Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00106938
• Collaborator: (none)
• Enrollment: 1,663
• Locations: 62
• Arms: 2
• Duration (Months): 95
• Patients Per Site: 26.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Disease; Carotid Stenosis; Stroke; Atherosclerosis	Device: Carotid artery stenting with filter (interventional); Procedure: Carotid artery endarterectomy (surgical)	N/A

Detailed Description

Randomization for ACT 1 employs a 3:1 ratio of CAS versus CEA. A lead-in phase of up to 400 carotid stent subjects will provide investigators experience with the study devices prior to pivotal enrollment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1663 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 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); Carotid artery stenting with filter (interventional)
Active Comparator: 2 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); Carotid artery endarterectomy (surgical)

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. Acute Device Success: Xact Carotid Stent [On day 0 after index procedure]

   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.

2. Acute Device Success: Embolic Protection Device System [On day 0 after index procedure]

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

3. Procedural Success [0 to 30 days post procedure]

   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.

4. Composite Morbidity Measure [0 to 30 Days Post-procedure]

   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.

5. Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR) [0 to 180 days]

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

6. Freedom From Clinically Indicated Target Lesion Revascularization [0 to 365 days]

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

7. Freedom From Clinically Indicated Target Lesion Revascularization [0 to 730 days]

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

8. Freedom From Clinically Indicated Target Lesion Revascularization [0 to 1095 days]

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

9. Freedom From Clinically Indicated Target Lesion Revascularization [0 to 1460 days]

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

10. Freedom From Clinically Indicated Target Lesion Revascularization [0 to 1825 days]

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

11. Freedom From Ipsilateral Stroke [31 to 365 days]

    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.

12. Freedom From Ipsilateral Stroke [31 to 730 days]

    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.

13. Freedom From Ipsilateral Stroke [31 to 1095 days]

    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.

14. Freedom From Ipsilateral Stroke [31 to 1460 days]

    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.

15. Freedom From Ipsilateral Stroke [31 to 1825 days]

    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.

16. Freedom From Mortality [0 to 365 days]

17. Freedom From Mortality [0 to 730 days]

18. Freedom From Mortality [0 to 1095 days]

19. Freedom From Mortality [0 to 1460 days]

20. Freedom From Mortality [0 to 1825 days]

21. Freedom From All Stroke [0 to 365 days]

22. Freedom From All Stroke [0 to 730 days]

23. Freedom From All Stroke [0 to 1095 days]

24. Freedom From All Stroke [0 to 1460 days]

25. Freedom From All Stroke [0 to 1825 days]

26. Death (Non-Hierarchical) [≤ 30 Days Post Index Procedure]

27. All Stroke (Non-Hierarchical) [≤ 30 Days Post Index Procedure]

28. Myocardial Infarction (MI) (Non-Hierarchical) [≤ 30 Days Post Index Procedure]

29. Death, Stroke or Myocardial Infarction (MI) (Hierarchical) [≤ 30 Days Post Index Procedure]

30. Death or Stroke (Hierarchical) [≤ 30 Days Post Index Procedure]

31. Death or Major Stroke (Hierarchical) [≤ 30 Days Post Index Procedure]

32. Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years [0 to 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The subject must be > 18 and < 80 years of age.

2. Female subjects of child bearing potential must have a documented negative pregnancy test within 30 days prior to the study procedure.

3. 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.

4. 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.

5. 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).

6. The subject must agree to return for all required follow-up visits.

7. Subject has a discrete lesion located in the internal carotid artery (ICA); the contiguous common carotid artery (CCA) may be involved.

8. 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.

9. 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.

1. Based on the subject's anatomy, the Investigator should expect to successfully deliver the stent to the target lesion (absence of extreme tortuosity, etc.).

2. 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.

1. 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.

2. 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.

3. Subject has inability to understand and cooperate with study procedures or provide informed consent.

4. Subject has had an intracranial hemorrhage or hemorrhagic stroke within 1-year prior the index procedure.

5. Subject has dementia or has a neurological illness that may confound the neurological evaluation.

6. Subject has had a known untoward reaction to anesthesia or contrast media not able to be overcome by pre-treatment with medications.

