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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-Continued f/u of BLAST Placebo Cohort

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Application Number P110004 / PAS001
Current Plan Approved 04/12/2012
Study Name OSB Lead-Continued f/u of BLAST Placebo Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.

Sample Size 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%

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.

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.
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.

Final Study Results
Number of Patients 74 subjects
Number of Sites 12 sites
Follow-up Rate 93.2% (69/74)
Safety Findings The rates [95% Confidence Interval] through 5 years were:

Major Adverse Cardiac Events: 41.7% (30/72) [30.2%, 53.9%]

Clinically driven target lesion(s) revascularization: 20.8% (15/72) [12.2%, 32.0%] All-cause mortality: 2.8% (2/72) [0.3%, 9.7%]

Myocardial Infarction (MI) (ST-segment elevation MI and non-ST segment elevation MI): 27.8% (20/72) [17.9%, 39.6%]

Stent Thrombosis: 2.8% (2/72) [0.3%, 9.7%] Acute: 0.0% (0/72) [0.0%, 5.0%]

Sub-acute: 1.4% (1/72) [0.0%, 7.5%]

Late: 1.4% (1/72) [0.0%, 7.5%]

Very Late: 0.0% (0/72) [0.0%, 5.0%]

Effect Findings The rate of cardiac death and MI through 5 years was 29.2% (21/72) [19.0%, 41.1%].
Strengths & 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.
Label 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 Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/11/2012 10/22/2012 Overdue/Received
one year report 04/12/2013 04/12/2013 On Time
18 month report 10/11/2013 11/15/2013 Overdue/Received
two year report 04/12/2014 06/06/2014 Overdue/Received
Final Report 05/12/2015 05/08/2015 On Time

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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