm/Group Title	RX Acculink Carotid Stent System (RX Acculink)
Arm/Group Description	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.
Measure Participants	1178
Number (95% Confidence Interval) [percentage of participants]	3.4 0.3%

3. Primary Outcome

Title	Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	RX Acculink Carotid Stent System (RX Acculink)
Arm/Group Description	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.
Measure Participants	1200
Number [percentage of participants]	95.6 8%

4. Secondary Outcome

Title	Composite of Peri-procedural Death and Stroke by Symptomatic Status
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	Composite of Peri-procedural DS in the Symptomatic Group	Composite of Peri-procedural DS in the Asymptomatic Group
Arm/Group Description	Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or transient ischemic attack (TIA) (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.	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.
Measure Participants	335	865
Number (95% Confidence Interval) [percentage of participants]	5.8 0.5%	2.5 NaN

5. Secondary Outcome

Title	Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	In Symptomatic Group	In Asymptomatic Group
Arm/Group Description	Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or TIA (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.	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.
Measure Participants	335	865
Number [percentage of participants]	92.5 7.7%	96.8 NaN

6. Secondary Outcome

Title	Composite of Peri-procedural Death and Stroke by Age
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

FAS population. The number of participants analyzed includes subjects with data available at that time frame.

Arm/Group Title	In Octogenarian Group	In Non-octogenarian Group
Arm/Group Description	Octogenarian: A person with age >= 80 years.	Non-octogenarian: A person who is less than 80 years old.
Measure Participants	116	1062
Number (95% Confidence Interval) [percentage of participants]	3.4 0.3%	3.4 NaN

7. Secondary Outcome

Title	Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	In Octogenarian Group	In Non-octogenarian Group
Arm/Group Description	Octogenarian: A person with age >= 80 years.	Non-octogenarian: A person who is less than 80 years old.
Measure Participants	118	1082
Number [percentage of participants]	93.8 7.8%	95.8 NaN

8. Secondary Outcome

Title	Freedom From Clinically Driven Target Lesion Revascularization
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	RX Acculink Carotid Stent System (RX Acculink)
Arm/Group Description	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.
Measure Participants	1200
Number [percentage of participants]	99.9 8.3%

9. Secondary Outcome

Title	Freedom From Clinically Driven Target Lesion Revascularization
Description	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.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	RX Acculink Carotid Stent System (RX Acculink)
Arm/Group Description	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.
Measure Participants	1200
Number [percentage of participants]	99.7 8.3%

10. Secondary Outcome

Title	Freedom From Clinically Driven Target Lesion Revascularization
Description	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.
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	RX Acculink Carotid Stent System (RX Acculink)
Arm/Group Description	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.
Measure Participants	1200
Number [percentage of participants]	99.3 8.3%

11. Secondary Outcome

Title	Clinical Success
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

FAS population

Arm/Group Title	RX Acculink Carotid Stent System (RX Acculink)
Arm/Group Description	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.
Measure Participants	1200
Number (95% Confidence Interval) [percentage of participants]	96.4 8%

