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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) (ACT I)

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ClinicalTrials.gov Identifier: NCT00106938
Recruitment Status : Terminated (Business decision and not a result of any patient or product safety issues.)
First Posted : April 4, 2005
Results First Posted : October 21, 2014
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Carotid Artery Disease
Carotid Stenosis
Stroke
Atherosclerosis
Interventions Device: Carotid artery stenting with filter (interventional)
Procedure: Carotid artery endarterectomy (surgical)
Enrollment 1663
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 Details 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
Hide 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
Arm/Group Title CAS Group CEA Group Total
Hide 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 Number of Baseline Participants 1089 364 1453
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1089 participants 364 participants 1453 participants
<=18 years
0
   0.0%
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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1089 participants 364 participants 1453 participants
67.7  (7.0) 67.9  (6.9) 67.7  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1089 participants 364 participants 1453 participants
Female
423
  38.8%
157
  43.1%
580
  39.9%
Male
666
  61.2%
207
  56.9%
873
  60.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1089 participants 364 participants 1453 participants
Caucasian 985 327 1312
Hispanic or Latino 38 12 50
Pacific Islander 0 1 1
Black or African American 45 16 61
American Indian or Alaska 1 0 1
Asian 10 4 14
Other 10 4 14
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1089 participants 364 participants 1453 participants
1089 364 1453
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.
Hide Description [Not Specified]
Time Frame 0 to 365 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of participants
3.8 3.4
2.Secondary Outcome
Title Acute Device Success: Xact Carotid Stent
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 1025
Overall Number of Units Analyzed
Type of Units Analyzed: Devices
1049
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of devices
96.9
(95.6 to 97.8)
3.Secondary Outcome
Title Acute Device Success: Embolic Protection Device System
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 1022
Overall Number of Units Analyzed
Type of Units Analyzed: Devices
1045
Mean (95% Confidence Interval)
Unit of Measure: Percentage of devices
97.8
(96.7 to 98.6)
4.Secondary Outcome
Title Procedural Success
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 1025
Measure Type: Number
Unit of Measure: percentage of participants
95.6
5.Secondary Outcome
Title Composite Morbidity Measure
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: participants
Composite morbidity measure 31 17
Cranial nerve injury 1 4
Peripheral nerve injury 0.0 0.0
Vascular injury 8 3
Non-cerebral bleeding 21 6
CEA wound or access artery wound 3 4
Other complications 0 0
6.Secondary Outcome
Title Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of partcipants
99.8 99.7
7.Secondary Outcome
Title Freedom From Clinically Indicated Target Lesion Revascularization
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of partcipants
99.4 97.4
8.Secondary Outcome
Title Freedom From Clinically Indicated Target Lesion Revascularization
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of partcipants
98.7 96.7
9.Secondary Outcome
Title Freedom From Clinically Indicated Target Lesion Revascularization
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of partcipants
98.4 96.7
10.Secondary Outcome
Title Freedom From Clinically Indicated Target Lesion Revascularization
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of partcipants
98.4 96.7
11.Secondary Outcome
Title Freedom From Clinically Indicated Target Lesion Revascularization
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of partcipants
98.4 96.7
12.Secondary Outcome
Title Freedom From Ipsilateral Stroke
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1049 333
Measure Type: Number
Unit of Measure: percentage of participants
99.4 99.1
13.Secondary Outcome
Title Freedom From Ipsilateral Stroke
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1049 333
Measure Type: Number
