Carotid Angioplasty and Stenting Versus Endarterectomy in... | NCT00106938

Label	Type	Description	Intervention Names
1	Active Comparator	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.	Device: Carotid artery stenting with filter (interventional)
2	Active Comparator	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.	Procedure: Carotid artery endarterectomy (surgical)

Name	Type	Description	Arm Group Labels	Other Names
Carotid artery stenting with filter (interventional)	Device	Carotid artery stenting with filter (interventional)	1

Measure	Description	Time Frame
Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days.		0 to 365 days

Measure	Description	Time Frame
Acute Device Success: Xact Carotid Stent	Defined as attainment of final residual diameter stenosis of < 50% by Qualitative Comparative Analysis (QCA) (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject must be > 18 and < 80 years of age.
Female subjects of child bearing potential must have a documented negative pregnancy test within 30 days prior to the study procedure.
Subject must be asymptomatic, defined as no stroke or Transient Ischemic Attack [(TIA);(hemispheric or ocular)] within the 180 days prior to the procedure. Subjects who have experienced these neurological symptoms prior to the 180 day pre-procedure window will be eligible for enrollment. An independent study neurologist or independent study neurosurgeon must confirm the subject's neurological status.
Subjects taking warfarin may be included if their dosage is reduced before the procedure to result in an International Normalized Ratio (INR) of 1.5 or less. Warfarin may be restarted after the procedure.
The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local institutional review board (IRB).
The subject must agree to return for all required follow-up visits.
Subject has a discrete lesion located in the internal carotid artery (ICA); the contiguous common carotid artery (CCA) may be involved.
Carotid stenosis ≥ 70% and ≤ 99% by carotid ultrasound or ≥ 70% and ≤ 99% stenosis (visual estimate) by angiography, without significant (> 60% by ultrasound or angiography) ICA/CCA contralateral stenosis.
Target ICA vessel diameter must be visually estimated to be:

> 2.5 mm and < 7.0 for the Emboshield Pro or for the Emboshield NAV6, > 2.8 mm and < 6.2 for the Emboshield Gen 3 And > 4.0 mm and < 9.0 mm for the Xact stent treatment segment. An untreated contralateral ICA may be used for visual estimation when a highly stenosed lesion makes measurement of the target vessel inaccurate.
Based on the subject's anatomy, the Investigator should expect to successfully deliver the stent to the target lesion (absence of extreme tortuosity, etc.).
De novo target lesion that can be treated with a single stent.

Exclusion Criteria:

Each potential subject must be screened to ensure that they do not meet any of the following exclusion criteria. This screening is to be based on known medical history and data available at the time of eligibility determination and enrollment.

