Atherosclerosis, Carotid Artery Disease, Carotid Stenosis, Stroke
Conditions
Keywords
Carotid stenting, Carotid endarterectomy, Carotid artery disease with severe narrowing of the artery, Stroke prevention
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.
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.
Interventions
Carotid artery stenting with filter (interventional)
PROCEDURECarotid artery endarterectomy (surgical)
Carotid artery endarterectomy (surgical)
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. The subject must be \> 18 and \< 80 years of age. 2. Female subjects of child bearing potential must have a documented negative pregnancy test within 30 days prior to the study procedure. 3. Subject must be asymptomatic, defined as no stroke or Transient Ischemic Attack \[(TIA);(hemispheric or ocular)\] within the 180 days prior to the procedure. Subjects who have experienced these neurological symptoms prior to the 180 day pre-procedure window will be eligible for enrollment. An independent study neurologist or independent study neurosurgeon must confirm the subject's neurological status. 4. Subjects taking warfarin may be included if their dosage is reduced before the procedure to result in an International Normalized Ratio (INR) of 1.5 or less. Warfarin may be restarted after the procedure. 5. The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local institutional review board (IRB). 6. The subject must agree to return for all required follow-up visits. 7. Subject has a discrete lesion located in the internal carotid artery (ICA); the contiguous common carotid artery (CCA) may be involved. 8. Carotid stenosis ≥ 70% and ≤ 99% by carotid ultrasound or ≥ 70% and ≤ 99% stenosis (visual estimate) by angiography, without significant (\> 60% by ultrasound or angiography) ICA/CCA contralateral stenosis. 9. Target ICA vessel diameter must be visually estimated to be: \> 2.5 mm and \< 7.0 for the Emboshield Pro or for the Emboshield NAV6, \> 2.8 mm and \< 6.2 for the Emboshield Gen 3 And \> 4.0 mm and \< 9.0 mm for the Xact stent treatment segment. An untreated contralateral ICA may be used for visual estimation when a highly stenosed lesion makes measurement of the target vessel inaccurate. 10. Based on the subject's anatomy, the Investigator should expect to successfully deliver the stent to the target lesion (absence of extreme tortuosity, etc.). 11. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days. | 0 to 365 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years | 0 to 5 years | — |
| 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. |
| Death or Major Stroke (Hierarchical) | ≤ 30 Days Post Index Procedure | — |
| Freedom From Mortality | 0 to 365 days | — |
| Freedom From All Stroke | 0 to 365 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 | — |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| CAS Group CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years. | 1,089 |
| CEA Group CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).
Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years. | 364 |
| Total | 1,453 |
Baseline characteristics
| Characteristic | CAS Group | CEA Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 764 Participants | 261 Participants | 1025 Participants |
| Age, Categorical Between 18 and 65 years | 325 Participants | 103 Participants | 428 Participants |
| Age, Continuous | 67.7 years STANDARD_DEVIATION 7 | 67.9 years STANDARD_DEVIATION 6.9 | 67.7 years STANDARD_DEVIATION 7 |
| Race/Ethnicity, Customized American Indian or Alaska | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 10 participants | 4 participants | 14 participants |
| Race/Ethnicity, Customized Black or African American | 45 participants | 16 participants | 61 participants |
| Race/Ethnicity, Customized Caucasian | 985 participants | 327 participants | 1312 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 38 participants | 12 participants | 50 participants |
| Race/Ethnicity, Customized Other | 10 participants | 4 participants | 14 participants |
| Race/Ethnicity, Customized Pacific Islander | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 1089 participants | 364 participants | 1453 participants |
| Sex: Female, Male Female | 423 Participants | 157 Participants | 580 Participants |
| Sex: Female, Male Male | 666 Participants | 207 Participants | 873 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 635 / 1,089 | 216 / 364 |
| serious Total, serious adverse events | 376 / 1,089 | 118 / 364 |
Outcome results
Primary
Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days.
Time frame: 0 to 365 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | 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. | 3.8 percentage of participants |
| CEA Group | 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. | 3.4 percentage of participants |
Secondary
Acute Device Success: Embolic Protection Device System
Defined as successful deployment and retrieval of the filter in the absence of angiographic distal embolization.
