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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Durability II PAS


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General
Application Number P110023 / PAS001
Current Plan Approved 11/23/2016
Study Name OSB Lead-Durability II PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The PAS is a prospective, multi‐center, non‐randomized, single arm study with sequential enrollment of all qualified subjects undergoing treatment of atherosclerotic lesions in the native superficial femoral artery or the superficial femoral and proximal popliteal arteries. All eligible subjects who provide informed consent will undergo PTA and stenting using the EverFlex device. Follow‐up will take place at pre‐ discharge, 30 days, 1 year, 2 years and 3 years.
Study Population Description Adult patients with lesions no greater than 180 mm in length in the native superficial femoral artery or the superficial femoral and proximal popliteal arteries, who do not meet any of the exclusion criteria for this device.
Sample Size The sample size of 113 is driven by the need for the above noted precision confidence interval for stent fracture rate. This sample size will ensure precision of the stent fracture rate at 1 year with a 95% confidence interval of 1.3% to 7.9%, assuming a proportion of 4.6% and

10% attrition at 1 year. Also, assuming that the true 36‐month composite primary endpoint rate is 55% (with a performance goal of greater than 35%) and 30% attrition at 36 months, the resulting 118 evaluable subjects are greater than the 79 required to power the primary endpoint.¿



Twenty (20) to 30 sites will be used in the study.

Data Collection Primary endpoints

A composite endpoint defined as freedom from acute death, freedom from 36‐month amputation, and freedom from 36‐month clinically‐

driven target lesion revascularization



Secondary endpoints

 Freedom from stent fracture at 1, 2, and 3 years

 Freedom from 36‐month amputation at 1, 2, and 3 years

 Freedom from 36‐month clinically driven target lesion revascularization at 1, 2, and 3 yrs

 Freedom from acute death (within 30 days of the procedure)

 Device success ¿ ability to employ the device as intended

 Improvement in Rutherford clinical category at one year

 Improvement in ankle‐brachial index at one year

 Walking improvement at one year

 Adverse events, including all cause mortality

Follow-up Visits and Length of Follow-up Follow‐up visits will occur pre‐discharge, at one month, at one year, and annually thereafter, up to three years.


OSB Lead-Durability II PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/05/2012 08/24/2012 On Time
one year report 03/07/2013 03/05/2013 On Time
18 month report 09/05/2013 09/04/2013 On Time
two year report 03/07/2014 03/04/2014 On Time
three year report 03/07/2015 02/27/2015 On Time
four year report 03/06/2016 03/02/2016 On Time
five year report 03/06/2017    


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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