Amaurosis Fugax, Carotid Artery Disease, Stroke, Transient Ischemic Attack (TIA)
Conditions
Keywords
Carotid, Stent, Carotid Endarterectomy
Brief summary
The objective of the CANOPY trial is to assess the continued safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in subjects at standard risk for adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of carotid stenting experience.
Interventions
DEVICERX Acculink Carotid Stent System (RX Acculink)
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be ≥ 18 years of age. 2. Subject does not have any condition that limits their anticipated survival to less than 3 years. 3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. 4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR- 5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. 6. Subject with all the following target vessel characteristics: 1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 2. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery. 3. Absence of excessive vessel tortuosity that would impede delivery of devices. 7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure.
Exclusion criteria
1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA). 2. Subject with Hgb \<10.g/dl or platelet count \< 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) \> 1.5. 3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. 4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. 5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days) | 0 to 365 days |
| Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days | 365 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status | 365 days | — |
| Composite of Peri-procedural Death and Stroke by Age | 30 days | — |
| Death and All Stroke | 30 Days | — |
| Freedom From Clinically Driven Target Lesion Revascularization | 30 days | Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis \>50% in the stented lesion, or is asymptomatic and has a stenosis of \>80% in the stented lesion. |
| Clinical Success | 30 days | Clinical success is defined as the attainment of \< 50% residual stenosis of the target lesion and absence of a death or stroke 30-day post-procedure. |
| Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age | 365 days | — |
| Composite of Peri-procedural Death and Stroke by Symptomatic Status | 30 days | — |
Countries
United States
Participant flow
Recruitment details
Enrollment for the CANOPY clinical trial started on October 11, 2011 and was completed on September 12, 2013. The enrollment goal (1200 subjects) was reached with a total of 1203 subjects enrolled at 97 clinical sites.
Pre-assignment details
3/1203 subjects who received a non-study stent, were excluded from the analysis. A total of 1200 subjects were included in the primary analysis population (Full analysis set (FAS)).
Participants by arm
| Arm | Count |
|---|---|
| RX Acculink Carotid Stent System (RX Acculink) Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink. | 1,200 |
| Total | 1,200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 1-year Follow-up | Death | 30 |
| 1-year Follow-up | Lost to Follow-up | 2 |
| 1-year Follow-up | Missed visit | 29 |
| 1-year Follow-up | Physician Decision | 2 |
| 1-year Follow-up | Received a non-study stent | 2 |
| 1-year Follow-up | Withdrawal by Subject | 12 |
| 30-day Follow-up | Death | 3 |
| 30-day Follow-up | Missed visit | 23 |
| 30-day Follow-up | Physician Decision | 3 |
| 30-day Follow-up | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | RX Acculink Carotid Stent System (RX Acculink) |
|---|---|
| Age, Continuous | 69.52 years STANDARD_DEVIATION 8.46 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 10 participants |
| Race/Ethnicity, Customized Asian | 14 participants |
| Race/Ethnicity, Customized Black or African Heritage | 69 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 30 participants |
| Race/Ethnicity, Customized Information not available | 3 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 participants |
| Race/Ethnicity, Customized Refused to answer | 3 participants |
| Race/Ethnicity, Customized White | 1083 participants |
| Region of Enrollment United States | 1200 participants |
| Sex: Female, Male Female | 491 Participants |
| Sex: Female, Male Male | 709 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 619 / 1,200 |
| serious Total, serious adverse events | 266 / 1,200 |
Outcome results
Primary
Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days)
Time frame: 0 to 365 days
Population: FAS population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days) | 4.4 percentage of participants | Standard Error 0.6 |
Primary
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days
Time frame: 365 days
Population: FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days | 95.6 percentage of participants |
Secondary
Clinical Success
Clinical success is defined as the attainment of \< 50% residual stenosis of the target lesion and absence of a death or stroke 30-day post-procedure.
Time frame: 30 days
Population: FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Clinical Success | 96.4 percentage of participants |
Secondary
Composite of Peri-procedural Death and Stroke by Age
Time frame: 30 days
Population: FAS population. The number of participants analyzed includes subjects with data available at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Composite of Peri-procedural Death and Stroke by Age | 3.4 percentage of participants |
| Composite of Peri-procedural DS in the Asymptomatic Group | Composite of Peri-procedural Death and Stroke by Age | 3.4 percentage of participants |
Secondary
Composite of Peri-procedural Death and Stroke by Symptomatic Status
Time frame: 30 days
Population: FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Composite of Peri-procedural Death and Stroke by Symptomatic Status | 5.8 percentage of participants |
| Composite of Peri-procedural DS in the Asymptomatic Group | Composite of Peri-procedural Death and Stroke by Symptomatic Status | 2.5 percentage of participants |
Secondary
Death and All Stroke
Time frame: 30 Days
Population: FAS population. The number of participants analyzed includes subjects with data available at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Death and All Stroke | 3.4 percentage of participants |
Secondary
Freedom From Clinically Driven Target Lesion Revascularization
Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis \>50% in the stented lesion, or is asymptomatic and has a stenosis of \>80% in the stented lesion.
Time frame: 365 days
Population: FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Freedom From Clinically Driven Target Lesion Revascularization | 99.3 percentage of participants |
Secondary
Freedom From Clinically Driven Target Lesion Revascularization
Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis \>50% in the stented lesion, or is asymptomatic and has a stenosis of \>80% in the stented lesion.
Time frame: 30 days
Population: FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Freedom From Clinically Driven Target Lesion Revascularization | 99.9 percentage of participants |
Secondary
Freedom From Clinically Driven Target Lesion Revascularization
Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis \>50% in the stented lesion, or is asymptomatic and has a stenosis of \>80% in the stented lesion.
Time frame: 180 days
Population: FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Freedom From Clinically Driven Target Lesion Revascularization | 99.7 percentage of participants |
Secondary
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age
Time frame: 365 days
Population: FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age | 93.8 percentage of participants |
| Composite of Peri-procedural DS in the Asymptomatic Group | Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age | 95.8 percentage of participants |
Secondary
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status
Time frame: 365 days
Population: FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status | 92.5 percentage of participants |
| Composite of Peri-procedural DS in the Asymptomatic Group | Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status | 96.8 percentage of participants |