Adverse Events

Time Frame	365 Days
Arm/Group Title	RX Acculink Carotid Stent System (RX Acculink)
Arm/Group Description	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.
All Cause Mortality
	RX Acculink Carotid Stent System (RX Acculink)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	RX Acculink Carotid Stent System (RX Acculink)
	Affected / at Risk (%)	# Events
Total	266/1200 (22.2%)
Blood and lymphatic system disorders
GI Bleed	1/1200 (0.1%)
Hematoma	1/1200 (0.1%)
Anemia	7/1200 (0.6%)
Bleeding	1/1200 (0.1%)
Coagulopathy	1/1200 (0.1%)
Cardiac disorders
Abnormal Lab Test	1/1200 (0.1%)
Angina	6/1200 (0.5%)
Arrhythmia (Includes Brady And Tachy)	10/1200 (0.8%)
Coronary artery disease - Coronary stenosis	5/1200 (0.4%)
Cardiac Arrest	6/1200 (0.5%)
Congestive Heart Failure	6/1200 (0.5%)
Dyspnea	2/1200 (0.2%)
Hypertension	1/1200 (0.1%)
Hypotension	7/1200 (0.6%)
Myocardial Infarction - Non Q wave	3/1200 (0.3%)
Myocardial Infarction - Q wave	2/1200 (0.2%)
Myocardial Infarction - Unknown	3/1200 (0.3%)
Peripheral vascular disease	1/1200 (0.1%)
Pain	4/1200 (0.3%)
Surgery/Intervention Procedure	4/1200 (0.3%)
Syncope	2/1200 (0.2%)
Thrombosis	1/1200 (0.1%)
Other	1/1200 (0.1%)
Gastrointestinal disorders
Bleeding	3/1200 (0.3%)
Diverticulitis	1/1200 (0.1%)
GI Bleed	1/1200 (0.1%)
Vomiting	1/1200 (0.1%)
Other	5/1200 (0.4%)
General disorders
Hematoma	1/1200 (0.1%)
Infection At Insertion Site	1/1200 (0.1%)
Other: under access site complication	1/1200 (0.1%)
Abnormal Lab Test	1/1200 (0.1%)
Anxiety	1/1200 (0.1%)
Claudication	1/1200 (0.1%)
Depression	1/1200 (0.1%)
Diarrhea	1/1200 (0.1%)
Other: under miscellaneous category	7/1200 (0.6%)
Anemia	5/1200 (0.4%)
Arrhythmia (Includes Brady And Tachy)	18/1200 (1.5%)
Bleeding	2/1200 (0.2%)
Colitis	1/1200 (0.1%)
Dissection	3/1200 (0.3%)
Embolism	1/1200 (0.1%)
Headache	2/1200 (0.2%)
Hemiparesis	1/1200 (0.1%)
Hypertension	1/1200 (0.1%)
Hypotension	60/1200 (5%)
Incisional Pain	1/1200 (0.1%)
Infection At Insertion Site	1/1200 (0.1%)
Ischemia	1/1200 (0.1%)
No reflow	1/1200 (0.1%)
Pain	2/1200 (0.2%)
Pain At Insertion Site	1/1200 (0.1%)
Pseudoaneurysm	6/1200 (0.5%)
Pulmonary Edema	1/1200 (0.1%)
Transient Ischemia Attack	1/1200 (0.1%)
Vessel Trauma	1/1200 (0.1%)
Viral, Bacterial And Fungal Infections	2/1200 (0.2%)
Immune system disorders
Allergic Reaction To Contrast	1/1200 (0.1%)
Infections and infestations
Sepsis	1/1200 (0.1%)
Urinary Tract Infection	2/1200 (0.2%)
Wound Complication Or Wound Infection	1/1200 (0.1%)
Metabolism and nutrition disorders
Diabetes	1/1200 (0.1%)
Hypercalcemia	1/1200 (0.1%)
Sensory Deficit	1/1200 (0.1%)
Surgery/Intervention Procedure	1/1200 (0.1%)
Musculoskeletal and connective tissue disorders
Arthritis	1/1200 (0.1%)
Back Pain	3/1200 (0.3%)
Cellulitis	1/1200 (0.1%)
Pain	2/1200 (0.2%)
Other	4/1200 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant	4/1200 (0.3%)
Nervous system disorders
Bleeding	1/1200 (0.1%)
Confusion	4/1200 (0.3%)
Delerium	1/1200 (0.1%)
Headache	1/1200 (0.1%)
Mental Status Change	3/1200 (0.3%)
