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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Outcomes TAXUS ATLAS


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General
Study Status Completed
Application Number /
Requirement Number
P060008 / PAS001
Date Original Protocol Accepted 10/10/2008
Date Current Protocol Accepted 10/10/2008
Study Name Outcomes TAXUS ATLAS
Device Name TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Interim or Final Data Summary
Interim Results The MACE (cardiac death, MI, and TVR) rate at 4 years post stent implantation was comparable between the TAXUS ATLAS Group and the Control Group (22.5% versus 23.8%, P=0.5015). There was no statistically significant difference in MI, cardiac death, TVR, TLR, stent thrombosis and death rates between the two groups. The principal safety and efficacy outcomes just noted in the interval from 3 to 4 years post stent implantation were comparable as well. Despite greater lesion complexity in the TAXUS ATLAS Group, the 4 year post implantation data presented by the sponsor demonstrate that the TAXUS Liberté stent is comparable to the TAXUS Express stent with respect to MACE (including individual MACE components cardiac death, MI, and TVR), TLR, and TVF. There are no new safety or effectiveness concerns raised by this data.
Actual Number of Patients Enrolled 867
Actual Number of Sites Enrolled 60
Patient Follow-up Rate 91.7%
Final Safety Findings The MACE (cardiac death, MI, and TVR) rate at 5 years post stent implantation was comparable between the TAXUS ATLAS Group and the Control Group (26.2% versus 27.1%, P=0.7026). There was no statistically significant difference in MI, cardiac death, TVR, TLR, overall stent thrombosis and death rates between the two groups. The 1461-1855 day stent thrombosis rate was 2.4% in the TAXUS ATLAS group and 0% in the control group. This, with a 5-year stent thrombosis rate of 2.3% in the TAXUS ATLAS group and 2% in the control group.
Final Effect Findings See above
Study Strengths & Weaknesses Despite greater lesion complexity in the TAXUS ATLAS Group, the 5 year post implantation data presented by the sponsor demonstrate that the TAXUS Liberté stent is comparable to the TAXUS Express stent with respect to MACE (including individual MACE components cardiac death, MI, and TVR), TLR, and TVF.
Recommendations for Labeling Changes The 1461-1855 day stent thrombosis rate was 2.4% in the TAXUS ATLAS group and 0% in the control group. This, with a 5-year stent thrombosis rate of 2.3% in the TAXUS ATLAS group and 2% in the control group is higher than would be expected and was updated in a labeling change.


Outcomes TAXUS ATLAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 10/10/2009 08/14/2009 On Time
2 year report 10/10/2010 05/05/2010 On Time
Final Report 10/10/2011 10/18/2010 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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