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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Dual Antiplatelet Therapy


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General
Application Number P070015 / PAS003
Current Plan Approved 07/02/2008
Study Name Dual Antiplatelet Therapy
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this study is to evaluate the effectiveness and safety 12 versus 30 months of dual antiplatelet therapy on the composite of all death, myocardial infarction and stroke free survival, as well as definite or probable ST free survival, in patients treated with drug eluting stents. The patients will be randomized to either their dual anti-platelet therapy or placebo and followed from 12 months to 30 months post index procedure.
Study Population Description The Xience V Everolimus Eluting Coronary Stent System was approved on July 2, 2008. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length < 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm.Study population will consist of event free patients at 12 months
Sample Size Study Phase I (From index procedure to 1 year post stent implantation):8,000 patients, Study Phase II (From 1 year up to 5 years) : All patients enrolled and completed Study Phase I will be evaluated at 1-year to determine their eligibility of participating in one of the three different study cohorts in Study Phase II:1) XIENCE V USA LTF Cohort: The first 1,500 on-label patients and the remaining patients from the initial 5,000 patients who do not participate in the HCRI-DAPT cohort will be included in this cohort. 2) HCRI-DAPT Cohort: Patients who are event free in the first year and are compliant with DAPT will be identified for HCRI. 3) AV-DAPT Cohort: Up to 1,524 patients from the additional 3,000 patients who are event free in the first year and are compliant with DAPT will be included in this cohort. The approximately 440 sequentially enrolled patients from 3,841 to 5,060 that are not included in the HCRI-DAPT study will also be followed to five years post index procedure. Therefore, a total of 4,280 patients (3,840 + 440) will be followed to five years post index procedure by Abbott Vascular. The remaining 780 patients will be followed by HCRI for the HCRI-DAPT study, 275 sites
Data Collection Annual rates of ST cardiac death and myocardial infarction will be determined.
Follow-up Visits and Length of Follow-up Annually to five years. Clinical follow-up will occur at 15, 24, 30 and 33 months.
Final Study Results
Interim Safety Information No results can be shared since this study is being conducted under an IDE.


Dual Antiplatelet Therapy Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 year report 07/02/2011 07/01/2011 On Time
4 year report 07/01/2012 07/02/2012 On Time
5 year report-final report 07/01/2013 02/28/2013 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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