Subject is symptomatic and has had a stroke or exhibited TIA (hemispheric or ocular) within 180 days prior to randomization, which has been confirmed by an independent study neurologist or independent study neurosurgeon.
Subject is participating in another drug or device trial (IND or IDE) that has not completed the primary endpoint or that may potentially confound the results of this trial. Subject may be enrolled only once in this trial and may not participate in any other clinical trial during a 1-year period post-index procedure.
Subject has inability to understand and cooperate with study procedures or provide informed consent.
Subject has had an intracranial hemorrhage or hemorrhagic stroke within 1-year prior the index procedure.
Subject has dementia or has a neurological illness that may confound the neurological evaluation.
Subject has had a known untoward reaction to anesthesia or contrast media not able to be overcome by pre-treatment with medications.
Subject has history of intolerance or allergic reaction to any of the study medications including aspirin, Clopidogrel bisulfate (Plavix®) or Ticlopidine (Ticlid®), heparin or Bivalirudin (Angiomax™). Subjects must be able to tolerate a combination of aspirin and Clopidogrel/Ticlopidine.
Subject has Hemoglobin (Hgb) less than 10 gm/dL, platelet count <100,000/mm3 or >500,000/mm3, or known heparin associated thrombocytopenia.
Subject has an active bleeding diathesis or coagulopathy, or will refuse blood transfusions.
Subject has had a GI bleed that would interfere with antiplatelet therapy.
Subject has known cardiac sources of emboli, including paroxysmal or sustained atrial fibrillation (treated or untreated).
Subject has had an myocardial infarction (MI) within the previous 30 days.
Subject has any condition that limits their anticipated survival to less than 3 years.
Subject is a high risk surgical candidate defined as the presence of any one or more of a following medical conditions:
1. Two or more proximal diseased coronary arteries of > 70% stenosis that have not or cannot be revascularized or < 30 days since revascularization.
2. Ejection fraction < 30% or New York Heart Association (NYHA) heart failure functional class 3 or higher.
3. Unstable angina, defined as angina at rest with ECG changes.
4. On a list for major organ transplant or is being evaluated for such.
5. Known history of respiratory insufficiency, forced expiratory volume (FEV1) < 30% (predicted).
6. Chronic renal insufficiency (serum creatinine >2.5 mg/dL).
7. Uncontrolled diabetes defined as fasting glucose > 400 mg/dL.
8. Concurrent requirement for any invasive procedure 30 days pre- or post-procedure.
9. Age ≥ 80 years.
Subject may be considered a non-surgical candidate for CEA as a result of one or more anatomic conditions or features which preclude normal surgical access or a high surgical risk because of the presence of any one or more anatomic conditions that present an increased potential for adverse events. These subjects are not eligible for enrollment.
1. Subject has had radiation treatment to the neck.
2. Subject has had a radical neck dissection.
3. Surgically inaccessible lesions (i.e., lesions extending above the level of C2).
4. Spinal immobility - inability to flex neck beyond neutral or kyphotic deformity.
5. Presence of carotid artery dissection, aneurysm, pseudoaneurysm, arteritis or fibromuscular dysplasia (FMD) in the target vessel.
6. Hemodynamically significant (>60%) stenosis of the right or left common carotid artery (LCCA/RCCA) below the clavicle.
7. Presence of tracheostomy stoma.
8. Contralateral laryngeal nerve paralysis.
9. Previous carotid endarterectomy, extracranial-intracranial or carotid subclavian bypass procedure ipsilateral to the carotid stenosis.
10. Severe hypertension (defined as blood pressure > Systolic of 180 mm Hg and/or a diastolic of 110 mm Hg) not adequately controlled by anti-hypertensive therapy at the time of study entry.
Severe vascular disease including tortuosity and/or occlusive disease that would preclude the safe introduction of a guiding catheter/sheath, cerebral protection device, balloon catheter, stent delivery system or stent placement. Severe tortuosity is defined as 2 or more >90 degree bend points within 3cm of the target stenosis. One of these bends will be considered to be present if the ICA branches from the CCA at a 90 degree angle. This includes aortic arch anatomy that is unacceptable for carotid stent placement.
Intraluminal filling defect thought to represent thrombus.
Excessive calcification: defined as fluoroscopic evidence of calcium that extends circumferentially around the target lesion and includes the majority of the atherosclerotic plaque.
Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.
The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) prior to stent placement.
Significant (> 60%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off.
Presence of a previously placed intravascular stent in the ipsilateral carotid distribution.
Cerebral aneurysm (symptomatic or > 10 mm) or arteriovenous malformation (AVM) of the cerebral vasculature.
Bilateral carotid stenosis (ICA/CCA contralateral stenosis > 60% by ultrasound or angiography).

Name	Affiliation	Role
Jon Matsumura, MD	University of Wisconsin, Madison	Principal Investigator
Kenneth Rosenfield, MD	Massachusetts General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
St. Luke's Hospital-Phoenix		Phoenix	Arizona	85006	United States
Mayo Clinic

PubMed Identifier	Type	Citation	Retractions
28982691	Derived	Weinberg I, Beckman JA, Matsumura JS, Rosenfield K, Ansel GM, Chaturvedi S, Gray W, Metzger DC, Riles T, Shu Y, Wechsler L, Jaff MR. Carotid Stent Fractures Are Not Associated With Adverse Events: Results From the ACT-1 Multicenter Randomized Trial (Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease). Circulation. 2018 Jan 2;137(1):49-56. doi: 10.1161/CIRCULATIONAHA.117.030030. Epub 2017 Oct 5.
26886419

ID	Title	Description
FG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
FG001	CEA Group

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days.