Time frame: On day 0 after index procedure
Population: Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CAS Group | Acute Device Success: Embolic Protection Device System | 97.8 Percentage of devices |
Secondary
Acute Device Success: Xact Carotid Stent
Defined as attainment of final residual diameter stenosis of \< 50% by Qualitative Comparative Analysis (QCA) (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.
Time frame: On day 0 after index procedure
Population: Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Acute Device Success: Xact Carotid Stent | 96.9 percentage of devices |
Secondary
All Stroke (Non-Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | All Stroke (Non-Hierarchical) | 2.8 percentage of participants |
| CEA Group | All Stroke (Non-Hierarchical) | 1.4 percentage of participants |
Secondary
Composite Morbidity Measure
A pre-specified composite Morbidity Measure (CMM) of cranial and peripheral nerve injury, vascular injury, non-cerebral bleeding, wound complications related to the neck incision or femoral puncture site, and other complications (anesthetic) at 30 days post-procedure.
Time frame: 0 to 30 Days Post-procedure
Population: Intent-to-Treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAS Group | Composite Morbidity Measure | Peripheral nerve injury | 0.0 participants |
| CAS Group | Composite Morbidity Measure | Non-cerebral bleeding | 21 participants |
| CAS Group | Composite Morbidity Measure | Cranial nerve injury | 1 participants |
| CAS Group | Composite Morbidity Measure | CEA wound or access artery wound | 3 participants |
| CAS Group | Composite Morbidity Measure | Vascular injury | 8 participants |
| CAS Group | Composite Morbidity Measure | Other complications | 0 participants |
| CAS Group | Composite Morbidity Measure | Composite morbidity measure | 31 participants |
| CEA Group | Composite Morbidity Measure | Other complications | 0 participants |
| CEA Group | Composite Morbidity Measure | Composite morbidity measure | 17 participants |
| CEA Group | Composite Morbidity Measure | Cranial nerve injury | 4 participants |
| CEA Group | Composite Morbidity Measure | Peripheral nerve injury | 0.0 participants |
| CEA Group | Composite Morbidity Measure | Vascular injury | 3 participants |
| CEA Group | Composite Morbidity Measure | Non-cerebral bleeding | 6 participants |
| CEA Group | Composite Morbidity Measure | CEA wound or access artery wound | 4 participants |
Secondary
Death (Non-Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Death (Non-Hierarchical) | 0.1 percentage of participants |
| CEA Group | Death (Non-Hierarchical) | 0.3 percentage of participants |
Secondary
Death or Major Stroke (Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Death or Major Stroke (Hierarchical) | 0.6 percentage of participants |
| CEA Group | Death or Major Stroke (Hierarchical) | 0.6 percentage of participants |
Secondary
Death or Stroke (Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Death or Stroke (Hierarchical) | 2.9 percentage of participants |
| CEA Group | Death or Stroke (Hierarchical) | 1.7 percentage of participants |
Secondary
Death, Stroke or Myocardial Infarction (MI) (Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Death, Stroke or Myocardial Infarction (MI) (Hierarchical) | 3.3 percentage of participants |
| CEA Group | Death, Stroke or Myocardial Infarction (MI) (Hierarchical) | 2.6 percentage of participants |
Secondary
Freedom From All Stroke
Time frame: 0 to 365 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From All Stroke | 96.5 percentage of participants |
| CEA Group | Freedom From All Stroke | 97.7 percentage of participants |
Secondary
Freedom From All Stroke
Time frame: 0 to 730 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From All Stroke | 95.8 percentage of participants |
| CEA Group | Freedom From All Stroke | 96.2 percentage of participants |
Secondary
Freedom From All Stroke
Time frame: 0 to 1095 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From All Stroke | 94.5 percentage of participants |
| CEA Group | Freedom From All Stroke | 95.3 percentage of participants |
Secondary
Freedom From All Stroke
Time frame: 0 to 1825 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From All Stroke | 93.1 percentage of participants |
| CEA Group | Freedom From All Stroke | 94.7 percentage of participants |
Secondary
Freedom From All Stroke
Time frame: 0 to 1460 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From All Stroke | 93.8 percentage of participants |
| CEA Group | Freedom From All Stroke | 94.7 percentage of participants |
Secondary
Freedom From Clinically Indicated Target Lesion Revascularization
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time frame: 0 to 365 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Clinically Indicated Target Lesion Revascularization | 99.4 percentage of partcipants |
| CEA Group | Freedom From Clinically Indicated Target Lesion Revascularization | 97.4 percentage of partcipants |
Secondary
Freedom From Clinically Indicated Target Lesion Revascularization
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time frame: 0 to 1095 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Clinically Indicated Target Lesion Revascularization | 98.4 percentage of partcipants |
