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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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Study Status Progress Adequate
Application Number P110004 S001/ PAS001
Current Plan Approved 02/10/2017
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 study is a prospective multi-center, non-randomized, single arm clinical study designed to collect and analyze additional information about the safety and effectiveness of the NIRxcell Stent System in the treatment of de novo stenotic lesions in native coronary arteries in a newly enrolled US population.
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 131 patients enrolled from up to 15 sites in the USA.

Sample size assumptions

3-year TVF rate for BMS derived from the meta-analysis is 23.2% (95% CI 19.8%, 26.7%)

Performance goal for BMS = 34.8%

Type I error (alpha) = 0.05 (one-sided)

Statistical power (1 ¿beta)=83%

Expected 3-year TVF rate for NIRxcell Stent System = 23.2%.

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
Date Due
FDA Receipt
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    
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

Phone: (301) 796-6134
Fax: (301) 847-8140

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