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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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ODE Lead-TRYTON Side Branch Stent PIVOTAL RCT


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General
Study Status Progress Adequate
Application Number P150039 / PAS001
Date Current Protocol Accepted  
Study Name ODE Lead-TRYTON Side Branch Stent PIVOTAL RCT
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description TRYTON Pivotal Randomized Controlled Trial (RCT) - a prospective, multicenter, single blind controlled study. Subjects were randomized 1:1 to the TRYTON Side Branch Stent with main branch approved DES or side branch balloon angioplasty (POBA) and main branch approved DES for treatment of native coronary artery bifurcation disease.



Study Population Description N = 769

704 Randomized (355 TRYTON, 349 POBA)

65 Roll-In (TRYTON)

Sample Size 664 subjects randomized 1:1 to DES+TRYTON vs. DES+POBA

318 subjects randomized 1:1 to DES+TRYTON vs. DES+POBA
Data Collection Primary endpoint: Target vessel failure [TVF, a composite of cardiac death, target vessel MI, and target vessel revascularization (TVR) involving the main branch or side branch] at 9 months



Powered secondary angiographic endpoint: Angiographic in-segment percent diameter stenosis (%DS) in the side branch at 9 months



Other secondary endpoints included a range of safety and effectiveness parameters including acute success, the individual components of TVF (cardiac death, target vessel MI, and TVR), all-cause mortality, rate of stent thrombosis and MACE (and the individual elements of MACE) evaluated at 30 days, 6 and 9 months and annually up to 3 years.



Follow-up Visits and Length of Follow-up 3 years post-index procedure





ODE Lead-TRYTON Side Branch Stent PIVOTAL RCT Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final Report 08/22/2017 06/01/2017 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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