Posted

Number

percentage of participants

0 to 365 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG0001089 OG001364

Title

Denominators

Categories

Title	Measurements
	OG0003.8 OG0013.4

Secondary

Acute Device Success: Xact Carotid Stent

Defined as attainment of final residual diameter stenosis of < 50% by Qualitative Comparative Analysis (QCA) (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.

Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.

Posted

Number

95% Confidence Interval

percentage of devices

On day 0 after index procedure

devices

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Acute Device Success: Embolic Protection Device System

Defined as successful deployment and retrieval of the filter in the absence of angiographic distal embolization.

Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.

Posted

Mean

95% Confidence Interval

Percentage of devices

On day 0 after index procedure

Devices

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Procedural Success

Procedural success is defined as the attainment of target lesion final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days.

The analysis population is Procedure success is per subject basis including the attempted CAS (carotid artery stenting) procedure only. CEA group is not part of analysis population for procedure success.

Posted

Number

percentage of participants

0 to 30 days post procedure

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Composite Morbidity Measure

A pre-specified composite Morbidity Measure (CMM) of cranial and peripheral nerve injury, vascular injury, non-cerebral bleeding, wound complications related to the neck incision or femoral puncture site, and other complications (anesthetic) at 30 days post-procedure.

Intent-to-Treat (ITT) population

Posted

Number

participants

0 to 30 Days Post-procedure

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)

Freedom from CI-TLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.

Posted

Number

percentage of partcipants

0 to 180 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Clinically Indicated Target Lesion Revascularization

Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.

Posted

Number

percentage of partcipants

0 to 365 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Clinically Indicated Target Lesion Revascularization

Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.

Posted

Number

percentage of partcipants

0 to 730 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Clinically Indicated Target Lesion Revascularization

Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.

Posted

Number

percentage of partcipants

0 to 1095 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Clinically Indicated Target Lesion Revascularization

Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.

Posted

Number

percentage of partcipants

0 to 1460 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Clinically Indicated Target Lesion Revascularization

Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.

Posted

Number

percentage of partcipants

0 to 1825 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Ipsilateral Stroke

Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.

Posted

Number

percentage of participants

31 to 365 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Ipsilateral Stroke

Posted

Number

percentage of participants

31 to 730 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Ipsilateral Stroke

Posted

Number

percentage of participants

31 to 1095 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Ipsilateral Stroke

Posted

Number

percentage of participants

31 to 1460 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Ipsilateral Stroke

Posted

Number

percentage of participants

31 to 1825 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Mortality

Posted

Number

percentage of participants

0 to 365 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Mortality

Posted

Number

percentage of participants

0 to 730 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Mortality

Posted

Number

percentage of partcipants

0 to 1095 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Mortality

Posted

Number

percentage of participants

0 to 1460 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Mortality

Posted

Number

percentage of participants

0 to 1825 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From All Stroke

Posted

Number

percentage of participants

0 to 365 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From All Stroke

Posted

Number

percentage of participants

0 to 730 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From All Stroke

Posted

Number

percentage of participants

0 to 1095 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From All Stroke

Posted

Number

percentage of participants

0 to 1460 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From All Stroke

Posted

Number

percentage of participants

0 to 1825 days

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Death (Non-Hierarchical)

Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.

