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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AGENT Post-Approval Surveillance Analysis

General
Study Status	Study Pending
Application Number / Requirement Number	P230035 / PAS001
Date Original Protocol Accepted	04/11/2024
Date Current Protocol Accepted	06/28/2024
Study Name	AGENT Post-Approval Surveillance Analysis
Device Name	AGENT Paclitaxel-Coated Balloon Catheter
Clinical Trial Number(s)	NCT04647253
General Study Protocol Parameters
Study Design	Active Surveillance
Data Source	External Registry
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	The AGENT Post-Approval Surveillance Analysis is designed to assess acute and long-term safety and effectiveness outcomes associated with the use of the AGENTTM Paclitaxel Coated Balloon Catheter (AGENT DCB) in a routine clinical setting. This is an observational, prospective, non-randomized, multicenter registry surveillance analysis plan that will use data captured in the CathPCI Registry for AGENT DCB patients.
Study Population	All patients enrolled in the CathPCI Registry who undergo a PCI procedure and are treated with AGENT DCB during the 2-year enrollment period.
Sample Size	Number of subjects: 10,000 Assumptions for sample size estimation: n/a Number of sites/sites location: Data will be captured from all sites in the United States that participate in the CathPCI Registry and use AGENT DCB.
Key Study Endpoints	Safety Endpoints: All cause death, MI Effectiveness Endpoints: Revascularization
Follow-up Visits and Length of Follow-up	The CathPCI Registry collects data at baseline, procedure, and discharge. Event data occurring from years 1 and 2 post-procedure will come from the Centers for Medicare and Medicaid Services (CMS) claims data linkage

AGENT Post-Approval Surveillance Analysis Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
9 month report	11/15/2024
1 year report	02/28/2025
18 month report	08/29/2025
2 year report	02/28/2026

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