Unit of Measure: percentage of participants
99.0 98.7
14.Secondary Outcome
Title Freedom From Ipsilateral Stroke
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1049 333
Measure Type: Number
Unit of Measure: percentage of participants
98.4 97.8
15.Secondary Outcome
Title Freedom From Ipsilateral Stroke
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1049 333
Measure Type: Number
Unit of Measure: percentage of participants
97.8 97.3
16.Secondary Outcome
Title Freedom From Ipsilateral Stroke
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1049 333
Measure Type: Number
Unit of Measure: percentage of participants
97.8 97.3
17.Secondary Outcome
Title Freedom From Mortality
Hide Description [Not Specified]
Time Frame 0 to 365 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of participants
98.5 99.1
18.Secondary Outcome
Title Freedom From Mortality
Hide Description [Not Specified]
Time Frame 0 to 730 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of participants
96.2 98.4
19.Secondary Outcome
Title Freedom From Mortality
Hide Description [Not Specified]
Time Frame 0 to 1095 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of partcipants
94.3 97.5
20.Secondary Outcome
Title Freedom From Mortality
Hide Description [Not Specified]
Time Frame 0 to 1460 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of participants
91.5 93.7
21.Secondary Outcome
Title Freedom From Mortality
Hide Description [Not Specified]
Time Frame 0 to 1825 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of participants
87.1 89.4
22.Secondary Outcome
Title Freedom From All Stroke
Hide Description [Not Specified]
Time Frame 0 to 365 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of participants
96.5 97.7
23.Secondary Outcome
Title Freedom From All Stroke
Hide Description [Not Specified]
Time Frame 0 to 730 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of participants
95.8 96.2
24.Secondary Outcome
Title Freedom From All Stroke
Hide Description [Not Specified]
Time Frame 0 to 1095 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of participants
94.5 95.3
25.Secondary Outcome
Title Freedom From All Stroke
Hide Description [Not Specified]
Time Frame 0 to 1460 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of participants
93.8 94.7
26.Secondary Outcome
Title Freedom From All Stroke
Hide Description [Not Specified]
Time Frame 0 to 1825 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of participants
93.1 94.7
27.Secondary Outcome
Title Death (Non-Hierarchical)
Hide Description [Not Specified]
Time Frame ≤ 30 Days Post Index Procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 1072 348
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.1
(0.0 to 0.5)
0.3
(0.0 to 1.6)
28.Secondary Outcome
Title All Stroke (Non-Hierarchical)
Hide Description [Not Specified]
Time Frame ≤ 30 Days Post Index Procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 1072 348
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.8
(1.9 to 4.0)
1.4
(0.5 to 3.3)
29.Secondary Outcome
Title Myocardial Infarction (MI) (Non-Hierarchical)
Hide Description [Not Specified]
Time Frame ≤ 30 Days Post Index Procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 1072 348
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.5
(0.2 to 1.1)
0.9
(0.2 to 2.5)
30.Secondary Outcome
Title Death, Stroke or Myocardial Infarction (MI) (Hierarchical)
Hide Description [Not Specified]
Time Frame ≤ 30 Days Post Index Procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 1072 348
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.3
(2.3 to 4.5)
2.6
(1.2 to 4.9)
31.Secondary Outcome
Title Death or Stroke (Hierarchical)
Hide Description [Not Specified]
Time Frame ≤ 30 Days Post Index Procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 1072 348
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.9
(2.0 to 4.1)
1.7
(0.6 to 3.7)
32.Secondary Outcome
Title Death or Major Stroke (Hierarchical)
Hide Description [Not Specified]
Time Frame ≤ 30 Days Post Index Procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 1072 348
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.6
(0.2 to 1.2)
0.6
(0.1 to 2.1)
33.Secondary Outcome
Title Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years
Hide Description [Not Specified]
Time Frame 0 to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAS Group CEA Group
Hide 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.