Posted

Number

95% Confidence Interval

percentage of participants

≤ 30 Days Post Index Procedure

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

All Stroke (Non-Hierarchical)

Posted

Number

95% Confidence Interval

percentage of participants

≤ 30 Days Post Index Procedure

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Myocardial Infarction (MI) (Non-Hierarchical)

Posted

Number

95% Confidence Interval

percentage of participants

≤ 30 Days Post Index Procedure

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Death, Stroke or Myocardial Infarction (MI) (Hierarchical)

Posted

Number

95% Confidence Interval

percentage of participants

≤ 30 Days Post Index Procedure

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Death or Stroke (Hierarchical)

Posted

Number

95% Confidence Interval

percentage of participants

≤ 30 Days Post Index Procedure

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Death or Major Stroke (Hierarchical)

Posted

Number

95% Confidence Interval

percentage of participants

≤ 30 Days Post Index Procedure

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Secondary

Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years

Posted

Number

percentage of participants

0 to 5 years

ID	Title	Description
OG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
OG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bleeding	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0008 events7 affected1,089 at risk EG0013 events3 affected364 at risk
Hematoma	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected1,089 at risk EG0013 events3 affected364 at risk
Infection	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0006 events3 affected1,089 at risk EG0013 events3 affected364 at risk
Occlusion	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected1,089 at risk EG0010 events0 affected364 at risk
Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Vessel trauma	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Epistaxis	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected1,089 at risk EG0010 events0 affected364 at risk
GI bleed	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG00015 events15 affected1,089 at risk EG0018 events8 affected364 at risk
Genitourinary	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected1,089 at risk EG0010 events0 affected364 at risk
Vascular	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected1,089 at risk EG0012 events2 affected364 at risk
Anemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG00015 events13 affected1,089 at risk EG0013 events3 affected364 at risk
Abnormal lab test	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Arrhythmia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00025 events22 affected1,089 at risk EG0015 events4 affected364 at risk
Cardiac arrest	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events5 affected1,089 at risk EG0013 events3 affected364 at risk
Congestive heart failure	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00012 events10 affected1,089 at risk EG0011 events1 affected364 at risk
Coronary artery disease	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00070 events57 affected1,089 at risk EG00125 events21 affected364 at risk
Pulmonary hypertension	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected1,089 at risk EG0010 events0 affected364 at risk
Structural heart disease	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected1,089 at risk EG0010 events0 affected364 at risk
Myocardial infarction	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00016 events14 affected1,089 at risk EG0015 events5 affected364 at risk
Hypertension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0006 events6 affected1,089 at risk EG0012 events2 affected364 at risk
Hypotension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0008 events7 affected1,089 at risk EG0011 events1 affected364 at risk
Syncope	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected1,089 at risk EG0011 events1 affected364 at risk
Confusion	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Cranial nerve palsy	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Dizziness	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0013 events3 affected364 at risk
Encephalopathy	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected1,089 at risk EG0011 events1 affected364 at risk
Headache	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Hyperperfusion syndrome	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Neurologic other	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00013 events13 affected1,089 at risk EG0015 events3 affected364 at risk
Peripheral neuropathy	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Seizure	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events5 affected1,089 at risk EG0011 events1 affected364 at risk
Subdural hematoma	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected1,089 at risk EG0010 events0 affected364 at risk
TIA	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0008 events7 affected1,089 at risk EG0012 events2 affected364 at risk
Visual disturbance	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected1,089 at risk EG0010 events0 affected364 at risk
Ipsilateral major	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events7 affected1,089 at risk EG0011 events1 affected364 at risk
Ipsilateral minor	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00020 events20 affected1,089 at risk EG0016 events6 affected364 at risk
Non-ipsilateral major	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected1,089 at risk EG0010 events0 affected364 at risk
Non-ipsilateral minor	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected1,089 at risk EG0010 events0 affected364 at risk
Anesthesia/Procedural medication related	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected1,089 at risk EG0012 events2 affected364 at risk
Arrhythmia	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG00018 events17 affected1,089 at risk EG0013 events3 affected364 at risk
Bleeding	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG00011 events11 affected1,089 at risk EG0010 events0 affected364 at risk
