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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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OSB Lead-Continued F/u of Premarket Cohort


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General
Application Number P110010 / PAS002
Current Plan Approved 05/11/2012
Study Name OSB Lead-Continued F/u of Premarket Cohort
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Workhorse (WH) Trial is a prospective, randomized, controlled, single blind, multicenter, non-inferiority trial

Small Vessel (SV) is a prospective, single-arm, multi-center sub-study

Human Pharmacokinetics (PK) is a prospective, single-arm, multi-center, international, observational sub-study

Study Population Description Continued follow-up of the premarket cohorts:

WH - Subjects with a maximum of 2 de novo lesions ≤ 24 mm in length in native coronary arteries ≥2.50 mm to ≤4.25 mm. PROMUS Element (test) vs. PROMUS (control)

SV - Subjects with a single target lesion ≤28 mm in length in a native coronary artery ≥2.25 mm to <2.50 mm. PROMUS Element (test) vs. TAXUS Express (historical control)

PK - Subjects with a maximum of 2 de novo lesions ≤24 mm in length in native coronary arteries ≥2.50 mm to ≤4.25 mm

Sample Size WH 1,532

SV 94

PK 20-30

Approximately 85 sites in the US, 50 in Europe, 15 in the IC region, and 10 in Japan

Data Collection WH target lesion failure (TLF), MI, or death at 12 months

SV - TLF at 12 months

PK - whole blood everolimus levels as delivered by the PROMUS Element stent.

Follow-up Visits and Length of Follow-up Through 5 years post-procedure

12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after the index procedure

Final Study Results
Number of Patients -WH Randomized Clinical Trial: 1530

-SV Subtrial: 94

-PK Subtrial: 22

Number of Sites Actual number of study sites enrolled

-Workhorse (WH) Randomized Clinical Trial: 132

-Small Vessel (SV) Subtrial: 23

-Pharmacokinetics (PK) Subtrial: 5

Follow-up Rate -WH Randomized Clinical Trial: 94%

-SV Subtrial: 93.3%

-PK Subtrial: 100%

Safety Findings -WH Randomized Clinical Trial: At the 5 year follow-up both the PROMUS Element and PROMUS/Xience V stent had good safety rates with no significant difference between the groups in long term clinical outcomes. The PROMUS Element continued to trend toward numerically lower event rates for cardiac death (2.6% and 3.5% respectively). The cardiac death or myocardial infarction (MI) rate at five years for the PROMUS Element and the PROMUS Xience V were 6.2% and 5.7%, respectively. Academic Research Consortium (ARC)-defined (definite/probable) stent thrombosis (ST) at five years was similar among both groups (0.8% and 0.7% respectively).

-SV Subtrial: The cardiac death or MI rate at five years for the PROMUS Element small vessel was 7.0%. No ST events were observed in the study.

-PK Subtrial: There was no death, MI or ST observed during the length of the study.

Effect Findings -WH Randomized Clinical Trial: the 12-month target lesion failure (TLF) primary endpoint was met, indicating non-inferiority of the PROMUS Element stent (3.4% [25/731]) versus the PROMUS/XIENCE V stent 2.9% [21/714], p=0.0013). At the 5 year follow-up, both the PROMUS Element and PROMUS/Xience V stent had low rates of revascularization with no significant difference between the groups in long term clinical outcomes.

-SV Subtrial: The 12-month TLF primary endpoint was met. The TLF rate at 12 months was 2.4% (2/84) with an upper 1-sided 95% confidence interval of 7.31% which is less than the pre-specified performance goal of 21.1% (p<0.0001).

-PK Subtrial: There were no target vessel revascularizations reported.

Strengths & Weaknesses -WH Randomized Clinical Trial: This was a large (>1,500 subjects) randomized clinical trial with a low rate of attrition; therefore, confounding and selection bias were minimized. This study met its primary endpoint and provides longer-term (5-year) performance data for the PROMUS Element Everolimus-Eluting Coronary Stent System.

-Both SV and PK subtrials provide longer-term (5-year) performance for the device although they have small sample sizes.

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 (5-year) performance of the device.


OSB Lead-Continued F/u of Premarket Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/22/2012 05/21/2012 On Time
one year report 11/21/2012 11/14/2012 On Time
18 month report 06/01/2013 05/23/2013 On Time
two year report 11/21/2013 11/21/2013 On Time
three year report 11/21/2014 11/21/2014 On Time
final report 09/18/2015 11/16/2015 Overdue/Received


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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