Post Traumatic Hemorrage	1/1200 (0.1%)
Seizure	3/1200 (0.3%)
Speech Disturbance	2/1200 (0.2%)
Syncope	5/1200 (0.4%)
Transient Ischemia Attack	12/1200 (1%)
Vasovagal	1/1200 (0.1%)
Visual Disturbances	2/1200 (0.2%)
Other	2/1200 (0.2%)
Renal and urinary disorders
Hematuria	2/1200 (0.2%)
Kidney Damage Due To Other	2/1200 (0.2%)
Malignant	1/1200 (0.1%)
Renal Artery Disease	1/1200 (0.1%)
Renal Failure	3/1200 (0.3%)
Sepsis	1/1200 (0.1%)
Surgery/Intervention Procedure	1/1200 (0.1%)
Tumor	1/1200 (0.1%)
Urinary Retension	2/1200 (0.2%)
Urinary Tract Infection	3/1200 (0.3%)
Other	1/1200 (0.1%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/1200 (0.1%)
Pleural Effusion	1/1200 (0.1%)
Pneumonia	8/1200 (0.7%)
Pulmonary Edema	1/1200 (0.1%)
Respiratory Failure	6/1200 (0.5%)
Other	1/1200 (0.1%)
Vascular disorders
Cerebrovascular accident - Major Hemorrhagic Ispilateral	3/1200 (0.3%)
Cerebrovascular accident - Major Hemorrhagic Non-Ispilateral	1/1200 (0.1%)
Cerebrovascular accident - Major Ischemic Ispilateral	8/1200 (0.7%)
Cerebrovascular accident - Major Ischemic Non-Ispilateral	2/1200 (0.2%)
Cerebrovascular accident - Minor Hemorrhagic Bilateral	1/1200 (0.1%)
Cerebrovascular accident - Minor Hemorrhagic Ispilateral	2/1200 (0.2%)
Cerebrovascular accident - Minor Hemorrhagic Non-Ispilateral	1/1200 (0.1%)
Cerebrovascular accident - Minor Ischemic Bilateral	3/1200 (0.3%)
Cerebrovascular accident - Minor Ischemic Ispilateral	23/1200 (1.9%)
Cerebrovascular accident - Minor Ischemic Non-Ispilateral	3/1200 (0.3%)
Aneurysm	1/1200 (0.1%)
Claudication	5/1200 (0.4%)
Deep vein thrombosis	1/1200 (0.1%)
Occlusion	3/1200 (0.3%)
Peripheral artery disease	3/1200 (0.3%)
Peripheral vascular disease	3/1200 (0.3%)
Restenosis	10/1200 (0.8%)
Thrombosis	1/1200 (0.1%)
Vascular	1/1200 (0.1%)
Other	4/1200 (0.3%)
Other (Not Including Serious) Adverse Events
	RX Acculink Carotid Stent System (RX Acculink)
	Affected / at Risk (%)	# Events
Total	619/1200 (51.6%)
Blood and lymphatic system disorders
Anemia	1/1200 (0.1%)
Bleeding	3/1200 (0.3%)
Ecchymosis/Bruising	2/1200 (0.2%)
GI Bleed	2/1200 (0.2%)
Hematoma	7/1200 (0.6%)
Abnormal Lab Test	1/1200 (0.1%)
Anemia	13/1200 (1.1%)
Bleeding	2/1200 (0.2%)
Coagulopathy	1/1200 (0.1%)
Leukocytosis	1/1200 (0.1%)
Cardiac disorders
Abnormal Lab Test	2/1200 (0.2%)
Angina	13/1200 (1.1%)
Arrhythmia (Includes Brady And Tachy)	42/1200 (3.5%)
Asystole	3/1200 (0.3%)
Atrial Fibrillation	1/1200 (0.1%)
CAD - Coronary stenosis	5/1200 (0.4%)
Cardiac Arrest	6/1200 (0.5%)
Congestive Heart Failure	8/1200 (0.7%)
Dizziness	1/1200 (0.1%)
Dyspnea	2/1200 (0.2%)
Hypertension	13/1200 (1.1%)
Hypotension	23/1200 (1.9%)
Ischemia	1/1200 (0.1%)
Myocardial Infarction - Non Q wave	3/1200 (0.3%)
Myocardial Infarction - Q wave	2/1200 (0.2%)
Myocardial Infarction - Unknown	3/1200 (0.3%)
Peripheral vascular disease (PVD)	1/1200 (0.1%)
Pain	8/1200 (0.7%)
Spasm	1/1200 (0.1%)
Surgery/Intervention Procedure	5/1200 (0.4%)
Syncope	2/1200 (0.2%)
Thrombosis	1/1200 (0.1%)
Vasovagal	1/1200 (0.1%)
Other	1/1200 (0.1%)
Gastrointestinal disorders
