f Post-Approval Studies (PAS) Database
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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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LIFE-BTK RCT Continued Follow-up Study


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General
Study Status Study Pending
Application Number /
Requirement Number		 P230036 / PAS001
Date Original Protocol Accepted 04/26/2024
Date Current Protocol Accepted  
Study Name LIFE-BTK RCT Continued Follow-up Study
Device Name Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study is a prospective, randomized (2:1, Esprit BTK:PTA), single-blinded, multi-center follow-up of the pivotal LIFE-BTK RCT trial.
Study Population Continued follow-up of the Esprit BTK and PTA (control) arm subjects
Sample Size Total enrolled: 261 subjects. Continued follow-up of all 231 remaining subjects, active at the end of the 1-year evaluation.
Key Study Endpoints Continued follow-up at the timepoints will include the following assessments: medication review, adverse events review, Ankle-Brachial Index (ABI)/Toe-Brachial Index (TBI) measurements, functional status (Rutherford Becker), new wound assessment, and duplex ultrasound (1-year, 2-year and 3-year follow-ups only).
Follow-up Visits and Length of Follow-up 5 years


LIFE-BTK RCT Continued Follow-up Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 04/26/2025    
2 year report 04/26/2026    
3 year report 04/26/2027    
4 year report 04/25/2028    


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

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