7. 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.

8. Subject has Hemoglobin (Hgb) less than 10 gm/dL, platelet count <100,000/mm3 or

500,000/mm3, or known heparin associated thrombocytopenia.

1. Subject has an active bleeding diathesis or coagulopathy, or will refuse blood transfusions.

2. Subject has had a GI bleed that would interfere with antiplatelet therapy.

3. Subject has known cardiac sources of emboli, including paroxysmal or sustained atrial fibrillation (treated or untreated).

4. Subject has had an myocardial infarction (MI) within the previous 30 days.

5. Subject has any condition that limits their anticipated survival to less than 3 years.

6. Subject is a high risk surgical candidate defined as the presence of any one or more of a following medical conditions:

7. Two or more proximal diseased coronary arteries of > 70% stenosis that have not or cannot be revascularized or < 30 days since revascularization.

8. Ejection fraction < 30% or New York Heart Association (NYHA) heart failure functional class 3 or higher.

9. Unstable angina, defined as angina at rest with ECG changes.

10. On a list for major organ transplant or is being evaluated for such.

11. Known history of respiratory insufficiency, forced expiratory volume (FEV1) < 30% (predicted).

12. Chronic renal insufficiency (serum creatinine >2.5 mg/dL).

13. Uncontrolled diabetes defined as fasting glucose > 400 mg/dL.

14. Concurrent requirement for any invasive procedure 30 days pre- or post-procedure.

15. Age ≥ 80 years.

16. 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.

17. Subject has had radiation treatment to the neck.

18. Subject has had a radical neck dissection.

19. Surgically inaccessible lesions (i.e., lesions extending above the level of C2).

20. Spinal immobility - inability to flex neck beyond neutral or kyphotic deformity.

21. Presence of carotid artery dissection, aneurysm, pseudoaneurysm, arteritis or fibromuscular dysplasia (FMD) in the target vessel.

22. Hemodynamically significant (>60%) stenosis of the right or left common carotid artery (LCCA/RCCA) below the clavicle.

23. Presence of tracheostomy stoma.

24. Contralateral laryngeal nerve paralysis.

25. Previous carotid endarterectomy, extracranial-intracranial or carotid subclavian bypass procedure ipsilateral to the carotid stenosis.

26. 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.

27. 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.

28. Intraluminal filling defect thought to represent thrombus.

29. Excessive calcification: defined as fluoroscopic evidence of calcium that extends circumferentially around the target lesion and includes the majority of the atherosclerotic plaque.

30. Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.

