f Post-Approval Studies (PAS) Database
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

PROMISE III Post-Approval Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Study Pending
Application Number /
Requirement Number
P220025 / PAS002
Date Original Protocol Accepted 10/12/2023
Date Current Protocol Accepted  
Study Name PROMISE III Post-Approval Study
Device Name LimFlow System
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 A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective, single-arm, multi-center study.
To provide additional information on the LimFlow System for creating an AV connection in the below the knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
Study Population Subjects who are confirmed as “no option” (ineligible for conventional endovascular or surgical limb salvage procedures) by the treating physician. “No option” is defined as either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.
Sample Size The study will enroll up to 100 subjects.
Assumptions for sample size estimation: A sample size of 100 subjects with an estimated proportion of 54% success would provide a sufficiently precise estimate with a two-sided 95% confidence interval half-width of 0.0977 or +/- 10%.
Up to 25 sites will be enrolled in the United Sates. Individual site enrollment is capped at 20% of total enrollment. It is estimated that the overall general loss to follow-up will be 10% at the time of primary analysis, and a true loss to follow up rate <10% will incur censoring while a loss > 10% will require sensitivity analyses.
Key Study Endpoints Primary Endpoints Amputation Free Survival (AFS) defined as freedom from major amputation (defined as above-ankle amputation of the index limb) and death (all-cause mortality) at 6 months. Secondary Endpoints: Secondary endpoints to be evaluated at 30days, then 6 months through 36 months • Primary patency • Primary Assisted Patency • Secondary Patency • Limb Salvage • Change in Rutherford Classification • Technical Success • Procedure Success • Target wound Healing • All Wound Area Reduction • Freedom from Contrast Induced Nephropathy • Procedure Time • Radiation Exposure • Contrast Volume
Follow-up Visits and Length of Follow-up Hospital discharge, 14 days, 30 days, 3 and 6 months, at 1 year 2 years and 3 years. Subjects will be followed for 3 years


PROMISE III Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/11/2024    
1 year report 09/10/2024    
18 month report 03/11/2025    
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

-
-