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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Enrollment of New US Cohort


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General
Application Number P110004 / PAS002
Current Plan Approved 04/12/2012
Study Name OSB Lead-Enrollment of New US Cohort
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 information about the safety and effectiveness of the NIRxcell CoCr Coronary Stent RX System in the treatment of de novo stenotic lesions in native coronary arteries in a newly enrolled US population.
Study Population Description A sample size of 131 evaluable patients is needed to demonstrate that the NIRxcell CoCr Coronary Stent RX System TVF rate is less than 33% after three years (80% power and one-sided a=0.05). This sample size accounts for an expected loss to follow-up of approximately 7.5% per year. Patients will be enrolled from up to 15 sites in the USA.
Sample Size see Study population
Data Collection The primary effectiveness endpoint for this study is 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.

The secondary safety endpoints are:

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

Acute Success Rates

Device Success: Attainment of < 50% final residual stenosis of the target lesion using only NIRxcell? 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-Enrollment of New US Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/11/2012 10/22/2012 Overdue/Received
one year report 04/12/2013 11/12/2014 Overdue/Received
18 month report 10/11/2013 11/12/2014 Overdue/Received
two year report 04/12/2014 11/12/2014 Overdue/Received


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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