LimFlow System for Critical Limb Ischemia
(PROMISE Trial)
Trial Summary
What is the purpose of this trial?
This trial investigates the safety and effectiveness of the LimFlow System, a device that helps improve leg blood flow in patients with severe blood flow issues who can't be treated with usual treatments. It works by creating a new artery-to-vein connection below the knee to enhance circulation.
Research Team
Daniel Clair, MD
Principal Investigator
Vanderbilt University
Mehdi Shishehbor
Principal Investigator
University Hospital Cleveland
Eligibility Criteria
The PROMISE II trial is for adults aged 18-95 with chronic limb-threatening ischemia who have no other surgical or endovascular options available. Candidates should be part of a wound care network, able to follow medication and visit schedules, not pregnant if of childbearing potential, and may include those on dialysis with stable conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the LimFlow System procedure to create an AV connection in the Below The Knee (BTK) vascular system
Follow-up
Participants are monitored for safety and effectiveness, including assessments of primary and secondary patency, wound healing, and limb salvage
Treatment Details
Interventions
- LimFlow System
Find a Clinic Near You
Who Is Running the Clinical Trial?
LimFlow, Inc.
Lead Sponsor