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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140026 S016/ PAS001 |
| Date Original Protocol Accepted |
04/28/2022
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| Date Current Protocol Accepted |
07/20/2023
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| Study Name |
ROADSTER 3 PAS
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| Device Name |
ENROUTE Transcarotid Stent System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Transit.Adolescent A (distinctively):18 yrs<22 yrs,
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Open label, single arm, multicenter study; To evaluate real world usage of the ENROUTE Transcarotid Stent System (ENROUTE TSS) when used in conjunction with the ENROUTE Transcarotid Neuroprotection System (ENROUTE NPS) in patients at standard risk for adverse events from carotid endarterectomy (CEA).
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| Study Population |
Patients at standard risk for complications from CEA with atherosclerotic
extracranial internal carotid artery (ICA) stenosis with or without involvement of the contiguous common artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography. Patients must meet one of the following criteria regarding neurological symptom status and degree of stenosis:
Symptomatic (greater than or equal to 70% stenosis of the common or internal carotid artery by ultrasound or greater than or equal to 50% stenosis of the common or internal carotid artery by angiogram), OR
Asymptomatic (greater than or equal to 70% stenosis of the common or internal carotid artery by ultrasound or greater than or equal to 60% stenosis of the common or internal carotid artery by angiogram)
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| Sample Size |
No. of subjects: A maximum of 400 patients treated per protocol.
No. of sites: A minimum of 30 and up to a maximum of 60 sites.
Sites location: US
Assumptions for Sample Size Estimation:
Primary Endpoint
Assumed Incidence – 4%
Priori threshold – 8%
Power – 80%
Nominal alpha – 2.5%
Calculated sample size is 315
Key Secondary Endpoint
Incidence of cranial nerve injury within 30 days of the index procedure
Assumed incidence – 0.5%
Priori threshold – 2.7% (reported from VQI standard risk patients, )
Nominal alpha -2.5%
Power -80%
Calculated Sample size is 300
The testing strategy is to reject 2.7% with 97.5% confidence
To account for the larger of the 2 calculated sample sizes, a maximum of 400 patients will be enrolled.
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| Key Study Endpoints |
Safety Endpoints
Primary:
Hierarchical composite of Major Adverse Events (MAEs) defined as any death, stroke, or myocardial infarction (MI) within 30 days of the index procedure and ipsilateral stroke within 31 days to 365 days of the index procedure.
Key Secondary Endpoints:
Incidence of cranial nerve injury within 30 days of the index procedure
Other Key Secondary Endpoints:
Stroke within 30 days of the index procedure
Death within 30 days of the index procedure
MI within 30 days of the index procedure
Stroke/Death/MI within 30 days of the index procedure
Ipsilateral stroke at 1 year
Additional secondary endpoints:
Persistent cranial nerve injury at 6 months and 1 year
Rate of cardiac death within 30 days of the index procedure
Rate of neurological death within 30 days of the index procedure
Rate of hierarchical ipsilateral stroke, death, and MI within 30 days of the index procedure
Cardiac death at 1 year of patients who experienced an MI within 30 days of the index procedure
Access site complications (arterial/venous)
Serious Hematoma/bleeding complications (arterial/venous access site)
Rate of stent thrombosis or occlusion within 30 days of the index
Procedure
Rate of dissection within 30 days of the index procedure (during index procedure or a reintervention procedure)
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| Follow-up Visits and Length of Follow-up |
1 year
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
344 intent-to- treat patients were enrolled
319 per protocol patients were enrolled
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| Actual Number of Sites Enrolled |
54
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| Patient Follow-up Rate |
99.7% (318/319) of per protocol patients completed 30-day follow-up visit.
93.7% (299/319) of per protocol completed 1 year follow-up visit.
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| Final Safety Findings |
The primary endpoint was defined as the hierarchical composite of major adverse events (MAEs) defined as any death, stroke, or myocardial infarction within 30 days of the index procedure and ipsilateral stroke within 31 days to 365 days following the index procedure. The composite 1-year MAE rate which comprised of strokes only, was 1.4%. The 1-sided 97.5% upper bound of the MAE rate of 2.78% was significantly less than the priori threshold of 8% (p<0.0001). Therefore, the primary endpoint was met.
Key Secondary Endpoint
Incidence of cranial nerve injury (CNI) within 30 days of the index procedure was a key secondary endpoint. The CEC adjudicated all suspected CNIs that occur within 30 days of index procedure.
The rate for cranial nerve injury (CN)I within 30 days of the index procedure was 0.63% (2/319). The one-sided 97.5% Upper CI of 2.25% was significantly less than the priori threshold of 2.7%, p= 0.0079.
Rate of Stroke/Death/MI within 30 days of index procedure was 0.6% (2/319), 95% CI: 0.1%, 2.2%.
Rate of stroke within 30 days of index procedure was 0.6% (2/319), 95% CI: 0.1%, 2.2%.
Rate of death within 30 days of index procedure was
0.0% (0/319), 95% CI: 0.0%, 1.1%.
Rate of MI within 30 days of index procedure was 0.0% (0/319), 95% CI: 0.0%, 1.1%.
Rate of ipsilateral stroke within 31 days to 365 days of index procedure was 0.7% (2/305), 95% CI:0.1%, 2.3%.
Cranial nerve injury at 6 months was 0.0%, 0/309).
Cranial nerve injury at 1 year was 0.0% (0/304).
Rate of dissection (during index procedure or a
reintervention procedure) was 1.6% (5/319).
Rate of stent thrombosis or occlusion was 0.3% (1/319).
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| Final Effect Findings |
Same as above
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| Study Strengths & Weaknesses |
The study met the primary endpoint of composite MAE defined as any death, stroke, or MI within 30 days of the index procedure and ipsilateral stroke within 31 days to 365 days of the index procedure (1-sided 97.5% upper CI was 2.78% for MAE rate of 1.41% versus priori of 8%, p< 0.0001).
The study also met the key secondary endpoint of incidence of cranial nerve injury within 30 days of the index procedure (1 -sided 97.5% upper CI was 2.25% for CNI rate of 0.63% vs priori of 2.25%, p= 0.0079).
This was an open label, single arm- study.
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| Recommendations for Labeling Changes |
Labeling update is recommended with the final PAS results.
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