| CEA Group | Freedom From Clinically Indicated Target Lesion Revascularization | 96.7 percentage of partcipants |
Secondary
Freedom From Clinically Indicated Target Lesion Revascularization
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time frame: 0 to 1460 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Clinically Indicated Target Lesion Revascularization | 98.4 percentage of partcipants |
| CEA Group | Freedom From Clinically Indicated Target Lesion Revascularization | 96.7 percentage of partcipants |
Secondary
Freedom From Clinically Indicated Target Lesion Revascularization
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time frame: 0 to 1825 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Clinically Indicated Target Lesion Revascularization | 98.4 percentage of partcipants |
| CEA Group | Freedom From Clinically Indicated Target Lesion Revascularization | 96.7 percentage of partcipants |
Secondary
Freedom From Clinically Indicated Target Lesion Revascularization
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time frame: 0 to 730 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Clinically Indicated Target Lesion Revascularization | 98.7 percentage of partcipants |
| CEA Group | Freedom From Clinically Indicated Target Lesion Revascularization | 96.7 percentage of partcipants |
Secondary
Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)
Freedom from CI-TLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Time frame: 0 to 180 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR) | 99.8 percentage of partcipants |
| CEA Group | Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR) | 99.7 percentage of partcipants |
Secondary
Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years
Time frame: 0 to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years | 94.6 percentage of participants |
| CEA Group | Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years | 94.8 percentage of participants |
Secondary
Freedom From Ipsilateral Stroke
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Time frame: 31 to 1460 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Ipsilateral Stroke | 97.8 percentage of participants |
| CEA Group | Freedom From Ipsilateral Stroke | 97.3 percentage of participants |
Secondary
Freedom From Ipsilateral Stroke
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Time frame: 31 to 1095 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Ipsilateral Stroke | 98.4 percentage of participants |
| CEA Group | Freedom From Ipsilateral Stroke | 97.8 percentage of participants |
Secondary
Freedom From Ipsilateral Stroke
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Time frame: 31 to 365 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Ipsilateral Stroke | 99.4 percentage of participants |
| CEA Group | Freedom From Ipsilateral Stroke | 99.1 percentage of participants |
Secondary
Freedom From Ipsilateral Stroke
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Time frame: 31 to 730 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Ipsilateral Stroke | 99.0 percentage of participants |
| CEA Group | Freedom From Ipsilateral Stroke | 98.7 percentage of participants |
Secondary
Freedom From Ipsilateral Stroke
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Time frame: 31 to 1825 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Ipsilateral Stroke | 97.8 percentage of participants |
| CEA Group | Freedom From Ipsilateral Stroke | 97.3 percentage of participants |
Secondary
Freedom From Mortality
Time frame: 0 to 1095 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Mortality | 94.3 percentage of partcipants |
| CEA Group | Freedom From Mortality | 97.5 percentage of partcipants |
Secondary
Freedom From Mortality
Time frame: 0 to 1460 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Mortality | 91.5 percentage of participants |
| CEA Group | Freedom From Mortality | 93.7 percentage of participants |
Secondary
Freedom From Mortality
Time frame: 0 to 730 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Mortality | 96.2 percentage of participants |
| CEA Group | Freedom From Mortality | 98.4 percentage of participants |
Secondary
Freedom From Mortality
Time frame: 0 to 365 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Mortality | 98.5 percentage of participants |
| CEA Group | Freedom From Mortality | 99.1 percentage of participants |
Secondary
Freedom From Mortality
Time frame: 0 to 1825 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Freedom From Mortality | 87.1 percentage of participants |
| CEA Group | Freedom From Mortality | 89.4 percentage of participants |
Secondary
Myocardial Infarction (MI) (Non-Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Myocardial Infarction (MI) (Non-Hierarchical) | 0.5 percentage of participants |
| CEA Group | Myocardial Infarction (MI) (Non-Hierarchical) | 0.9 percentage of participants |
Secondary
Procedural Success
Procedural success is defined as the attainment of target lesion final residual diameter stenosis of \< 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days.
Time frame: 0 to 30 days post procedure
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| CAS Group | Procedural Success | 95.6 percentage of participants |