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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-Surveillance Post Market Registry


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General
Study Status Progress Adequate
Application Number P140010 S015/ PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-Surveillance Post Market Registry
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description To assess the long-term safety and performance of the IN.PACT Admiral DCB in a U.S. population for the treatment of ISR lesions in the superficial femoral and popliteal arteries.

Prospective, non-randomized, multi-center, single-arm post-market registry
Study Population Description Patients from the U.S. with ISR lesions in the superficial femoral and popliteal arteries who have symptoms of claudication and/or rest pain (Rutherford Class 2, 3, or 4) who were entered into the VQI PVI Registry and met all other inclusion and exclusion criteria.
Sample Size 300 patients from the SVS VQI Registry, treated with the IN.PACT Admiral DCB per the standard of care, will be extracted consecutively and analyzed to evaluate the safety and performance of the IN.PACT Admiral DCB in a U.S. population for the treatment of ISR lesions in the femoropopliteal artery.



According to literature research on the performance of DCB in the treatment of ISR femoropopliteal lesions, the 12-month TLR rate for IN.PACT Admiral DCB treatment is expected to be 16%. Assuming 10% attrition at the 12-month follow-up, with 270 evaluable patients, the precision of the assumed 16% point estimate can be assessed by calculating the difference from the 1-sided 95% upper confidence limit. This difference, or margin of error, is calculated to be 4.1%.

Data Collection Primary:

Target lesion revascularization (TLR) within 12 months post-index procedure.

Secondary:

1. All-cause mortality at 12 months and 24 months.

2. Target lesion revascularization (TLR) at 24 months.

3. Target vessel revascularization (TVR) at 12 months and 24 months.

4. Major target limb amputation at 12 months and 24 months.
Follow-up Visits and Length of Follow-up 36 months


OSB Lead-Surveillance Post Market Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/08/2017 03/03/2017 On Time
one year report 09/07/2017 09/01/2017 On Time
18 month report 03/08/2018    
two year report 09/07/2018    
three year report 09/07/2019    
four year report 09/06/2020    
five year report 09/06/2021    


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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