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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ROADSTER 3 PAS


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General
Study Status Ongoing
Application Number /
Requirement Number
P140026 S016/ PAS001
Date Original Protocol Accepted 04/28/2022
Date Current Protocol Accepted 08/19/2022
Study Name ROADSTER 3 PAS
Device Name ENROUTE Transcarotid Stent System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
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).
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)
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.
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)
Follow-up Visits and Length of Follow-up 1 year


ROADSTER 3 PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/19/2023    
1 year report 08/19/2023    
18 month report 02/19/2024    
2 year report 08/19/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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