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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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DIRECT IV Study


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General
Study Status Terminated
Application Number /
Requirement Number		 P210014 / PAS002
Date Original Protocol Accepted 04/08/2022
Date Current Protocol Accepted 04/06/2023
Study Name DIRECT IV Study
Device Name SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Svelte Slender IDS and Direct RX Post-Approval Study
Study Population A prospective, multicenter, non-randomized post-approval study with Direct Rx and IDS Stent Systems
Sample Size Approximately 500 subjects
Key Study Endpoints The primary safety and effectiveness endpoints is percentage of subjects with Target Lesion Failure (TLF) at 12 months post-procedure, defined as cardiac death, non-fatal Target Vessel Myocardial Infarction (TVMI, including Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
Follow-up Visits and Length of Follow-up 36 months


DIRECT IV Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 06/13/2022 06/09/2022 On Time
1 year report 12/13/2022 12/09/2022 On Time


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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