Overall Number of Participants Analyzed 1089 364
Measure Type: Number
Unit of Measure: percentage of participants
94.6 94.8
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CAS Group CEA Group
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CAS Group CEA Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   376/1089 (34.53%)      118/364 (32.42%)    
Blood and lymphatic system disorders     
Epistaxis  1  2/1089 (0.18%)  2 0/364 (0.00%)  0
GI bleed  1  15/1089 (1.38%)  15 8/364 (2.20%)  8
Genitourinary  1  2/1089 (0.18%)  2 0/364 (0.00%)  0
Vascular  1  0/1089 (0.00%)  0 2/364 (0.55%)  2
Anemia  1  13/1089 (1.19%)  15 3/364 (0.82%)  3
Cardiac disorders     
Abnormal lab test  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Arrhythmia  1  22/1089 (2.02%)  25 4/364 (1.10%)  5
Cardiac arrest  1  5/1089 (0.46%)  5 3/364 (0.82%)  3
Congestive heart failure  1  10/1089 (0.92%)  12 1/364 (0.27%)  1
Coronary artery disease  1  57/1089 (5.23%)  70 21/364 (5.77%)  25
Pulmonary hypertension  1  2/1089 (0.18%)  2 0/364 (0.00%)  0
Structural heart disease  1  2/1089 (0.18%)  2 0/364 (0.00%)  0
Myocardial infarction  1  14/1089 (1.29%)  16 5/364 (1.37%)  5
Gastrointestinal disorders     
Gastrointestinal  1  29/1089 (2.66%)  39 3/364 (0.82%)  3
General disorders     
Genitourinary  1  25/1089 (2.30%)  28 1/364 (0.27%)  1
Miscellaneous  1  14/1089 (1.29%)  14 4/364 (1.10%)  6
Trauma  1  13/1089 (1.19%)  15 6/364 (1.65%)  6
Immune system disorders     
Allergic reaction  1  2/1089 (0.18%)  2 0/364 (0.00%)  0
Infections and infestations     
Infection  1  23/1089 (2.11%)  25 6/364 (1.65%)  6
Injury, poisoning and procedural complications     
Bleeding  1  7/1089 (0.64%)  8 3/364 (0.82%)  3
Hematoma  1  4/1089 (0.37%)  4 3/364 (0.82%)  3
Infection  1  3/1089 (0.28%)  6 3/364 (0.82%)  3
Occlusion  1  2/1089 (0.18%)  2 0/364 (0.00%)  0
Pseudoaneurysm  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Vessel trauma  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Metabolism and nutrition disorders     
Metabolic  1  10/1089 (0.92%)  10 1/364 (0.27%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal  1  41/1089 (3.76%)  45 7/364 (1.92%)  7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer  1  21/1089 (1.93%)  23 8/364 (2.20%)  10
Nervous system disorders     
Confusion  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Cranial nerve palsy  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Dizziness  1  1/1089 (0.09%)  1 3/364 (0.82%)  3
Encephalopathy  1  0/1089 (0.00%)  0 1/364 (0.27%)  1
Headache  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Hyperperfusion syndrome  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Neurologic other  1  13/1089 (1.19%)  13 3/364 (0.82%)  5
Peripheral neuropathy  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Seizure  1  5/1089 (0.46%)  7 1/364 (0.27%)  1
Subdural hematoma  1  2/1089 (0.18%)  2 0/364 (0.00%)  0
TIA  1  7/1089 (0.64%)  8 2/364 (0.55%)  2
Visual disturbance  1  3/1089 (0.28%)  3 0/364 (0.00%)  0
Ipsilateral major  1  7/1089 (0.64%)  7 1/364 (0.27%)  1
Ipsilateral minor  1  20/1089 (1.84%)  20 6/364 (1.65%)  6
Non-ipsilateral major  1  2/1089 (0.18%)  2 0/364 (0.00%)  0
Non-ipsilateral minor  1  3/1089 (0.28%)  3 0/364 (0.00%)  0
Psychiatric disorders     
Mental health related  1  4/1089 (0.37%)  4 2/364 (0.55%)  3
