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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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PARCS continued f/u survey


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General
Study Status Progress Adequate
Application Number /
Requirement Number		 P150028 S001/ PAS001
Date Original Protocol Accepted 10/24/2017
Date Current Protocol Accepted  
Study Name PARCS continued f/u survey
Device Name Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives The objective of this surveillance is to characterize longer-term safety and effectiveness of the CP Covered Stent when used for treatment of right ventricular outflow tract (RVOT) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement (TPVR).
Study Population Subject follow-up will be conducted via distribution of an annual survey to investigators who participated in the PARCS IDE and CAP. The investigational sites will be provided with the CASE ID numbers for all living subjects who were enrolled under the PARCS study or PARCS Continued Access Protocol (CAP) to assist with acquisition of follow up status. The survey distributed to the sites will request information on patients treated with a CP Covered Stent during transcatheter pulmonary valve implantation including: need for catheter or surgical reintervention for a new or enlarging RVOT aneurysm/pseudo-aneurysm, instances of progression of aneurysm or pseudo-aneurysm, instances of structural failure (fracture), or need for device explantation. Survey distribution will continue annually until all patients reach 10 years post-implant. The sponsor will acquire this information from PARCS investigators/hospitals and report results to FDA on an annual basis.
Sample Size Those patients in the PARCS IDE and CAP
Key Study Endpoints The survey distributed to the sites will request information on patients treated with a CP Covered Stent during transcatheter pulmonary valve implantation including: need for catheter or surgical reintervention for a new or enlarging RVOT aneurysm/pseudo-aneurysm, instances of progression of aneurysm or pseudo-aneurysm, instances of structural failure (fracture), or need for device explantation.
Follow-up Visits and Length of Follow-up 10 years


PARCS continued f/u survey Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 10/24/2018 10/23/2018 On Time
two year report 10/24/2019 10/22/2019 On Time
three year report 10/23/2020 10/23/2020 On Time
final report 10/23/2021 10/08/2021 Overdue/Received


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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