Abdominal Pain	3/1200 (0.3%)
Bleeding	3/1200 (0.3%)
Constipation	1/1200 (0.1%)
Diarrhea	1/1200 (0.1%)
Diverticulitis	1/1200 (0.1%)
Gastroesophageal reflux disease (GERD)	1/1200 (0.1%)
Gastrointestinal (GI) bleed	1/1200 (0.1%)
Nausea	3/1200 (0.3%)
Pain	1/1200 (0.1%)
Vomiting	2/1200 (0.2%)
Other	6/1200 (0.5%)
General disorders
Arrhythmia (Includes Brady And Tachy)	107/1200 (8.9%)
Hypotension	242/1200 (20.2%)
Bleeding	4/1200 (0.3%)
Ecchymosis/Bruising	2/1200 (0.2%)
Hematoma	6/1200 (0.5%)
Infection At Insertion Site	1/1200 (0.1%)
Pain	2/1200 (0.2%)
Pain At Insertion Site	3/1200 (0.3%)
Other	2/1200 (0.2%)
Abnormal Lab Test	4/1200 (0.3%)
Anxiety	1/1200 (0.1%)
Back Pain	1/1200 (0.1%)
Bleeding	1/1200 (0.1%)
Claudication	2/1200 (0.2%)
Cough	1/1200 (0.1%)
Depression	1/1200 (0.1%)
Diarrhea	1/1200 (0.1%)
Dizziness	4/1200 (0.3%)
Edema (Non Pulmonary)	1/1200 (0.1%)
Headache	13/1200 (1.1%)
Hematoma	1/1200 (0.1%)
Joint pain	1/1200 (0.1%)
Nausea	1/1200 (0.1%)
Pain	14/1200 (1.2%)
Rash	1/1200 (0.1%)
Vomiting	2/1200 (0.2%)
Weakness	3/1200 (0.3%)
Other	18/1200 (1.5%)
Abnormal Lab Test	1/1200 (0.1%)
Access site event	1/1200 (0.1%)
Allergic Reaction To Contrast	1/1200 (0.1%)
Anemia	15/1200 (1.3%)
Anxiety	1/1200 (0.1%)
Asystole	4/1200 (0.3%)
Back Pain	3/1200 (0.3%)
Bleeding	10/1200 (0.8%)
Colitis	1/1200 (0.1%)
Dissection	5/1200 (0.4%)
Ecchymosis/Bruising	1/1200 (0.1%)
Embolism	2/1200 (0.2%)
Eye	1/1200 (0.1%)
Headache	20/1200 (1.7%)
Hematoma	19/1200 (1.6%)
Hemiparesis	1/1200 (0.1%)
Hemorrhage	1/1200 (0.1%)
Hypertension	23/1200 (1.9%)
Incisional Pain	1/1200 (0.1%)
Incontinence	1/1200 (0.1%)
Infection At Insertion Site	2/1200 (0.2%)
Ischemia	1/1200 (0.1%)
Jaw Pain	1/1200 (0.1%)
Mental Status Change	2/1200 (0.2%)
Nausea	18/1200 (1.5%)
Neuralgia	1/1200 (0.1%)
No reflow	1/1200 (0.1%)
Oozing	1/1200 (0.1%)
Pain	13/1200 (1.1%)
Pain At Insertion Site	6/1200 (0.5%)
Paralysis	1/1200 (0.1%)
Pseudoaneurysm	8/1200 (0.7%)
Pulmonary Edema	1/1200 (0.1%)
Renal Insufficiency	1/1200 (0.1%)
Spasm	4/1200 (0.3%)
Speech Disturbance	1/1200 (0.1%)
Syncope	1/1200 (0.1%)
Thrombosis	2/1200 (0.2%)
Transient Ischemia Attack	3/1200 (0.3%)
Urinary Retension	2/1200 (0.2%)
Vasospasm	4/1200 (0.3%)
Vasovagal	3/1200 (0.3%)
Vessel Trauma	1/1200 (0.1%)
Viral, Bacterial And Fungal Infections	2/1200 (0.2%)
Visual Disturbances	4/1200 (0.3%)
Vomiting	3/1200 (0.3%)
Weakness	2/1200 (0.2%)
Other	11/1200 (0.9%)
Immune system disorders
Allergic Reaction To Contrast	4/1200 (0.3%)
Rash	6/1200 (0.5%)
Other	5/1200 (0.4%)
Infections and infestations
Cellulitis	2/1200 (0.2%)
Eye	1/1200 (0.1%)
Sepsis	1/1200 (0.1%)
Urinary Tract Infection	3/1200 (0.3%)
Viral, Bacterial And Fungal Infections	3/1200 (0.3%)
Wound Complication Or Wound Infection	1/1200 (0.1%)
Metabolism and nutrition disorders
Abnormal Lab Test	1/1200 (0.1%)
Diabetes	1/1200 (0.1%)
Hypercalcemia	1/1200 (0.1%)
Hypokalemia	1/1200 (0.1%)
Joint pain	1/1200 (0.1%)
Sensory Deficit	1/1200 (0.1%)
Surgery/Intervention Procedure	1/1200 (0.1%)
Other	1/1200 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/1200 (0.1%)