31. The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) prior to stent placement.

32. Significant (> 60%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off.

33. Presence of a previously placed intravascular stent in the ipsilateral carotid distribution.

34. Cerebral aneurysm (symptomatic or > 10 mm) or arteriovenous malformation (AVM) of the cerebral vasculature.

35. Bilateral carotid stenosis (ICA/CCA contralateral stenosis > 60% by ultrasound or angiography).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Luke's Hospital-Phoenix	Phoenix	Arizona	United States	85006
2	Mayo Clinic	Phoenix	Arizona	United States	85054
3	Fogarty Clinical Research Inc./El Camino Hospital	Mountain View	California	United States	94040
4	Hoag Memorial Hospital	Newport Beach	California	United States	92663
5	St. Joseph Hospital	Orange	California	United States	92868
6	Kaiser Foundation Hospital-San Diego	San Diego	California	United States	92120
7	Washington Hospital Center	Washington, D.C.	District of Columbia	United States	20010
8	Baptist Cardiac and Vascular Institute	Miami	Florida	United States	33176
9	Piedmont Hospital	Atlanta	Georgia	United States	30309
10	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
11	Hawaii Permanente Medical Group - Kaiser	Honolulu	Hawaii	United States	96817
12	Northwestern University Memorial Hospital	Chicago	Illinois	United States	60611
13	Rush University Medical Center	Chicago	Illinois	United States	60612
14	St. John's Hospital and Memorial Medical Center/ Prairie Heart Cooperative	Springfield	Illinois	United States	62701
15	Parkview Hospital	Fort Wayne	Indiana	United States	46805
16	Central Baptist Hospital	Lexington	Kentucky	United States	40503
17	University of Louisville	Louisville	Kentucky	United States	40292
18	Cardiovascular Institute of the South	Lafayette	Louisiana	United States	70506
19	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
20	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224
21	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
22	Harper University Hospital/Detroit Medical Center	Detroit	Michigan	United States	48201
23	McLaren Regional Medical Center	Flint	Michigan	United States	48507
24	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
25	St. John's Mercy Medical Center	Saint Louis	Missouri	United States	63141
26	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
27	Our Lady of Lourdes Medical Center	Camden	New Jersey	United States	08103
28	Albany Medical Center	Albany	New York	United States	12208
29	Millard Fillmore Hospital	Buffalo	New York	United States	14209
30	NYU Medical Center	New York	New York	United States	10016
31	Columbia Presbyterian Hospital	New York	New York	United States	10021
32	Lenox Hill Hospital	New York	New York	United States	10021
33	University of Rochester-Strong Memorial Hospital	Rochester	New York	United States	14623
34	St. Francis Hospital	Roslyn	New York	United States	11576
35	Duke University Medical Center	Durham	North Carolina	United States	27609
36	WakeMed Health and Hospital	Raleigh	North Carolina	United States	27610
37	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
38	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
39	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
40	Oregon Health and Science University Stroke Center	Portland	Oregon	United States	97239
41	Heritage Valley Health System	Beaver	Pennsylvania	United States	15009
42	Harrisburg Hospital / Pinnacle Health	Harrisburg	Pennsylvania	United States	17110
43	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
44	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania	United States	15213
45	University of Pittsburgh Physicians Division of Vascular Surgery/Shadyside Medical	Pittsburgh	Pennsylvania	United States	15232
46	Allegheny General Hospital	Washington	Pennsylvania	United States	15301
47	St. Joseph's Medical Center/Berks Cardiologists	Wyomissing	Pennsylvania	United States	19610
48	Providence Hospital-SC	Columbia	South Carolina	United States	29204
49	North Central Heart Institute	Sioux Falls	South Dakota	United States	57108
50	The Stern Cardiovascular Center/Methodist Germantown Hospital	Germantown	Tennessee	United States	38138
51	Wellmont Holston Valley Medical Center	Kingsport	Tennessee	United States	37660
52	Mercy Medical West/Turkey Creek Medical Center	Knoxville	Tennessee	United States	37934
53	Westlake Medical Center/Seton Heart Institute	Austin	Texas	United States	78705
54	Heart Hospital of Austin	Austin	Texas	United States	78756
55	Dallas Veteran's Administration Medical Center	Dallas	Texas	United States	75216
56	Presbyterian Hospital of Dallas	Dallas	Texas	United States	75231
57	St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
58	Chesapeake General Hospital/Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
59	St. Mary's Hospital / Virginia Cardiovascular Specilists	Richmond	Virginia	United States	23226
60	Deaconess Medical Center	Spokane	Washington	United States	99204
61	University of Wisconsin	Madison	Wisconsin	United States	53792
62	St. Luke's Medical Center - Milwaukee	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Jon Matsumura, MD, University of Wisconsin, Madison
• Principal Investigator: Kenneth Rosenfield, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00106938
• Other Study ID Numbers: AVD-640-0052
• First Posted: Apr 4, 2005
• Last Update Posted: Jul 19, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Abbott Medical Devices: Carotid stenting; Carotid endarterectomy; Carotid artery disease with severe narrowing of the artery; Stroke prevention
• Additional relevant MeSH terms: Carotid Stenosis; Carotid Artery Diseases; Atherosclerosis

Study Results

Participant Flow

Recruitment Details	Asymptomatic subjects with extracranial internal carotid stenosis which was ≥70% & ≤99% by duplex ultrasound or ≥70% & ≤99% by angiography (visual estimate) with or without involvement of the contiguous common carotid artery, who could undergo carotid artery stenting/carotid endarterectomy and all follow-ups, were recruited starting from April 2005
Pre-assignment Detail	1453 patients were randomized to support the primary analysis; an additional 210 lead-in subjects were enrolled to allow investigators to gain experience with the study devices prior to randomizing subjects and were not part of the primary analysis.

