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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-Extended followup of the EXPERT CTO Study


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General
Study Status Progress Adequate
Application Number P070015 S122/ PAS001
Date Current Protocol Accepted 03/03/2017
Study Name OSB Lead-Extended followup of the EXPERT CTO Study
General Study Protocol Parameters
Study Design Prospective 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 This study is the continued follow-up of the premarket cohort. It is a prospective, multi-center, single-arm study.

Study Population Description All patients in whom recanalization and predilatation of CTO are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.

Sample Size A total of 250 patients were enrolled at 20 sites in the United States, with the intention-to-treat population consisting of 222 patients. There are 205 patients available with 1-year follow-up.

Data Collection The following outcomes will be reported annually through 5 years:

XRate of Major Adverse Cardiac Events (MACE), defined as a composite of death, Myocardial Infarction (MI), or clinically- driven Target Lesion Revascularization (TLR), and individual MACE components



¿XTarget Lesion Failure (TLF), defined as a composite of cardiac death, target vessel-related MI, and clinically-driven TLR and individual TLF components



¿XTarget Vessel Revascularization (TVR) and clinically-driven TVR

¿XTarget Vessel Failure (TVF), defined as a composite of cardiac death, target vessel-related MI, and clinically-driven TVR

¿XOccurrence of stent fracture at target lesion, as assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up at any time during the 5-year study period (the same angiographic core lab will continue to be utilized throughout the five-year follow-up period)

¿XStent thrombosis according to Academic Research Consortium

(ARC) criteria (all, definite, definite/probable, probable, possible): acute, subacute, late, very late and accumulative rates

Follow-up Visits and Length of Follow-up 3 years post-procedure


OSB Lead-Extended followup of the EXPERT CTO Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 10/03/2015 10/07/2015 Overdue/Received
two year report 10/02/2016 09/30/2016 On Time
Final Report 06/30/2017 06/26/2017 On Time


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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