Arthritis	1/1200 (0.1%)
Back Pain	5/1200 (0.4%)
Cellulitis	1/1200 (0.1%)
Headache	2/1200 (0.2%)
Hematoma	1/1200 (0.1%)
Myalgia	2/1200 (0.2%)
Pain	6/1200 (0.5%)
Weakness	2/1200 (0.2%)
Other	5/1200 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant	4/1200 (0.3%)
Nervous system disorders
Bleeding	1/1200 (0.1%)
Confusion	7/1200 (0.6%)
Delerium	1/1200 (0.1%)
Dizziness	10/1200 (0.8%)
Headache	9/1200 (0.8%)
Mental Status Change	6/1200 (0.5%)
Nausea	1/1200 (0.1%)
Neuralgia	1/1200 (0.1%)
Neuropathy	2/1200 (0.2%)
Numbness	1/1200 (0.1%)
Paralysis	2/1200 (0.2%)
Post Traumatic Hemorrage	1/1200 (0.1%)
Seizure	5/1200 (0.4%)
Sensory Deficit	1/1200 (0.1%)
Speech Disturbance	7/1200 (0.6%)
Syncope	10/1200 (0.8%)
Transient Ischemia Attack	21/1200 (1.8%)
Vasovagal	1/1200 (0.1%)
Visual Disturbances	13/1200 (1.1%)
Weakness	1/1200 (0.1%)
Other	17/1200 (1.4%)
Renal and urinary disorders
Abnormal Lab Test	2/1200 (0.2%)
Dysuria	1/1200 (0.1%)
Hematuria	3/1200 (0.3%)
Incontinence	1/1200 (0.1%)
Kidney Damage Due To Other	2/1200 (0.2%)
Malignant	1/1200 (0.1%)
Renal Artery Disease	1/1200 (0.1%)
Renal Failure	3/1200 (0.3%)
Sepsis	1/1200 (0.1%)
Surgery/Intervention Procedure	1/1200 (0.1%)
Tumor	1/1200 (0.1%)
Urinary Retension	5/1200 (0.4%)
Urinary Tract Infection	6/1200 (0.5%)
Viral, Bacterial And Fungal Infections	1/1200 (0.1%)
Other	1/1200 (0.1%)
Respiratory, thoracic and mediastinal disorders
Bronchitis	2/1200 (0.2%)
Chronic obstructive pulmonary disease	1/1200 (0.1%)
Dyspnea	4/1200 (0.3%)
Pleural Effusion	1/1200 (0.1%)
Pneumonia	9/1200 (0.8%)
Pulmonary Edema	2/1200 (0.2%)
Respiratory Failure	6/1200 (0.5%)
Viral, Bacterial And Fungal Infections	1/1200 (0.1%)
Other	1/1200 (0.1%)
Vascular disorders
Cerebrovascular accident (CVA) - Major Hemorrhagic Ispilateral	3/1200 (0.3%)
Cerebrovascular accident (CVA)-Major Hemorrhagic Non-Ispilateral	1/1200 (0.1%)
Cerebrovascular accident (CVA) - Major Ischemic Ispilateral	8/1200 (0.7%)
Cerebrovascular accident (CVA) - Major Ischemic Non-Ispilateral	2/1200 (0.2%)
Cerebrovascular accident (CVA) - Minor Hemorrhagic Bilateral	1/1200 (0.1%)
Cerebrovascular accident (CVA) - Minor Hemorrhagic Ispilateral	2/1200 (0.2%)
Cerebrovascular accident (CVA) - Minor Hemorrhagic Non-Ispilateral	1/1200 (0.1%)
Cerebrovascular accident (CVA) - Minor Ischemic Bilateral	3/1200 (0.3%)
Cerebrovascular accident (CVA) - Minor Ischemic Ispilateral	25/1200 (2.1%)
Cerebrovascular accident (CVA) - Minor Ischemic Non-Ispilateral	4/1200 (0.3%)
Aneurysm	3/1200 (0.3%)
Arrhythmia (Includes Brady And Tachy)	2/1200 (0.2%)
Claudication	6/1200 (0.5%)
Deep venous thrombosis (DVT)	2/1200 (0.2%)
Dissection	1/1200 (0.1%)
Occlusion	4/1200 (0.3%)
Peripheral artery disease (PAD)	3/1200 (0.3%)
Peripheral vascular disease (PVD)	4/1200 (0.3%)
Restenosis	10/1200 (0.8%)
Spasm	2/1200 (0.2%)
Surgery/Intervention Procedure	1/1200 (0.1%)
Syncope	1/1200 (0.1%)
Thrombosis	2/1200 (0.2%)
Vascular	1/1200 (0.1%)
Vasospasm	1/1200 (0.1%)
Vasovagal	1/1200 (0.1%)
Other	4/1200 (0.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.