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	1089	364
COMPLETED	913	293
NOT COMPLETED	176	71

Baseline Characteristics

Arm/Group Title	CAS Group	CEA Group	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	1089	364	1453
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	325 29.8%	103 28.3%	428 29.5%
>=65 years	764 70.2%	261 71.7%	1025 70.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.7 (7.0)	67.9 (6.9)	67.7 (7.0)
Sex: Female, Male (Count of Participants)
Female	423 38.8%	157 43.1%	580 39.9%
Male	666 61.2%	207 56.9%	873 60.1%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	985 90.4%	327 89.8%	1312 90.3%
Hispanic or Latino	38 3.5%	12 3.3%	50 3.4%
Pacific Islander	0 0%	1 0.3%	1 0.1%
Black or African American	45 4.1%	16 4.4%	61 4.2%
American Indian or Alaska	1 0.1%	0 0%	1 0.1%
Asian	10 0.9%	4 1.1%	14 1%
Other	10 0.9%	4 1.1%	14 1%
Region of Enrollment (participants) [Number]
United States	1089 100%	364 100%	1453 100%

Outcome Measures

1. Primary Outcome

Title	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.
Time Frame	0 to 365 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of participants]	3.8 0.3%	3.4 0.9%

2. Secondary Outcome

Title	Acute Device Success: Xact Carotid Stent
Description	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.
Time Frame	On day 0 after index procedure

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAS Group
Arm/Group Description	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.
Measure Participants	1025
Measure devices	1049
Number (95% Confidence Interval) [percentage of devices]	96.9

3. Secondary Outcome

Title	Acute Device Success: Embolic Protection Device System
Description	Defined as successful deployment and retrieval of the filter in the absence of angiographic distal embolization.
Time Frame	On day 0 after index procedure

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CAS Group
Arm/Group Description	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.
Measure Participants	1022
Measure Devices	1045
Mean (95% Confidence Interval) [Percentage of devices]	97.8

4. Secondary Outcome

Title	Procedural Success
Description	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.
Time Frame	0 to 30 days post procedure

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CAS Group
Arm/Group Description	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.
Measure Participants	1025
Number [percentage of participants]	95.6 8.8%

5. Secondary Outcome

Title	Composite Morbidity Measure
Description	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.
Time Frame	0 to 30 Days Post-procedure

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) population

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Composite morbidity measure	31 2.8%	17 4.7%
Cranial nerve injury	1 0.1%	4 1.1%
Peripheral nerve injury	0.0 0%	0.0 0%
Vascular injury	8 0.7%	3 0.8%
Non-cerebral bleeding	21 1.9%	6 1.6%
CEA wound or access artery wound	3 0.3%	4 1.1%
Other complications	0 0%	0 0%

6. Secondary Outcome

Title	Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)
Description	Freedom from CI-TLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time Frame	0 to 180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of partcipants]	99.8	99.7

7. Secondary Outcome

Title	Freedom From Clinically Indicated Target Lesion Revascularization
Description	Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time Frame	0 to 365 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of partcipants]	99.4	97.4

8. Secondary Outcome

Title	Freedom From Clinically Indicated Target Lesion Revascularization
Description	Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time Frame	0 to 730 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of partcipants]	98.7	96.7

9. Secondary Outcome

Title	Freedom From Clinically Indicated Target Lesion Revascularization
Description	Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time Frame	0 to 1095 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of partcipants]	98.4	96.7

10. Secondary Outcome

Title	Freedom From Clinically Indicated Target Lesion Revascularization
Description	Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time Frame	0 to 1460 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of partcipants]	98.4	96.7

11. Secondary Outcome

Title	Freedom From Clinically Indicated Target Lesion Revascularization
Description	Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time Frame	0 to 1825 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of partcipants]	98.4	96.7

12. Secondary Outcome

Title	Freedom From Ipsilateral Stroke
Description	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.
Time Frame	31 to 365 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1049	333
Number [percentage of participants]	99.4 9.1%	99.1 27.2%

