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 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 |
---|---|---|
|
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
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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Freedom From Mortality [0 to 365 days]
- Freedom From Mortality [0 to 730 days]
- Freedom From Mortality [0 to 1095 days]
- Freedom From Mortality [0 to 1460 days]
- Freedom From Mortality [0 to 1825 days]
- Freedom From All Stroke [0 to 365 days]
- Freedom From All Stroke [0 to 730 days]
- Freedom From All Stroke [0 to 1095 days]
- Freedom From All Stroke [0 to 1460 days]
- Freedom From All Stroke [0 to 1825 days]
- Death (Non-Hierarchical) [≤ 30 Days Post Index Procedure]
- All Stroke (Non-Hierarchical) [≤ 30 Days Post Index Procedure]
- Myocardial Infarction (MI) (Non-Hierarchical) [≤ 30 Days Post Index Procedure]
- Death, Stroke or Myocardial Infarction (MI) (Hierarchical) [≤ 30 Days Post Index Procedure]
- Death or Stroke (Hierarchical) [≤ 30 Days Post Index Procedure]
- Death or Major Stroke (Hierarchical) [≤ 30 Days Post Index Procedure]
- 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
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:
-
Two or more proximal diseased coronary arteries of > 70% stenosis that have not or cannot be revascularized or < 30 days since revascularization.
-
Ejection fraction < 30% or New York Heart Association (NYHA) heart failure functional class 3 or higher.
-
Unstable angina, defined as angina at rest with ECG changes.
-
On a list for major organ transplant or is being evaluated for such.
-
Known history of respiratory insufficiency, forced expiratory volume (FEV1) < 30% (predicted).
-
Chronic renal insufficiency (serum creatinine >2.5 mg/dL).
-
Uncontrolled diabetes defined as fasting glucose > 400 mg/dL.
-
Concurrent requirement for any invasive procedure 30 days pre- or post-procedure.
-
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.
-
Subject has had radiation treatment to the neck.
-
Subject has had a radical neck dissection.
-
Surgically inaccessible lesions (i.e., lesions extending above the level of C2).
-
Spinal immobility - inability to flex neck beyond neutral or kyphotic deformity.
-
Presence of carotid artery dissection, aneurysm, pseudoaneurysm, arteritis or fibromuscular dysplasia (FMD) in the target vessel.
-
Hemodynamically significant (>60%) stenosis of the right or left common carotid artery (LCCA/RCCA) below the clavicle.
-
Presence of tracheostomy stoma.
-
Contralateral laryngeal nerve paralysis.
-
Previous carotid endarterectomy, extracranial-intracranial or carotid subclavian bypass procedure ipsilateral to the carotid stenosis.
-
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).
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.- AVD-640-0052
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
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. |
---|---|
Description | |
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%
|
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
|
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
|
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%
|
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%
|
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
|
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
|
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
|
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
|
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
|
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
|
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%
|
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%
|
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%
|
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%
|
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%
|
Title | Freedom From Mortality |
---|---|
Description | |
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%
|
Title | Freedom From Mortality |
---|---|
Description | |
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%
|
Title | Freedom From Mortality |
---|---|
Description | |
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
|
Title | Freedom From Mortality |
---|---|
Description | |
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%
|
Title | Freedom From Mortality |
---|---|
Description | |
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%
|
Title | Freedom From All Stroke |
---|---|
Description | |
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%
|
Title | Freedom From All Stroke |
---|---|
Description | |
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%
|
Title | Freedom From All Stroke |
---|---|
Description | |
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%
|
Title | Freedom From All Stroke |
---|---|
Description | |
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%
|
Title | Freedom From All Stroke |
---|---|
Description | |
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%
|
Title | Death (Non-Hierarchical) |
---|---|
Description | |
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%
|
Title | All Stroke (Non-Hierarchical) |
---|---|
Description | |
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%
|
Title | Myocardial Infarction (MI) (Non-Hierarchical) |
---|---|
Description | |
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%
|
Title | Death, Stroke or Myocardial Infarction (MI) (Hierarchical) |
---|---|
Description | |
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%
|
Title | Death or Stroke (Hierarchical) |
---|---|
Description | |
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%
|
Title | Death or Major Stroke (Hierarchical) |
---|---|
Description | |
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%
|
Title | Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years |
---|---|
Description | |
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 | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
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
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.
Results Point of Contact
Name/Title | Jennifer M Jones-McMeans, PhD (Associate Director Clinical Research) |
---|---|
Organization | Abbott Vascular |
Phone | 408-845-1459 |
jennifer.jones@av.abbott.com |
- AVD-640-0052