Post-Approval Studies (PAS) Database

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

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Cont f/u of PzF SHIELD IDE Cohort

General
Study Status	Completed
Application Number / Requirement Number	P160014 / PAS001
Study Name	Cont f/u of PzF SHIELD IDE Cohort
Device Name	COBRA PzF NanoCoated Coronary Stent System
Clinical Trial Number(s)	NCT01925794 NCT02224235
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: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	Continued follow-up of premarket cohort
Study Population	Single arm study with COBRA device
Sample Size	296 (already enrolled)
Key Study Endpoints	The primary combined safety and effectiveness endpoint is the incidence of target vessel failure (TVF) within 270 days of treatment with the COBRA PzF™ Coronary Stent System. In-stent late lumen loss at 9 months post-implant is a powered secondary endpoint. These endpoints have already been met. Additional secondary endpoints include clinically driven target lesion revascularization and definite or probable stent thrombosis.
Follow-up Visits and Length of Follow-up	5 years Annually
Interim or Final Data Summary
Actual Number of Patients Enrolled	296
Actual Number of Sites Enrolled	35
Patient Follow-up Rate	30, 180, 270, 360, 720, 1080,1 440, 1800 days
Final Safety Findings	At 5 year follow-up, there were a total of 11 deaths adjudicated as cardiac and 23 as non-cardiac, for an all-cause mortality rate of 12.0%. There were a total of 29 Mis by ARC definition within 5 years for an MI rate of 11.3%. The clinically driven TLR rate at 1800 days was 13.5%. There were 9 cases of possible stent thrombosis events through 5 years but no definite or porpable stent thrombosis was reported.
Final Effect Findings	The trial primary endpoint was met: The rate of TVF at 270 days was 11.4% (33/290 patients). The upper limit of the one -sided exact 95% CI was 14.81%, which met the performance goal of 19.62%. The trial powered secondary endpoint was met: The mean in-stent late loss per patient at 270 days was 0.84 (± 0.48)mm with an upper bound of the one-sided 95% CI of 0.93 mm. This was below the performance goal of 1.1 mm.
Study Strengths & Weaknesses	Single arm trial with a limited sample size for confirmatory analysis
Recommendations for Labeling Changes	The sponsor should update their labeling to include the final data from the study.

Cont f/u of PzF SHIELD IDE Cohort Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
one year report	02/21/2018	02/21/2018	On Time
two year report	02/21/2019	02/21/2019	On Time
three year report	02/21/2020	02/18/2020	On Time
final report	02/20/2021	02/24/2021	Overdue/Received

Contact Us

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Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background