13. Secondary Outcome

Title	Freedom From Ipsilateral Stroke
Description	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.
Time Frame	31 to 730 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1049	333
Number [percentage of participants]	99.0 9.1%	98.7 27.1%

14. Secondary Outcome

Title	Freedom From Ipsilateral Stroke
Description	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.
Time Frame	31 to 1095 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1049	333
Number [percentage of participants]	98.4 9%	97.8 26.9%

15. Secondary Outcome

Title	Freedom From Ipsilateral Stroke
Description	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.
Time Frame	31 to 1460 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1049	333
Number [percentage of participants]	97.8 9%	97.3 26.7%

16. Secondary Outcome

Title	Freedom From Ipsilateral Stroke
Description	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.
Time Frame	31 to 1825 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1049	333
Number [percentage of participants]	97.8 9%	97.3 26.7%

17. Secondary Outcome

Title	Freedom From Mortality
Time Frame	0 to 365 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of participants]	98.5 9%	99.1 27.2%

18. Secondary Outcome

Title	Freedom From Mortality
Time Frame	0 to 730 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of participants]	96.2 8.8%	98.4 27%

19. Secondary Outcome

Title	Freedom From Mortality
Time Frame	0 to 1095 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of partcipants]	94.3	97.5

20. Secondary Outcome

Title	Freedom From Mortality
Time Frame	0 to 1460 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of participants]	91.5 8.4%	93.7 25.7%

21. Secondary Outcome

Title	Freedom From Mortality
Time Frame	0 to 1825 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of participants]	87.1 8%	89.4 24.6%

22. Secondary Outcome

Title	Freedom From All Stroke
Time Frame	0 to 365 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of participants]	96.5 8.9%	97.7 26.8%

23. Secondary Outcome

Title	Freedom From All Stroke
Time Frame	0 to 730 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of participants]	95.8 8.8%	96.2 26.4%

24. Secondary Outcome

Title	Freedom From All Stroke
Time Frame	0 to 1095 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of participants]	94.5 8.7%	95.3 26.2%

25. Secondary Outcome

Title	Freedom From All Stroke
Time Frame	0 to 1460 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of participants]	93.8 8.6%	94.7 26%

26. Secondary Outcome

Title	Freedom From All Stroke
Time Frame	0 to 1825 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of participants]	93.1 8.5%	94.7 26%

27. Secondary Outcome

Title	Death (Non-Hierarchical)
Time Frame	≤ 30 Days Post Index Procedure

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1072	348
Number (95% Confidence Interval) [percentage of participants]	0.1 0%	0.3 0.1%

28. Secondary Outcome

Title	All Stroke (Non-Hierarchical)
Time Frame	≤ 30 Days Post Index Procedure

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1072	348
Number (95% Confidence Interval) [percentage of participants]	2.8 0.3%	1.4 0.4%

29. Secondary Outcome

Title	Myocardial Infarction (MI) (Non-Hierarchical)
Time Frame	≤ 30 Days Post Index Procedure

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1072	348
Number (95% Confidence Interval) [percentage of participants]	0.5 0%	0.9 0.2%

30. Secondary Outcome

Title	Death, Stroke or Myocardial Infarction (MI) (Hierarchical)
Time Frame	≤ 30 Days Post Index Procedure

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1072	348
Number (95% Confidence Interval) [percentage of participants]	3.3 0.3%	2.6 0.7%

31. Secondary Outcome

Title	Death or Stroke (Hierarchical)
Time Frame	≤ 30 Days Post Index Procedure

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1072	348
Number (95% Confidence Interval) [percentage of participants]	2.9 0.3%	1.7 0.5%

32. Secondary Outcome

Title	Death or Major Stroke (Hierarchical)
Time Frame	≤ 30 Days Post Index Procedure

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1072	348
Number (95% Confidence Interval) [percentage of participants]	0.6 0.1%	0.6 0.2%

33. Secondary Outcome

Title	Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years
Time Frame	0 to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description	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.	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.
Measure Participants	1089	364
Number [percentage of participants]	94.6 8.7%	94.8 26%

