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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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SPIRIT Small Vessel (SV) Registry

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Application Number P070015 S054/ PAS001
Current Plan Approved 05/24/2011
Study Name SPIRIT Small Vessel (SV) Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description Prospective, single-arm, open-label, US multi-center registry study to evaluate the safety and effectiveness of the 2.25 mm XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.

Sample Size 150 subjects enrolled at up to 75 sites in the United States
Data Collection The primary endpoint is the composite rate of cardiac death, target vessel myocardial infarction (MI) (per protocol definition), and clinically indicated target lesion revascularization (CI-TLR) at 1 year. This endpoint meets a pre-specified performance goal of 20.4% derived from the 2.25 mm DES data that was obtained in a literature review.
Follow-up Visits and Length of Follow-up Clinical F/U: 30 days (clinic visit), 240 days and 1 year (clinic visit), 2, 3 years (clinic or telephone visit).

Angiographic F/U: 240 days (only subjects in the angiographic cohort who received a 2.25 mm XIENCE V EECS are eligible).

Final Study Results
Number of Patients 150
Number of Sites 33
Follow-up Rate 88.2%
Safety Findings The overall (0 - 1123 days) definite/probable stent thrombosis rate per ARC was 1.5% (2/130).
Effect Findings -MACE Rates at 3 years: 12.1% (16/132)

-TVR rates at 3 years: 13.6% (18/132)

-TLF rates at 3 years: 12.1% (16/132)

-Cardiac Death rates at 3 years: 3.8% (5/132)

Strengths & Weaknesses Results provide further evidence of the clinical utility and safety of this device. The study had an acceptable rate of attrition, thus minimizing selection bias.
Label Changes A labeling change is recommended to add a summary of the post-approval study results including study strengths and limitations. The updated label will reflect the long-term performance of the device from the pre-market cohort.

SPIRIT Small Vessel (SV) Registry Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 11/22/2011 12/21/2011 Overdue/Received
two year report 05/23/2013 02/12/2013 On Time
three year report-final report 05/23/2014 06/28/2013 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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