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.
This is a non-randomized, multi-center, prospective, single arm clinical
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 less than or equal to 30 mm that is amenable to percutaneous revascularization with percutaneous coronary intervention with stent deployment.
131 patients enrolled from up to 15 sites in the USA.
¿ Three-year TVF rate for
bare metal stents derived from the meta- analysis is 22%. (95% CI 17.7%, 26.4%).
¿ Performance goal for bare metal stents = 33%
¿ Type I error (a) = 0.05 (one-sided)
¿ Statistical power (1 – ß) = 80%
¿ Expected rate for TVF at 3 years for Presillion plus Stent System = 22%
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
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.
Followup Visits and Length of Followup
Patients will be followed-up for 3 years. Follow-up will be performed at
30 days, 1, 2,
and 3 years post-procedure.
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
The rates [95% Confidence Interval] through 5 years were:
Major Adverse Cardiac Events: 41.7% (30/72) [30.2%,
The rate of cardiac death and MI through 5 years was 29.2% (21/72) [19.0%, 41.1%].
Study Strengths and Weaknesses
This study provides longer term (5 years) safety and effectiveness results of Presillion CoCr Coronary
Stent RX System. The study had a low rate of attrition, thus minimizing selection bias. This study follows up the premarket cohort to provide earlier, descriptive information on long-term performance, as such the study had a small sample size and its results are descriptive. The generalizability of the results from this outside the United States population is limited to Israeli patients. This limitation is being addressed through the conduct of the second condition of approval study, ¿Enrollment of New US Cohort¿. The combined data will provide early information on long-term device performance and generalizable, statistically powered findings.
Recommendations for Labeling Changes
A labeling change is recommended to add a summary of the post-approval study results including
study strengths and limitations. The updated label will reflect the long-term (5-years) postmarket performance of the device.
OSB Lead-Continued f/u of BLAST Placebo Cohort