Adverse Events

Time Frame	1 year
Arm/Group Title	CAS Group		CEA Group
Arm/Group Description	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.		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.
All Cause Mortality
	CAS Group		CEA Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CAS Group		CEA Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	376/1089 (34.5%)		118/364 (32.4%)
Blood and lymphatic system disorders
Epistaxis	2/1089 (0.2%)	2	0/364 (0%)	0
GI bleed	15/1089 (1.4%)	15	8/364 (2.2%)	8
Genitourinary	2/1089 (0.2%)	2	0/364 (0%)	0
Vascular	0/1089 (0%)	0	2/364 (0.5%)	2
Anemia	13/1089 (1.2%)	15	3/364 (0.8%)	3
Cardiac disorders
Abnormal lab test	1/1089 (0.1%)	1	0/364 (0%)	0
Arrhythmia	22/1089 (2%)	25	4/364 (1.1%)	5
Cardiac arrest	5/1089 (0.5%)	5	3/364 (0.8%)	3
Congestive heart failure	10/1089 (0.9%)	12	1/364 (0.3%)	1
Coronary artery disease	57/1089 (5.2%)	70	21/364 (5.8%)	25
Pulmonary hypertension	2/1089 (0.2%)	2	0/364 (0%)	0
Structural heart disease	2/1089 (0.2%)	2	0/364 (0%)	0
Myocardial infarction	14/1089 (1.3%)	16	5/364 (1.4%)	5
Gastrointestinal disorders
Gastrointestinal	29/1089 (2.7%)	39	3/364 (0.8%)	3
General disorders
Genitourinary	25/1089 (2.3%)	28	1/364 (0.3%)	1
Miscellaneous	14/1089 (1.3%)	14	4/364 (1.1%)	6
Trauma	13/1089 (1.2%)	15	6/364 (1.6%)	6
Immune system disorders
Allergic reaction	2/1089 (0.2%)	2	0/364 (0%)	0
Infections and infestations
Infection	23/1089 (2.1%)	25	6/364 (1.6%)	6
Injury, poisoning and procedural complications
Bleeding	7/1089 (0.6%)	8	3/364 (0.8%)	3
Hematoma	4/1089 (0.4%)	4	3/364 (0.8%)	3
Infection	3/1089 (0.3%)	6	3/364 (0.8%)	3
Occlusion	2/1089 (0.2%)	2	0/364 (0%)	0
Pseudoaneurysm	1/1089 (0.1%)	1	0/364 (0%)	0
Vessel trauma	1/1089 (0.1%)	1	0/364 (0%)	0
Metabolism and nutrition disorders
Metabolic	10/1089 (0.9%)	10	1/364 (0.3%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal	41/1089 (3.8%)	45	7/364 (1.9%)	7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	21/1089 (1.9%)	23	8/364 (2.2%)	10
Nervous system disorders
Confusion	1/1089 (0.1%)	1	0/364 (0%)	0
Cranial nerve palsy	1/1089 (0.1%)	1	0/364 (0%)	0
Dizziness	1/1089 (0.1%)	1	3/364 (0.8%)	3
Encephalopathy	0/1089 (0%)	0	1/364 (0.3%)	1
Headache	1/1089 (0.1%)	1	0/364 (0%)	0
Hyperperfusion syndrome	1/1089 (0.1%)	1	0/364 (0%)	0
Neurologic other	13/1089 (1.2%)	13	3/364 (0.8%)	5
Peripheral neuropathy	1/1089 (0.1%)	1	0/364 (0%)	0
Seizure	5/1089 (0.5%)	7	1/364 (0.3%)	1
Subdural hematoma	2/1089 (0.2%)	2	0/364 (0%)	0
TIA	7/1089 (0.6%)	8	2/364 (0.5%)	2
Visual disturbance	3/1089 (0.3%)	3	0/364 (0%)	0
Ipsilateral major	7/1089 (0.6%)	7	1/364 (0.3%)	1
Ipsilateral minor	20/1089 (1.8%)	20	6/364 (1.6%)	6
