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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-NIRTRAKS


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General
Study Status Progress Adequate
Application Number P110004 S001/ PAS001
Date Current Protocol Accepted 11/01/2017
Study Name OSB Lead-NIRTRAKS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objective is to assess the incidence of target vessel failure (TVF) within 3 years after treatment with the NIRxcell Stent System.
Study Population Description Patients with symptomatic ischemic heart disease due to a single de novo stenotic lesion contained within native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length that is amenable to percutaneous revascularization with percutaneous coronary intervention with stent deployment.
Sample Size A total of 65 subjects will be enrolled from up to 15 sites in the US. Assuming loss to follow-up estimated at approximately 7.0% per year, it is anticipated that 52 evaluable subjects will be available for analysis after 3 years.
Data Collection Primary Endpoint

Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 3 years post-procedure.

Secondary endpoints

-TVF at 9 months

-All Death at 30 days, 1, 2 and 3 years

-Cardiac Death at 30 days, 1, 2 and 3 years

-All cause MI at 30 days, 1, 2 and 3 years

-Target vessel MI at 30 days, 1, 2 and 3 years

-Clinically driven TVR at 30 days, 1, 2 and 3 years

-Clinically driven target lesion revascularization (TLR) at 30 days, 1, 2 and 3 years

-Acute Success Rates

Device Success: Attainment of < 50% final residual stenosis of the target lesion using only Presillion plus Stent Systems.

Lesion Success: Attainment of < 50% final residual stenosis of the target lesion using any percutaneous method.

Procedure Success: Attainment of < 50% residual stenosis of the target lesion and no in-hospital death, MI, or TLR.

Stent Thrombosis at hospital discharge, at 30 days, 1, 2 and 3 years.

Follow-up Visits and Length of Follow-up Patients will be followed up for 3 years.

Follow-up will be performed at 30 days, 1, 2 and 3 years post-procedure.


OSB Lead-NIRTRAKS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/19/2014 11/13/2014 Overdue/Received
one year report 12/19/2014 01/23/2015 Overdue/Received
18 month report 06/19/2015 07/21/2015 Overdue/Received
two year report 12/19/2015 01/15/2016 Overdue/Received
three year report 12/18/2016 12/19/2016 Overdue/Received
four year report 12/18/2017 12/18/2017 On Time
five year report 12/18/2018    


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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