f Post-Approval Studies (PAS) Database
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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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Study Status Study Pending
Application Number /
Requirement Number
P190020 / PAS001
Date Original Protocol Accepted 04/14/2022
Date Current Protocol Accepted  
Study Name LEADERS FREE II (LFII) Clinical Study
Device Name BioFreedom Drug Coated Coronary Stent System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The primary objectives of the LFII study were to confirm the reproducibility and the generalizability of the primary findings of the prospective, double blind, randomized LEADERS FREE Study in an independent clinical cohort with substantial North American enrollment.
Study Population patients with coronary artery disease at high risk for bleeding for the treatment of de novo lesions in native coronary arteries with a reference diameter ranging between 2.25 mm and 4.0 mm
Sample Size 2449 patients were consented for the LEADERS FREE II study. Among these, 1246 were screen failures, leaving 1203 patients included in the study. The most common reason for screen failure was the failure to meet one or more inclusion criteria, occurring in 92.5% (1153/1246) screen failed patients.
Key Study Endpoints Safety
The composite of cardiac death and myocardial infarction at six months.
The incidence of clinically driven target lesion revascularization at six months.
Follow-up Visits and Length of Follow-up 36 months

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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