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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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PROTECT Study


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General
Application Number P040038 / PAS001
Current Plan Approved 02/05/2007
Study Name PROTECT Study
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 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.
Study Population Description This device is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the criteria outlined as follows:1. Patients with carotid artery stenosis (>50% for symptomatic patients by ultrasound or angiography or >80% for asymptomatic patients by ultrasound or angiography), located between the origin of the common carotid artery and the intra-cranial segment of the internal carotid artery; and 2. Patients must have a reference vessel diameter ranging between 4.8 mm and 9.1 mm at the target lesion. High-risk patients implanted with the Xact stent and Xact stent in the treatment of atherosclerotic carotid artery disease. The stent is used in conjunction with the Emboshield Pro Rapid Exchange Embolic Protection System and the Emboshield BareWire Rapid Exchange Embolic Protection System.
Sample Size 320 patients, 50 sites
Data Collection The primary long-term endpoint is a composite of any death, stroke and myocardial infarction at 30 days plus fatal and non-fatal ipsilateral stroke from 31-365 days and annually thereafter for a total of 3 years. The secondary endpoints for this study include acute device success, procedural success at 30 days, composite of any transient ischemic attack and amaurosis fugax at 30 days, and annual rate of clinically driven target lesion revascularization through 3 years.
Follow-up Visits and Length of Follow-up Annual follow-up through 3 years. No descriptions of enrollment and/or measures for handling follow-up are included in protocol.
Final Study Results
Interim Safety Information There have been no unanticipated adverse device effects or rare events thus far in the trial. The sponsor demonstrates high procedural success rates with very low stroke number and no unanticipated adverse events. (Note: 6.89 % of the pre-market cohort experienced a stroke at 30 days. The data here show no concern about the safety and effectiveness of carotid artery stenting using the Xact stent at 2-years.
Number of Patients A total of 322 patients have been enrolled into the study.
Number of Sites There are a total of 38 study sites that enrolled patients.
Follow-up Rate Follow-up rate is 75.2% (242/322).
Safety Findings

1) A total of six clinically driven target revascularization (TLR) events were reported in five patients. The event free rate is 99.3% at one year, 98.2% at two years, and 98.2% at three years showing a higher (1.0~1.2%) event free percentage compared to the historical control group in the ARCHeR long term follow-up (LTFU) study.

2) Two point five percent (2.5%, 8/322) of patients experienced stoke and zero point nine percent (0.9%, 3/322) of patients experienced MI within 30 days post index procedure. Three point seven percent (3.7%, 12/322) of patients experienced stroke and four point seven percent of patients (4.7%, 15/322) experienced MI between 31 days and 3 years.

Effect Findings

The primary endpoint was a composite of DSMI at 30 days, plus ipsilateral stroke between days 31 and 365 and annually thereafter for 3 years. A total of 14 events were reported of which 11 events occurred within 30 days of procedure and 3 events occurred after 30 days during long-term follow-up. The overall composite event free rate is 96.6% at one year, 95.9% at two years, and 95.5% at three years showing a higher event free percentage at one-, two-, and three-year compared to the historical control group in the ARCHeR long term follow-up (LTFU) study.



Strengths & Weaknesses Strength:

The study provides long term follow-up of patients at high risk for adverse events from carotid endarterectomy implanted with the Xact stent in the treatment of atherosclerotic carotid artery disease.



Weakness:

1) Low percentage of minority group participants restricts the generalization of the results.

2) Only descriptive analysis is available for this study. No statistical tests are being made for the comparison of event free rate between the study cohort and the historical control group in the ARCHeR long term follow-up (LTFU) study.

Label Changes

Yes, labeling will be updated with the 3-year data.



PROTECT Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/06/2006 04/04/2006 Overdue/Received
1 year report 09/06/2006 09/06/2006 On Time
18 month report 03/07/2007 03/08/2007 Overdue/Received
2 Year Report 09/06/2007 08/27/2007 On Time
30 month report 03/07/2008 02/29/2008 On Time
3 Year Report 09/05/2008 06/30/2008 On Time
42 month report 03/07/2009 02/24/2009 On Time
4 Year Report 02/02/2010 02/01/2010 On Time
54 month report 03/07/2010 02/23/2010 On Time
5 Year Report 09/05/2010 09/03/2010 On Time
66 month report 03/06/2011 03/04/2011 On Time
6 year report 09/05/2011 09/06/2011 Overdue/Received
78 month report-FINAL REPORT 03/05/2012 12/12/2011 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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