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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-IN.PACT SFA Extended f/u study


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General
Study Status Progress Adequate
Application Number P140010 / PAS001
Date Current Protocol Accepted 06/19/2015
Study Name OSB Lead-IN.PACT SFA Extended f/u 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 This is the continued the follow-up of the premarket trial. The

IN.PACT Superficial Femoral Artery (SFA) trial is a two-phase, global, multicenter, single-blind, randomized (2:1 IN.PACT Admiral DCB to Percutaneous Transluminal Angioplasty (PTA)) trial. The SFA I and SFA II trials were conducted in Europe and in the United States, respectively.

Study Population Description 220 subjects treated with the IN.PACT Admiral drug-coated

balloon and 111 subjects treated with percutaneous transluminal angioplasty (PTA) in the SFA I and SFA II trials.

Sample Size Total of 331 subjects: 220 DCB subjects and 111 PTA subjects

It is estimated that from the randomized cohort of the IN.PACT SFA Trial approximately 248 subjects (165 DCB subjects and 83 PTA subjects) will have primary endpoint data at 24 months

Data Collection Primary effectiveness endpoint

Primary patency at 24 months

Primary safety endpoint

Freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically- driven target vessel revascularization (CD-TVR) at 24 months

Secondary study endpoints

Through 60 months

-Major Adverse Event Composite and its individual components (All-cause mortality, CD-TVR, major target limb amputation, and thrombosis at the target lesion site).

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

- All TLR

At 24 and 36 months

-Primary sustained clinical improvement

-Secondary sustained clinical improvement

-Duplex-defined binary restenosis (peak systolic velocity ratio (PSVR) > 2.4) of the target lesion

-Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion

-Quality of Life assessment

-Walking capacity

Follow-up Visits and Length of Follow-up 5 years


OSB Lead-IN.PACT SFA Extended f/u study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 12/30/2015 12/17/2015 On Time
two year report 12/29/2016 12/14/2016 On Time
three year report 12/29/2017    
four year report 12/29/2018    
five year report 12/29/2019    


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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