Cranial nerve injury	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected1,089 at risk EG0013 events3 affected364 at risk
Fluid overload	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Headache	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected1,089 at risk EG0011 events1 affected364 at risk
Heparin induced thrombocytopenia	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Hypertension	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0006 events5 affected1,089 at risk EG0017 events7 affected364 at risk
Hypotension	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG00069 events69 affected1,089 at risk EG0017 events7 affected364 at risk
Spasm	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Urinary retention	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0012 events2 affected364 at risk
Vessel trauma	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0007 events7 affected1,089 at risk EG0010 events0 affected364 at risk
Abdominal Aortic Aneurysm	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected1,089 at risk EG0012 events2 affected364 at risk
Carotid artery disease	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Contralateral stenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events7 affected1,089 at risk EG0013 events3 affected364 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected1,089 at risk EG0011 events1 affected364 at risk
Occlusion	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Peripheral vascular disease	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00056 events41 affected1,089 at risk EG00120 events11 affected364 at risk
Pulmonary embolism	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Renal artery disease	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00010 events10 affected1,089 at risk EG0011 events1 affected364 at risk
Restenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected1,089 at risk EG0010 events0 affected364 at risk
Stenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected1,089 at risk EG0011 events1 affected364 at risk
Target lesion restenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0008 events8 affected1,089 at risk EG00110 events9 affected364 at risk
Allergic reaction	Immune system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected1,089 at risk EG0010 events0 affected364 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG00023 events21 affected1,089 at risk EG00110 events8 affected364 at risk
Gastrointestinal	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00039 events29 affected1,089 at risk EG0013 events3 affected364 at risk
Genitourinary	General disorders	MedDRA (11.0)	Systematic Assessment	EG00028 events25 affected1,089 at risk EG0011 events1 affected364 at risk
Infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00025 events23 affected1,089 at risk EG0016 events6 affected364 at risk
Mental health related	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected1,089 at risk EG0013 events2 affected364 at risk
Metabolic	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG00010 events10 affected1,089 at risk EG0011 events1 affected364 at risk
Miscellaneous	General disorders	MedDRA (11.0)	Systematic Assessment	EG00014 events14 affected1,089 at risk EG0016 events4 affected364 at risk
Musculoskeletal	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00045 events41 affected1,089 at risk EG0017 events7 affected364 at risk
Respiratory	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG00024 events19 affected1,089 at risk EG0019 events9 affected364 at risk
Trauma	General disorders	MedDRA (11.0)	Systematic Assessment	EG00015 events13 affected1,089 at risk EG0016 events6 affected364 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anesthesia/Procedural medication related	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG00070 events65 affected1,089 at risk EG00155 events51 affected364 at risk
Arrhythmia	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG000148 events140 affected1,089 at risk EG00120 events20 affected364 at risk
Cranial nerve injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG00015 events14 affected1,089 at risk EG00151 events48 affected364 at risk
Headache	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG00074 events73 affected1,089 at risk EG00131 events30 affected364 at risk
Hypertension	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG00040 events40 affected1,089 at risk EG00129 events29 affected364 at risk
Hypotension	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG000268 events252 affected1,089 at risk EG00136 events35 affected364 at risk
Pain	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG00060 events56 affected1,089 at risk EG00166 events64 affected364 at risk
Other	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG000115 events93 affected1,089 at risk EG00141 events33 affected364 at risk
Other	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00092 events81 affected1,089 at risk EG00131 events23 affected364 at risk
Other	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG00058 events51 affected1,089 at risk EG00125 events24 affected364 at risk
Other	General disorders	MedDRA (11.0)	Systematic Assessment	EG000140 events107 affected1,089 at risk EG00147 events40 affected364 at risk
Other	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG000211 events173 affected1,089 at risk EG00136 events28 affected364 at risk
Other	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG00066 events56 affected1,089 at risk EG00120 events18 affected364 at risk

ID	Term
D002340	Carotid Artery Diseases
D016893	Carotid Stenosis
D020521	Stroke
D050197	Atherosclerosis

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001157	Arterial Occlusive Diseases
D001161	Arteriosclerosis

ID	Term
D008722	Methods
D016894	Endarterectomy, Carotid
D013514	Surgical Procedures, Operative

ID	Term
D008919	Investigative Techniques
D004691	Endarterectomy
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures

ID	Title	Description
BG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
BG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CAS Group	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.			376	1,089	635	1,089
EG001	CEA Group	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.			118	364	216	364