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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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) 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

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Study Status Completed
Application Number P160014 / PAS001
Study Name Cont f/u of PzF SHIELD IDE Cohort
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: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of premarket cohort
Study Population Description Single arm study with COBRA device
Sample Size 296 (already enrolled)
Data Collection 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

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 Schedule

Report Schedule
Date Due
FDA Receipt
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

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

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