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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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AGENT IDE Continued Follow-up Study


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General
Study Status Study Pending
Application Number /
Requirement Number		 P230035 / PAS002
Date Original Protocol Accepted 02/29/2024
Date Current Protocol Accepted  
Study Name AGENT IDE Continued Follow-up Study
Device Name AGENT Paclitaxel-Coated Balloon Catheter
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives To assess the safety and effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.

A prospective, multi-center, 2:1 randomized (AGENT to POBA), controlled, single-blind, superiority trial.
Study Population Subjects meeting the clinical and angiographic inclusion and exclusion criteria for the AGENT IDE trial
Sample Size 600
Key Study Endpoints The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel, or cardiac death. The MI events include the Peri-Procedural MI (PPMI) according to the SCAI MI definition and the spontaneous MI according to the 4th Universal MI definition.
Follow-up Visits and Length of Follow-up 5 years


AGENT IDE Continued Follow-up Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/29/2024    
1 year report 02/28/2025    
2 year report 02/28/2026    
3 year report 02/28/2027    
4 year report 02/28/2028    


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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