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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-ROADSTER 2 Registry


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General
Study Status Progress Adequate
Application Number P140026 / PAS001
Date Current Protocol Accepted 04/13/2017
Study Name OSB Lead-ROADSTER 2 Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective:

The purpose of this PAS is to further evaluate the safety and effectiveness of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique



Design:

This is an open-label, single arm, multi-center new enrollment PAS

Study Population Description Patients with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography to be symptomatic (greater than or equal to 50% stenosis) or asymptomatic (greater than or equal to 80% stenosis). Patients will serve as their own comparison group.
Sample Size A minimum of 600 newly enrolled patients from a minimum of 30 sites to a maximum of 100 sites in the US. A maximum of 30 patients per physician will be included in the first 600 patients. The sample size is based on the rate of procedural success within 30 days of the stent implant in comparison to an a priori threshold of 85% derived from the ROADSTER Study. An observed rate of procedural success greater than 89% in the ROADSTER 2

Registry will be significant with a minimum of 600 patients (at 89% success among 600 total cases, the lower binomial confidence limit would be 86.22%).

Data Collection The primary endpoint is the rate of procedural success (defined as technical success in the absence of hierarchical stroke, death, or MI) through 30 days following stent implant.



The secondary endpoints include the following (through 30 days post index procedure):

- Acute device success defined as the ability to insert the device,

establish flow reversal, and remove the device

- Technical success, defined as acute success plus the ability to deliver interventional tools

- Rate of cranial nerve injury

- Rate of hierarchical stroke, death, or myocardial infarction (MI)

- Rate of hierarchical stroke, death or MI by symptom status

- Acute device, technical and procedural success by physician experience

- Acute device, technical and procedural success by physician training level

- Acute device, technical and procedural success by enrollment quartile.

Follow-up Visits and Length of Follow-up Patients will be followed for 30 days (+7 days) post index procedure.


OSB Lead-ROADSTER 2 Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/16/2015 11/16/2015 On Time
one year report 05/17/2016 05/11/2016 On Time
18 month report 11/15/2016 11/14/2016 On Time
two year report 05/17/2017 05/16/2017 On Time
30 month report 11/15/2017   Overdue
three year report 05/17/2018    
42 month report 11/15/2018    
four year report 05/17/2019    
54 month report 11/15/2019    
five year report 05/16/2020    
final report 11/14/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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