LimFlow System for Critical Limb Ischemia

(PROMISE Trial)

Recruiting at 22 trial locations

Overseen By Thomas Engels

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LimFlow, Inc.

Must not be taking: Anticoagulants, Immunosuppressants

Disqualifiers: Hepatic insufficiency, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-procedure

105 Participants Needed

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

You are a childbearing potential woman

I am scheduled for a minor amputation on my foot or toe within 30 days after a procedure.

I have been on dialysis for more than 6 months, use an AV fistula or peritoneal access, and meet the specified health criteria.

Exclusion Criteria

I have an active immune disorder or am on immunosuppressant therapy.

The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study

I have severe heart failure that might make surgery risky.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the LimFlow System procedure to create an AV connection in the Below The Knee (BTK) vascular system

Immediate post-procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments of primary and secondary patency, wound healing, and limb salvage

12 months

Multiple visits (in-person)

Treatment Details

Interventions

• LimFlow System

Trial Overview This trial tests the LimFlow System, which is a minimally invasive procedure designed for patients with severe arterial blockages in their limbs that cannot be treated by traditional surgeries or therapies.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

Treated with the LimFlow System

Who Is Running the Clinical Trial?

LimFlow, Inc.

Lead Sponsor

Trials

4

Recruited

430+