LimFlow System for Critical Limb Ischemia
(PROMISE Trial)

Recruiting in Palo Alto (17 mi)

+22 other locations

Overseen byMehdi Shishehbor

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: LimFlow, Inc.

No Placebo Group

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 am between 18 and 95 years old.

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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.

See 12 more

Treatment Details

Interventions

LimFlow System (Device)

Trial OverviewThis 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

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

Treated with the LimFlow System