In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
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.
see Study population
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.
Followup Visits and Length of Followup
Patients will be followed-up for 3 years. Follow-up will be performed at 30 days, 1,