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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-Cont Followup of Premarket and OUS Cohort


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General
Application Number P110013 / PAS002
Current Plan Approved 02/17/2012
Study Name OSB Lead-Cont Followup of Premarket and OUS Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description These analyses will utilize the pooled data from the Global RESOLUTE Clinical Trial Program on-label usage patients (RESOLUTE All Comers (R-AC) and RESOLUTE International (R-Int), RESOLUTE initial feasibility trial (R-FIM), the pre-approval trial for Japan, RESOLUTE Japan (R-J), and the RESOLUTE US (R-US)).



Objectives:

1) Demonstrate the safety in terms of stent thrombosis (ST) when the drug-eluting stent is used in accordance with the labeled indications from 12-24, 24-36, 36-48, and 48-60 months post implant. (36-60 months excludes R-Int)



2) Demonstrate the safety in terms of cardiac death (CD) and target vessel myocardial infarction (TVMI) when the drug-eluting stent is used in accordance with the labeled indications.

Study Population Description The study population consists of four studies (R-FIM, R-AC, R-US, and R-J) with a five-year follow-up and one study with a three year follow-up (R-Int).



The Global RESOLUTE Clinical Trial Program has currently amassed a dataset with a combined total of 5,130 subjects with follow-up at or greater than one year. This dataset consists of 2,349 Subjects considered to be ¿off-label¿ and 2,781 ¿on-label¿ subjects (Table 1).

Sample Size Within the on-label subjects, a sample size of 1,312 will have 80% power to demonstrate the rate of ARC definite probable ST to be significantly less than 1% year-to-year. The Resolute program will have 2,781 on-label subjects scheduled for three years of follow-up and 2,017 on-label subjects scheduled for four and five years of follow up. Therefore, the Pooled Resolute program will have a large enough sample size with or without the RESOLUTE International Registry subjects.
Data Collection Primary Endpoint

ARC definite or probable ST rates from 12-24, 24-36, 36-48 and 48-60 months.



CD/TVMI annual rates up to 5 years post procedure.

Follow-up Visits and Length of Follow-up Data collection will be annually up to 5 years of follow-up, except for R-Int (36 months)
Final Study Results
Number of Patients 2,017 on-label subjects

764 complex subjects

Number of Sites RESOLUTE All Comers (R-AC): 17 sites

RESOLUTE initial feasibility trial (R-FIM): 12 sites

RESOLUTE Japan (R-J): 14 sites

RESOLUTE United States (R-US): 116 sites

Follow-up Rate On-label: 96% (1937/2017) Complex: 98% (751/764)
Safety Findings Objective 1:

The annual rate of Academic Research Consortium (ARC)-defined definite and probable stent thrombosis (ST) at 5 years for on-label patients pooled from four studies (R-FIM, R-AC, R-US, and R-J) part of the Global RESOLUTE Clinical Trial Program was 0.02% (3/1937, upper 95% CI: 0.4%).



The 5-year cumulative rate of ARC- definite/probable ST through five years was 0.8% (15/1937) for on- label subjects and 2.5% (19/751) for complex subjects.



Objective 2:

The 5-year cumulative rate of cardiac death or myocardial infarction for on-label and complex subjects pooled from four studies (R-FIM, R-AC, R-US, and R-J) part of the Global RESOLUTE Clinical Trial Program was 7.5% (145/1937) and 11.9% (89/751), respectively.

Effect Findings Procedural success: 97.9% (1961/2003)

Device success: 98.3% (2251/2289)

Lesion success: 99.9% (2283/2285)

Strengths & Weaknesses This study provides longer term (5 years) safety and effectiveness results of the Resolute Zotarolimus- Eluting Coronary Stent System. This study followed up the premarket cohorts through five years post- procedure. The study had a very low rate of attrition, thus minimizing selection bias. It demonstrated that the Resolute Zotarolimus-Eluting Coronary Stent System had a rate of ARC-definite/probable ST to be significantly less than 1% year-to-year. Although three of the four trials were conducted outside the US, 70% of the on-label subjects (1402/2017) were enrolled in the US. There were no complex subjects enrolled in US sites.
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-years) postmarket performance of the device.


OSB Lead-Cont Followup of Premarket and OUS Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 02/16/2013 03/27/2012 On Time
two year report 02/16/2014 03/29/2013 On Time
three year report 03/31/2014 03/31/2014 On Time
four year report 03/31/2015 03/30/2015 On Time
final report 06/15/2015 06/15/2015 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
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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