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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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Application Number P060033 / PAS002
Current Plan Approved 09/16/2008
Study Name Registry PROTECT CA
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This post-approval study (PAS) uses the pooled data from the PROTECT and PROTECT Continued Access (CA) studies in on-label patients to evaluate the annual rates of stent thrombosis (ST) and cardiac death (CD) plus myocardial infarction (MI) for all Endeavor on-label patients.

The PROTECT study is a prospective, multi-center, randomized, two-arm, open-label study. The primary objective is to compare the overall stent thrombosis rate of the Endeavor Zotarolimus-Eluting Coronary Stent System versus the Cypher Sirolimus-Eluting Coronary Stent System in a patient population requiring stent implantation.

The PROTECT CA study is a prospective, multi-center, non-randomized, single-arm, open label study. The primary objective is to evaluate the overall stent thrombosis rate of the Endeavor Zotarolimus-Eluting Coronary Stent System in a patient population requiring stent implantation.

Study Population Description The PROTECT and PROTECT CA patient populations include consecutive patients eligible for drug-eluting stent implantation in one or more target lesions. Patients with lesions in native coronary arteries who met all eligibility criteria were enrolled.
Sample Size A minimum of 1,000 Endeavor patients will be enrolled in the US, including:

a. US patients enrolled in the PROTECT study and randomized to ┬┐Endeavor┬┐; and

b. US patients enrolled in a single arm fashion in PROTECT CA.

Sites: 60 to 100 US sites

Data Collection Primary Endpoint

ST rate defined as definite and probable stent thrombosis, according to the ARC definition.

Secondary Endpoint

CD/MI composite endpoint. CD defined as any death due to immediate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia). MI per Medtronic historical definition (Q wave or non-Q wave MI).

Follow-up Visits and Length of Follow-up Length of follow-up: 5 years

Follow up at: 1, 6 , 12, 18, 24, 30, 36, 48, and 60 months

Final Study Results
Interim Safety Information None reported for this portion of study.
Number of Patients The PAS analyses included 1,769 on-label patients.
Number of Sites 64 sites
Follow-up Rate At five years the follow-up rate was 94.6% (1673/1769).
Safety Findings The annual rate of ARC-defined definite and probable stent thrombosis at 5 years for on-label patients in

PROTECT and PROTECT CA studies was 0.06% (1/1673, upper 95% CI: 0.28%, p<0.001).

Effect Findings The 5-year cumulative rate of cardiac death or myocardial infarction for on-label patients in PROTECT and PROTECT CA studies was 6.40% (107/1673). This rate is below the performance goal of 8.4% (p<0.001)
Strengths & Weaknesses The study had a low rate of attrition, thus minimizing selection bias. The study met its performance goals and had a large sample size showing a long-term outcome of the stent
Label Changes A labeling change is not needed because Medtronic Vascular has ceased manufacturing and distribution of the Endeavor Spring OTW and RX devices.

Registry PROTECT CA Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 01/31/2009 01/30/2009 On Time
18 month report 08/01/2009 07/30/2009 On Time
2 year report 01/31/2010 01/28/2010 On Time
3 year report 01/31/2011 01/28/2011 On Time
4 year report 01/31/2012 01/31/2012 On Time
5 year report 01/30/2013 01/30/2013 On Time
6 year report 01/30/2014 01/30/2014 On Time
7 year report-final report 03/31/2015 03/31/2015 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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