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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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PERSEUS Workhorse and Small Vessel (SV)


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General
Application Number P100023 / PAS001
Current Plan Approved 04/22/2011
Study Name PERSEUS Workhorse and Small Vessel (SV)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Final Study Results
Number of Patients PERSEUS Workhorse: 1,249

PERSEUS Small Vessel: 223

Number of Sites PERSEUS Workhorse: 90

PERSEUS Small Vessel: 28

Follow-up Rate PERSEUS Workhorse: 92% at five years

PERSEUS Small Vessel: 93.7% at five years

Safety Findings PERSEUS Workhorse: Results at five years:

-MACE (cardiac death, MI, TVR)

TAXUS Express (18.2%) and TAXUS Element (18.6%)

-All death

TAXUS Express (6.9%) and TAXUS Element (6.8%)

-All death and MI

TAXUS Express (9.6%) and TAXUS Element (10.6%)

-Non-cardiac death

TAXUS Express (2.9%) and TAXUS Element (3.3%)

-ARC stent thrombosis, definite/probable

TAXUS Express (0.7%) and TAXUS Element (1.1%)



At five years, there were no statistically significant differences between the groups in any of the safety outcomes examined.



PERSEUS Small Vessel: Results at five years:

-MACE (cardiac death, MI, TVR)

TAXUS Element (30.2%) and BMS (41.3%, P<0.05)

-All death

TAXUS Element (14.9%) and BMS (9.6%)

-All death and MI

TAXUS Element (15.9%) and BMS (15.2%)

-Non-cardiac death

TAXUS Element (15.9%) and BMS (15.2%)

-ARC stent thrombosis, definite/probable

TAXUS Element (0.6%) and BMS (2.1%)

Effect Findings PERSEUS Workhorse: Results at five years:

-Target lesion failure (TLF)

TAXUS Express (13.7%) and TAXUS Element (12.8%)

-Target vessel failure (TVF)

TAXUS Express (17.9%) and TAXUS Element (17.5%)

-Target vessel revascularization (TVR)

TAXUS Express (13.3%) and TAXUS Element (13.3%)



There was no statistically significant difference between the groups in any of the effectiveness outcomes examined.



PERSEUS Small Vessel: Results at five years:

-Target lesion failure (TLF)

TAXUS Element (21.5%) and BMS (35.2%, P<0.05)

-Target vessel failure (TVF)

TAXUS Element (30.2%) and BMS (39.4%)

-Target vessel revascularization (TVR)

TAXUS Element (23.6%) and BMS (34.9%, P<0.05)

Strengths & Weaknesses The PERSEUS Workhorse study was prospective, randomized, controlled, single-blind, non-inferiority trial with a sample size of 1,262 subjects. The PERSEUS Workhorse study met its performance goals. The PERSEUS Workhorse PAS included only subjects with a study stent implanted (n=1,249) and followed them up to five years. Strengths of this PAS include randomized treatment assignment; a low rate of attrition in both treatment groups, thus minimizing selection bias; and a large sample size.

The PERSEUS Small Vessel study was a prospective, single-aim, superiority trial with an historical control. A total of 223 subjects were implanted with the TAXUS Element stent and compared with 125 matched bare metal (BMS) Express stent subjects from the TAXUS V trial. The subjects were followed-up to five years. Strengths of this PAS include a control group; and a low 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 cohorts.


PERSEUS Workhorse and Small Vessel (SV) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 year report 04/21/2013 05/18/2011 On Time
3 year report 04/21/2014 05/16/2012 On Time
4 year report 04/21/2015 04/29/2013 On Time
Final Report 04/20/2016 04/08/2014 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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