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 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.
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%.
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.
-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.