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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-PAS 2 (New Enroll. of Female Pat. Study)


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General
Study Status Progress Adequate
Application Number P130024 / PAS002
Date Current Protocol Accepted 10/14/2016
Study Name OSB Lead-PAS 2 (New Enroll. of Female Pat. Study)
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description To demonstrate the superior effectiveness and non-inferior safety of the Lutonix Catheter to an Objective Performance Goal (OPG) for treatment of stenosis of the femoropopliteal arteries in the US female population.



This study is a prospective, multicenter, single-arm study.

Study Population Description US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per IFU with the Lutonix Catheter.
Sample Size The study will 160 enroll female subjects. A sample size of 135 completer subjects was determined to provide 90% power for the primary efficacy analysis assuming the true primary patency rate at 12 months in the studied population is at least 0.65 (65%). Based a response rate of 84.5%, the sample size of 135 provides 90% power for a prospective analysis study evaluating the primary safety hypothesis above with a one- sided 0.05 ? level. This sample size was adjusted to 160 to allow for up to 15% drop-out through the 12 month assessment.

Data Collection The primary safety endpoint is the composite of freedom from all-cause peri-operative (?30 day) death and freedom at 1 year

from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.

The primary effectiveness endpoint is primary patency of the target lesion at 12 months. Primary patency is defined as freedom from TLR and from Binary Restenosis. Binary Restenosis is adjudicated by the independent Core Laboratory based on PSVR greater than or equal to 2/5 and/or abnormal waveforms or based on angiographic greater than or equal to diameter stenosis.



Secondary endpoints will be assessed at 1, 6, 12 and 24 months:



Rate of unanticipated and anticipated device-related serious adverse events

All-cause death

TLR

Major Vascular Complications (<30 days)

Follow-up Visits and Length of Follow-up 24 months

Clinical and Duplex Ultrasound at 1, 6, 12, and 24 Months



OSB Lead-PAS 2 (New Enroll. of Female Pat. Study) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/09/2015 04/10/2015 Overdue/Received
one year report 10/09/2015 10/09/2015 On Time
18 month report 04/08/2016 04/08/2016 On Time
two year report 10/08/2016 10/11/2016 Overdue/Received
three year report 10/08/2017 10/11/2017 Overdue/Received
four year report 10/08/2018    
five year report 10/08/2019    
six year report 10/08/2020    
final report 05/31/2021    


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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