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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040012 S034/ PAS001 |
| Date Original Protocol Accepted |
05/06/2011
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| Date Current Protocol Accepted |
03/04/2016
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| Study Name |
CANOPY Trial
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| Device Name |
RX ACCULINK CAROTID STENT SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The study is a prospective, multi-center, non-randomized, single arm.
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| Study Population |
Patients with neurological symptoms 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 patients without neurological symptoms and > 70% stenosis of the common or internal carotid artery by ultrasound or > 60% stenosis of the common or internal carotid artery by angiogram.
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| Sample Size |
The trial will enroll a minimum of 1,200 subjects (336 symptomatic and 864 asymptomatic subjects) at up to 350 sites in the United Sates.
The overall trial sample size was determined based on the secondary endpoint of peri- procedural DS by symptomatic status and its comparison with the respective PG (Symptomatic subjects: n= 336, accounting for 22 subject lost to follow-up; Asymptomatic subjects: n= 864 subjects, accounting for 58 subject lost to follow-up).
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| Key Study Endpoints |
Primary Endpoint: A composite rate of peri-procedural (within 30 days of the procedure) DS, plus ipsilateral stroke between day 31 and 1 year (365 days)
Secondary Endpoints
1. Composite of peri-procedural DS by symptomatic status
2. Ipsilateral stroke at 2 years
3. Composite of peri-procedural DS plus ipsilateral stroke at 1 and 2 years for octogenarians
4. Annual rate of clinically driven target lesion revascularization (TLR) through 2 years
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| Follow-up Visits and Length of Follow-up |
2 years
Follow-up for all subjects will be performed at 24 hours post-procedure, 30 days, 1 year, and annually for a total of 2 years.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1203
Full Analysis Set population: 1196 subjects
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| Actual Number of Sites Enrolled |
97
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| Patient Follow-up Rate |
85.9 % at 2 years (based on the Full Analysis Set population)
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| Final Safety Findings |
Primary Endpoint
The study met the 12 month primary endpoint. The primary endpoint was the composite of death and Stroke (DS) within 30 days after the index procedure plus Ipsilateral Stroke rate between 31 days and 365 days. The primary endpoint rate for the overall patient population by Kaplan Meier (KM) analysis was 4.2% with upper one-sided 95% confidence interval (CI) of 5.15% which is less than the 8.4% performance goal (PG, p< 0.0001).
The freedom from death and stroke within 30 days and ipsilateral stroke between 31 days through 3 years in the overall population was 96.8% at 30 days, and 95.8%, 95.4% and 95.2% at 1, 2 and 3 years respectively.
Secondary Endpoints
Ipsilateral Stroke Rates
The freedom from ipsilateral stroke through 3 years by KM analysis was 97.5% at 30 days, 96.5% at 1 year, 96.1% at 2 years and 95.8% at 3 years. Majority of the ipsilateral strokes (63.8%, 30/47) occurred during the first 30 days and only 6 (12.8%) strokes occurred after 1 year.
Composite of Death and Stroke by Symptomatic Status
The composite of death and stroke rate at 30 days in the symptomatic group was 5.5% with upper one- sided 95% CI of 7.5% which is significantly less the 10.3% PG (p<0.0001). For the Asymptomatic group DS at 30 days was 2.3% with upper one-sided 95% CI of 3.19 % which is significantly less the 5.2 % PG (p<0.0001).
The freedom from death and stroke at 30 days and ipsilateral stroke at 1, 2 and 3 years was 92.9%, 92.6% and 91.9% respectively in the Symptomatic group and 96.9%, 96.5% and 96.4% respectively in the Asymptomatic group [Log Rank test p= 0.0020].
Composite of Death and Stroke by age
The death and stroke rate within 30 days for octogenarians (subjects = 80 years) was 3.4% and non- octogenarians (subjects < 80 years) was 3.2% [95% CI for the rate difference of -0.23 was -5.40% to 2.21%]. The freedom from death and stroke within 30 days plus ipsilateral stroke was 93.8% at 1, 2, and 3 years in octogenarians and 96.0%, 95.6%, and 95.3% at 1, 2 and 3 years respectively in non- octogenarian subjects [Log rank test, p =0.4486].
Clinically-driven target lesion revascularization (CD-TLR)
The freedom from clinically driven target lesion revascularization was 99.9% at 30 days, 99.3% at 1 year, 98.1% at 2 years and 97.5% at 3 years.
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| Study Strengths & Weaknesses |
The study met the primary endpoint and provided 2- year long term as well as available 3-year data. The 2 year follow-up compliance rate was adequate. This was a single-arm non randomized study that may not have the advantages of a randomized control trial. There were several protocol deviations reported and corrective actions were implemented where necessary.
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow–up visits etc.), final results and study strengths and limitations of the PAS.
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