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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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OSB Lead-TRYTON Side Branch New Enrollment Study


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General
Study Status Study Pending
Application Number P150039 / PAS003
Date Current Protocol Accepted  
Study Name OSB Lead-TRYTON Side Branch New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description To assure the continued safety and effectiveness of the Tryton Side Branch Stent™ with main branch approved DES in the treatment of de novo native coronary artery bifurcation lesions with side branch diameter ranging from greater than or equal to 2.5 mm to less than or equal to 3.5 mm and main branch diameter ranging from greater than or equal to 2.5 mm to less than or equal to 4.0 mm.



-A prospective, single arm, open label multicenter registry of newly enrolled patients.

Study Population Description U.S. patients with symptomatic, ischemic heart disease due to a stenotic bifurcation lesion located in a de novo native coronary artery, with side branch diameter ranging from greater than or equal to 2.5 mm to less than or equal to 3.5 mm and main branch diameter ranging from greater than or equal to 2.5 mm to less than or equal to 4.0 mm.



Patients must meet all inclusion and exclusion criteria per labeling.



The comparator is performance goal (TVF rate of 18.9% at 1 year) derived from the Tryton IDE Tryton intended cohort, greater than or equal to 2.25 mm subset.

Sample Size A maximum of 335 subjects will be enrolled at minimum of 60 sites and a maximum of 85 sites in the US.



Sample size assumptions are as follows:



Primary endpoint: Incidence rate of TVF (cardiac death, myocardial infarction, target vessel re- vascularization) within 1 year of index procedure.

1-sided test at 0.5 significance level

Power of 85%

Expected TVF rate: 13.4%

Sampling variability adjustment: 5.5%

Reference TVF rate: 18.9% (13.4% + 5.5%)

Expected missing data/attrition: 10%



A continuity-corrected normal approximation (z-test) to the binomial distribution was used in the determination of the sample size.



A sub study of the first 150 patients treated by inexperienced operators will be enrolled and evaluated by the Angiographic Core Laboratory to assess side branch reference vessel diameter.

Data Collection Primary Endpoint



• TVF rate at 1 year post index procedure.



TVF is a composite rate of cardiac death, target vessel myocardial infarction (Q Wave and Non-Q wave MI), and clinically driven TVR.



Secondary Endpoints



1. Device success, defined as attainment of <30% residual stenosis within the side branch without device malfunction



2. Lesion success, defined as attainment of <30% residual stenosis using any percutaneous method



3. Procedure success, defined as lesion success without malfunction or in-hospital MACE, (cardiac death, Q wave or non-Q wave MI, or repeat revascularization of the target lesion during the hospital stay),



and the following secondary endpoints which will be evaluated at 30 days, and annually to 3 years.



4. All-cause and cardiac mortality,



5. Myocardial infarction (MI), Q wave and non-Q wave

6. Clinically driven target lesion revascularization (CD- TLR)



7. Clinically driven target vessel revascularization (CD- TVR)



8. Stent thrombosis, using ARC definition of definite and probable

Follow-up Visits and Length of Follow-up 3 years


OSB Lead-TRYTON Side Branch New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
quarterly report 10/13/2017 10/11/2017 On Time
six month report 01/13/2018   On Time
one year report 07/13/2018    
18 month report 01/13/2019    
two year report 07/13/2019    
three year report 07/13/2020    
four year report 07/13/2021    
five year report 07/13/2022    
Final Report 11/13/2022    


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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