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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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PROMISE II Continued Follow-up Study


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General
Study Status Ongoing
Application Number /
Requirement Number
P220025 / PAS001
Date Original Protocol Accepted 09/11/2023
Date Current Protocol Accepted  
Study Name PROMISE II Continued Follow-up Study
Device Name LimFlow System
Clinical Trial Number(s) NCT03970538 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives To evaluate the long-term safety and effectiveness of the LimFlow System. The study is a single-arm, prospective, multi-center follow-up of the pivotal PROMISE II trial (G160156) that treated 105 subjects from 20 investigational sites in the United States.
Study Population All remaining subjects treated with the LimFlow System in the PROMISE II trial active at the end of 6 months evaluation.

The PROMISE II study population comprised of subjects who were confirmed as “no option” (ineligible for conventional endovascular or surgical limb salvage procedures) by the Independent Review Committee.

There is no comparator group for the continued follow-up study.

Sample Size One hundred and two (102) active subjects from the PROMISE II IDE trial.
Key Study Endpoints Endpoints to be assessed at 9, 12, 24 and 36 months include
• Rutherford Classification
• Wound, Ischemia, and foot Infection (WIfI) grade
• Wound assessment
• Amputation and/or reintervention of the stent graft
• Device or procedure related adverse events and serious adverse events
• Review of concomitant medications (antiplatelets/anticoagulants),
• All-cause mortality
• Stent graft patency by duplex examination
Follow-up Visits and Length of Follow-up 3 years


PROMISE II Continued Follow-up Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/10/2024 09/09/2024 On Time
2 year report 09/10/2025    
3 year report 09/10/2026    
4 year report 09/10/2027    


Contact Us

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

Additional Resources

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