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)

• ClinicalTrials.gov Identifier: NCT00106938
• Recruitment Status: Terminated
• First Posted: April 4, 2005
• Results First Posted: October 21, 2014
• Last Update Posted: July 19, 2017
• Sponsor: Abbott Medical Devices
• 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

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 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
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 Number of Baseline Participants		1089	364	1453
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

Outcome Measures

1. Primary Outcome

Title	Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days.
Description	[Not Specified]
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.
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
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.
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
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.
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
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.
Overall Number of Participants Analyzed	1025
Measure Type: Number; Unit of Measure: percentage of participants
	95.6

5. Secondary Outcome

Title	Composite Morbidity Measure
Description	A pre-specified composite Morbidity Measure (CMM) of cranial and peripheral nerve injury, vascular injury, non-cerebral bleeding, wound complications related to the neck incision or femoral puncture site, and other complications (anesthetic) at 30 days post-procedure.
Time Frame	0 to 30 Days Post-procedure

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) population

Arm/Group Title	CAS Group	CEA Group
Arm/Group Description:	CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.	CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
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)
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
Description	[Not Specified]
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.
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
Description	[Not Specified]
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.
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
Description	[Not Specified]
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.
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
Description	[Not Specified]
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.
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
Description	[Not Specified]
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.
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
Description	[Not Specified]
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.
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
Description	[Not Specified]
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.
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
Description	[Not Specified]
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.
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
Description	[Not Specified]
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.
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
Description	[Not Specified]
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.
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)
Description	[Not Specified]
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.
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)
Description	[Not Specified]
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.
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)
Description	[Not Specified]
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.
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)
Description	[Not Specified]
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.
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)
Description	[Not Specified]
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.
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)
Description	[Not Specified]
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.
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
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1089	364
Measure Type: Number; Unit of Measure: percentage of participants
	94.6	94.8

Adverse Events

Time Frame	1 year
Adverse Event Reporting 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.
All-Cause Mortality
	CAS Group		CEA Group
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
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)
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)

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: jennifer.jones@av.abbott.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Rosenfield K, Matsumura JS, Chaturvedi S, Riles T, Ansel GM, Metzger DC, Wechsler L, Jaff MR, Gray W; ACT I Investigators. Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis. N Engl J Med. 2016 Mar 17;374(11):1011-20. doi: 10.1056/NEJMoa1515706. Epub 2016 Feb 17.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00106938
• 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