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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Continued F/u of Premarket and OUS Cohort


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General
Study Status Completed
Application Number P110013 S005/ PAS002
Date Current Protocol Accepted 02/22/2013
Study Name Continued F/u 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 The 38 mm Length Group is designed as a prospective analysis of the pooled data from patients treated with a 38 mm stent from two multi-center, non-randomized studies, RESOLUTE US (R-US) and RESOLUTE Asia (R-Asia).
Study Population Description Subjects enrolled in the Global Resolute Clinical Program
Sample Size 223 subjects (Consists of patients from 38 mm sub studies of R-US (N=114) and R-Asia (N=109))
Data Collection Primary Endpoints

Stent Thrombosis rates from 12-24, 24-36, 36-48 and 48-60 months

Cardiac Death/TV MI annual rates up to 5 years post procedure.
Follow-up Visits and Length of Follow-up Patient Contact (assessed by telephone, email and/or office visit):

Annually 2, 3 years (R-Asia)*

Annually 2, 3, 4, 5 years (R-US)

Note: R-Asia patients were consented for 5 years. At 3 years if the event rates are demonstrated to plateau or decrease as compared to the rates in the prior years the Steering Committee and Sponsor may consider stopping further follow-ups.
Interim or Final Data Summary
Actual Number of Patients Enrolled 3004 subjects (including 223 subjects with de novo lesions treated with Resolute 38 mm length and 2781 subjects other than 38mm length in the Global Resolute Clinical Trial Program). There were 2240 on-label, which were followed for five years. All of the 223 subjects in the 38 mm Length Group were on-label.

Actual Number of Sites Enrolled The Global Resolute Clinical Trial Program includes the following studies: Resolute FIM, Resolute All-Comers, Resolute International, Resolute US, Resolute Asia, and Resolute Japan.

Patients of the 38 mm Length group were enrolled at 46 sites in the United States (US) and throughout Asia (Bangladesh, India, Hong Kong, Malaysia, Singapore, and Thailand) . Patients were enrolled at 29 sites in the 38mm Length Sub-study of the Resolute-US Clinical Study. Patients of the 38 mm group were enrolled at 17 sites in the Resolute-Asia Clinical Study.

Patient Follow-up Rate Pooled (Global Resolute Clinical Trial Program): 96.70% (2905/3004)at 5 years 38mm: 92.82% (207/223) at 5 years
Final Safety Findings The annual incidence rate for ARC definite/probable ST (48-60 months) for the on label population in the Global RESOLUTE Clinical Trial Program was 0.1% (3/2154) and the upper bound of the one-sided 95 percent confidence interval was 0.4%. The incidence rate for ARC definite/probable ST in Pooled populations at five years was 0.8% (18/2154) for on-label subjects. The 60-month rate of ARC definite/probable ST for the 38 mm length group was 1.4% (3/217). The rate of ARC definite/probable ST for the 38 mm length group was 0.9% (2/221) at 30 days, 12 months, 24 months, and 36 months, and 1.4% (3/220) at 48 months.



The rate of Cardiac Death / Target Vessel Myocardial Infarction at five years of follow-up for the pooled results of the Global RESOLUTE Clinical Trial Program was 7.6% (164/2154) for on-label subjects. It was 8.8% (19/217) for the 38 mm length group. At 5 years the TLF rate of 13.8% is still numerically less than the performance goal of 19% proposed for 1 year. The study met the primary safety endpoint.

Final Effect Findings The acute success rates for on-label subjects at five years of follow-up (R-FIM, R-AC, R-US, R-J, and R- Asia) are as follows: Procedural success 97.7% (2171/2221), Device success: 98.2% (2508/2554) and Lesion success 99.9% (2546/2548). The acute success rates of 38 mm length group at five years of follow-up are as follows: Procedural success 96.3% (210/218), Device success 97.0% (257/265) and Lesion success 100.0% (263/263). The study met the primary effectiveness endpoint.
Study Strengths & Weaknesses The Resolute Integrity Zotarolimus-Eluting Coronary Stent System Extended Length (Resolute Integrity XL) study met the primary endpoint and provided long term data. However, the study experienced difficulty with recruiting eligible subjects.
Recommendations for Labeling Changes Labeling change is recommended to reflect the long term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow –up visits etc.), final results and study strengths and limitations of the PAS.


Continued F/u of Premarket and OUS Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 02/22/2014 03/31/2014 On Time
two year report 03/31/2015 03/30/2015 On Time
three year report 03/31/2016 02/29/2016 On Time
Final Report 03/31/2017 03/28/2017 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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