Respiratory, thoracic and mediastinal disorders     
Respiratory  1  19/1089 (1.74%)  24 9/364 (2.47%)  9
Surgical and medical procedures     
Anesthesia/Procedural medication related  1  0/1089 (0.00%)  0 2/364 (0.55%)  2
Arrhythmia  1  17/1089 (1.56%)  18 3/364 (0.82%)  3
Bleeding  1  11/1089 (1.01%)  11 0/364 (0.00%)  0
Cranial nerve injury  1  2/1089 (0.18%)  2 3/364 (0.82%)  3
Fluid overload  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Headache  1  0/1089 (0.00%)  0 1/364 (0.27%)  1
Heparin induced thrombocytopenia  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Hypertension  1  5/1089 (0.46%)  6 7/364 (1.92%)  7
Hypotension  1  69/1089 (6.34%)  69 7/364 (1.92%)  7
Spasm  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Urinary retention  1  1/1089 (0.09%)  1 2/364 (0.55%)  2
Vessel trauma  1  7/1089 (0.64%)  7 0/364 (0.00%)  0
Vascular disorders     
Hypertension  1  6/1089 (0.55%)  6 2/364 (0.55%)  2
Hypotension  1  7/1089 (0.64%)  8 1/364 (0.27%)  1
Syncope  1  4/1089 (0.37%)  4 1/364 (0.27%)  1
Abdominal Aortic Aneurysm  1  2/1089 (0.18%)  2 2/364 (0.55%)  2
Carotid artery disease  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Contralateral stenosis  1  7/1089 (0.64%)  7 3/364 (0.82%)  3
Deep vein thrombosis  1  0/1089 (0.00%)  0 1/364 (0.27%)  1
Occlusion  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Peripheral vascular disease  1  41/1089 (3.76%)  56 11/364 (3.02%)  20
Pulmonary embolism  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Renal artery disease  1  10/1089 (0.92%)  10 1/364 (0.27%)  1
Restenosis  1  1/1089 (0.09%)  1 0/364 (0.00%)  0
Stenosis  1  3/1089 (0.28%)  3 1/364 (0.27%)  1
Target lesion restenosis  1  8/1089 (0.73%)  8 9/364 (2.47%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CAS Group CEA Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   635/1089 (58.31%)      216/364 (59.34%)    
Gastrointestinal disorders     
Other  1  93/1089 (8.54%)  115 33/364 (9.07%)  41
General disorders     
Other  1  107/1089 (9.83%)  140 40/364 (10.99%)  47
Infections and infestations     
Other  1  81/1089 (7.44%)  92 23/364 (6.32%)  31
Injury, poisoning and procedural complications     
Anesthesia/Procedural medication related  1  65/1089 (5.97%)  70 51/364 (14.01%)  55
Arrhythmia  1  140/1089 (12.86%)  148 20/364 (5.49%)  20
Cranial nerve injury  1  14/1089 (1.29%)  15 48/364 (13.19%)  51
Headache  1  73/1089 (6.70%)  74 30/364 (8.24%)  31
Hypertension  1  40/1089 (3.67%)  40 29/364 (7.97%)  29
Hypotension  1  252/1089 (23.14%)  268 35/364 (9.62%)  36
Pain  1  56/1089 (5.14%)  60 64/364 (17.58%)  66
Metabolism and nutrition disorders     
Other  1  51/1089 (4.68%)  58 24/364 (6.59%)  25
Musculoskeletal and connective tissue disorders     
Other  1  173/1089 (15.89%)  211 28/364 (7.69%)  36
Respiratory, thoracic and mediastinal disorders     
Other  1  56/1089 (5.14%)  66 18/364 (4.95%)  20
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jennifer M Jones-McMeans, PhD (Associate Director Clinical Research)
Organization: Abbott Vascular
Phone: 408-845-1459
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00106938     History of Changes
Other Study ID Numbers: AVD-640-0052
First Submitted: April 1, 2005
First Posted: April 4, 2005
Results First Submitted: April 2, 2014
Results First Posted: October 21, 2014
Last Update Posted: July 19, 2017