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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-Extended Study of Premarket Cohort


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General
Study Status Progress Adequate
Application Number P160003 / PAS001
Study Name ODE Lead-Extended Study of Premarket Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up PAS (PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System BIOHELIX-I Study) was a prospective, non-randomized, multi-center, Investigational Device Exemption (IDE) study designed to demonstrate the safety and effectiveness of BIOTRONIK’s PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System in subjects with atherosclerotic disease of native coronary arteries.



Study Population Description All 329 subjects were in the device group



Sample Size 329 subjects total



Data Collection Primary Endpoint: TVF rate at 9 months post-index procedure.

Secondary Endpoints: Secondary endpoints were not tested with formal hypotheses and only reported with descriptive statistics, including estimated rates and the associated exact, two-sided 95% confidence intervals.

TVF rate (primary endpoint at 9 months)

Individual components of the TVF rate (cardiac death, MI, ischemia-driven TVR)

Overall TVR rate

Target Lesion Failure (TLF) rate, including individual components of the TLF rate (cardiac death, MI, ischemia-driven Target Lesion Revascularization (TLR))

Overall TLR rate

Rate of all-cause mortality and all cause MI, including individual components

Stent thrombosis rate

Index procedure success

Device success

Lesion success

Angina pectoris classification

Rates for individual adverse event

Follow-up Visits and Length of Follow-up 36 months


ODE Lead-Extended Study of Premarket Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 02/14/2018    
two year report 02/14/2019    
three year report 02/14/2020    
four year report 02/13/2021    
five year report 02/13/2022    


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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