Non-ipsilateral major	2/1089 (0.2%)	2	0/364 (0%)	0
Non-ipsilateral minor	3/1089 (0.3%)	3	0/364 (0%)	0
Psychiatric disorders
Mental health related	4/1089 (0.4%)	4	2/364 (0.5%)	3
Respiratory, thoracic and mediastinal disorders
Respiratory	19/1089 (1.7%)	24	9/364 (2.5%)	9
Surgical and medical procedures
Anesthesia/Procedural medication related	0/1089 (0%)	0	2/364 (0.5%)	2
Arrhythmia	17/1089 (1.6%)	18	3/364 (0.8%)	3
Bleeding	11/1089 (1%)	11	0/364 (0%)	0
Cranial nerve injury	2/1089 (0.2%)	2	3/364 (0.8%)	3
Fluid overload	1/1089 (0.1%)	1	0/364 (0%)	0
Headache	0/1089 (0%)	0	1/364 (0.3%)	1
Heparin induced thrombocytopenia	1/1089 (0.1%)	1	0/364 (0%)	0
Hypertension	5/1089 (0.5%)	6	7/364 (1.9%)	7
Hypotension	69/1089 (6.3%)	69	7/364 (1.9%)	7
Spasm	1/1089 (0.1%)	1	0/364 (0%)	0
Urinary retention	1/1089 (0.1%)	1	2/364 (0.5%)	2
Vessel trauma	7/1089 (0.6%)	7	0/364 (0%)	0
Vascular disorders
Hypertension	6/1089 (0.6%)	6	2/364 (0.5%)	2
Hypotension	7/1089 (0.6%)	8	1/364 (0.3%)	1
Syncope	4/1089 (0.4%)	4	1/364 (0.3%)	1
Abdominal Aortic Aneurysm	2/1089 (0.2%)	2	2/364 (0.5%)	2
Carotid artery disease	1/1089 (0.1%)	1	0/364 (0%)	0
Contralateral stenosis	7/1089 (0.6%)	7	3/364 (0.8%)	3
Deep vein thrombosis	0/1089 (0%)	0	1/364 (0.3%)	1
Occlusion	1/1089 (0.1%)	1	0/364 (0%)	0
Peripheral vascular disease	41/1089 (3.8%)	56	11/364 (3%)	20
Pulmonary embolism	1/1089 (0.1%)	1	0/364 (0%)	0
Renal artery disease	10/1089 (0.9%)	10	1/364 (0.3%)	1
Restenosis	1/1089 (0.1%)	1	0/364 (0%)	0
Stenosis	3/1089 (0.3%)	3	1/364 (0.3%)	1
Target lesion restenosis	8/1089 (0.7%)	8	9/364 (2.5%)	10
Other (Not Including Serious) Adverse Events
	CAS Group		CEA Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	635/1089 (58.3%)		216/364 (59.3%)
Gastrointestinal disorders
Other	93/1089 (8.5%)	115	33/364 (9.1%)	41
General disorders
Other	107/1089 (9.8%)	140	40/364 (11%)	47
Infections and infestations
Other	81/1089 (7.4%)	92	23/364 (6.3%)	31
Injury, poisoning and procedural complications
Anesthesia/Procedural medication related	65/1089 (6%)	70	51/364 (14%)	55
Arrhythmia	140/1089 (12.9%)	148	20/364 (5.5%)	20
Cranial nerve injury	14/1089 (1.3%)	15	48/364 (13.2%)	51
Headache	73/1089 (6.7%)	74	30/364 (8.2%)	31
Hypertension	40/1089 (3.7%)	40	29/364 (8%)	29
Hypotension	252/1089 (23.1%)	268	35/364 (9.6%)	36
Pain	56/1089 (5.1%)	60	64/364 (17.6%)	66
Metabolism and nutrition disorders
Other	51/1089 (4.7%)	58	24/364 (6.6%)	25
Musculoskeletal and connective tissue disorders
Other	173/1089 (15.9%)	211	28/364 (7.7%)	36
Respiratory, thoracic and mediastinal disorders
Other	56/1089 (5.1%)	66	18/364 (4.9%)	20

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.