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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-BIOFLEX-I PAS


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General
Study Status Study Pending
Application Number P160025 / PAS001
Date Current Protocol Accepted 08/07/2017
Study Name ODE Lead-BIOFLEX-I PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, non-randomized, multi-center follow-up of the BIOFLEX-I pivotal study (G100002)
Study Population Description The study population included subjects greater than or equal to 18 years old with life-style limiting claudication or rest pain, with an ABI less than or equal to 0.9 (resting or exercise). Inclusion criteria included one de novo, restenotic or occluded femoropopliteal lesion, OR two de novo , restenotic or occluded lesions representing one femoropopliteal indication and one iliac indication on contralateral limbs (i.e., one lesion per limb). Lesion length was specified as less than or equal to 190 mm (if de novo or restenotic) or less than or equal to 100mm (if occluded), with target vessel reference diameter: 2.5 to 6 mm (SFA/PPA) by visual estimate and with angiographic evidence of atleast one distal vessel runoff to the foot.



Sample Size A total of 280 subjects were active at the time of the 12-month primary endpoint assessment. The long-term post-market analysis of the Pulsar stent group will include a minimum of 202 subjects (238 subjects x 0.85) at 36 months and a minimum of 238 subjects (280 subjects x 0.85) at 24 months. This calculation accounts for a 15% annual attrition rate due to premature exits including subject withdrawal and lost to follow (LTF) and excluding deaths.
Data Collection The primary endpoint to be assessed is freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months, as defined by the protocol. The secondary endpoints to be assessed include the following:

Freedom from a composite of clinically-driven TLR and index limb amputation at 24 months.

Major adverse events (MAE) rate (30-day mortality, clinically-driven TLR, and index limb amputation) and their components at 24 months.

MAE rate (30-day mortality, clinically driven TLR, and index limb amputation) and their components at 36 months.

Target lesion revascularization (TLR) rate at 24 months.

Target lesion revascularization (TLR) rate at 36 months.

Stent fracture rate at 24 months.

Stent fracture rate at 36 months.

Adverse events rates at 36 months.

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


ODE Lead-BIOFLEX-I PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 03/23/2018    
two year report 03/23/2019    
three year report 03/22/2020    
four year report 03/22/2021    
five year report 03/22/2022    


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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