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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-Beta-Cath Long Term


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General
Study Status Progress Inadequate
Application Number P000018 / PAS001
Date Current Protocol Accepted 02/23/2011
Study Name OSB Lead-Beta-Cath Long Term
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study was initially designed as a prospective study. However, due to the inability to prospectively recruit patients, the study design was modified. The current design is a single site retrospective study of the long term safety and effectiveness of the Beta Cath 3.5F system.
Study Population Description Patients treated with the BethCath 3.5F System. These patients receive beta radiation to the site of successful percutaneous coronary intervention for the treatment of in-stent restenosis in native coronary arteries with discrete lesions in a reference vessel diameter ranging from 2.7 to 4.0 mm.
Sample Size 200 patients, 1 site
Data Collection The primary safety endpoints are: (1) Incidence of device related procedural events and (2) major adverse events at each study point. The primary efficacy endpoints are: 1) device success including successful delivery of source train, return of source train and delivery of intended dose and 2) target vessel revascularization.
Follow-up Visits and Length of Follow-up Patients will be followed clinically at 6 months, 1, 2, 3, 4, and 5 years post treatment. Due to retrospective enrollment, patients may be enrolled at any of the specified time points and followed for subsequent visits.


OSB Lead-Beta-Cath Long Term Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/19/2009 05/19/2009 On Time
1 year report 11/19/2009 11/20/2009 On Time
18 month report 05/19/2010 05/24/2010 Overdue/Received
2 year report 11/19/2010 12/27/2010 Overdue/Received
3 year report 11/19/2011 12/07/2011 Overdue/Received
4 year report 11/19/2012 03/08/2013 Overdue/Received
5 year report 11/19/2013 11/29/2013 Overdue/Received
6 year report 11/19/2014 12/15/2014 Overdue/Received
response to a def (final report) 07/01/2015 07/01/2015 On Time
7 year report 11/19/2015 01/27/2016 Overdue/Received
8 year report 11/19/2016 12/15/2016 Overdue/Received
9 year report 11/19/2017    


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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