LimFlow System for Critical Limb Ischemia

(PROMISE Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the LimFlow System, a new treatment for individuals with chronic limb-threatening ischemia (severe blockage in the leg's blood vessels) who lack other surgical or treatment options. The trial aims to determine if this minimally invasive procedure can improve blood flow and help save the affected limb. It suits those diagnosed with severe limb ischemia who haven't found success with other treatments. Participants should already be part of a wound care program and have a stable primary wound. As an unphased trial, this study offers a unique opportunity to access a potentially life-saving treatment before it becomes widely available.

Do I have to stop taking my current medications for the trial?

The trial does not clearly state if you need to stop taking your current medications. However, if you are on anti-coagulants, the investigator will decide if they interfere with your participation. It's best to discuss your specific medications with the trial team.

What prior data suggests that the LimFlow System is safe for endovascular procedures?

Research shows that the LimFlow System is designed for individuals with serious leg or foot problems, especially when other surgeries or treatments have failed. Studies have found that most patients tolerate this system well. The FDA has evaluated the safety and effectiveness of the LimFlow System, including its potential risks and benefits.

Previous reports have demonstrated that the LimFlow System is safe for those with severe leg conditions. Any unwanted side effects have been closely monitored, and while some have occurred, they are usually manageable. The FDA has already approved the system for treating chronic limb-threatening ischemia, confirming its safety. Prospective trial participants should discuss the potential risks and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The LimFlow System is unique because it offers a new approach for treating critical limb ischemia (CLI), a severe blockage in the arteries of the lower extremities. Unlike traditional treatments like bypass surgery or balloon angioplasty, which focus on clearing or bypassing blockages, the LimFlow System uses a minimally invasive technique to create a new pathway for blood flow, effectively turning a vein into an artery. Researchers are excited about this system because it can potentially save limbs from amputation in patients who have no other surgical options, offering a new lifeline for those with advanced CLI.

What evidence suggests that the LimFlow System is effective for critical limb ischemia?

Research has shown that the LimFlow System works well for patients with severe blood flow problems in their legs who have no other treatment options. In this trial, participants will receive treatment with the LimFlow System. Studies indicate that many patients using this system heal their wounds and avoid losing their limbs. After one year, results showed high rates of limb preservation and improved wound healing. The procedure, called percutaneous deep vein arterialization (pDVA), has proven to provide lasting benefits. Overall, the LimFlow System offers hope for those with few options, demonstrating both safety and effectiveness in treating this serious condition. ^{6 7 8 9 10}

Who Is on the Research Team?

Daniel Clair, MD

Principal Investigator

Vanderbilt University

Mehdi Shishehbor

Principal Investigator

University Hospital Cleveland

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. limflow.com limflow.com/publication-of-one-year-outcomes-from-promise-i-us-study/

PROMISE I U.S. Study Positive One-year Outcomes The LimFlow pDVA system was effective in treating no-option CLTI resulting in a high percentage of treated patients healing their wounds and surviving free of ...

2. limflow.com limflow.com/late-breaking-data-from-promise-i-study-on-limflow-system-confirm-excellent-sustained-outcomes-in-patients-with-no-option-chronic-limb-threatening-ischemia/

Excellent Sustained Outcomes for Patients with CLTI LimFlow confirms excellent sustained outcomes for both amputation-free survival and wound healing from CLTI.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1936879825013524

1-Year Outcomes of Transcatheter Arterialization of Deep ... At 1 year, outcomes following TADV with the LimFlow System demonstrated durable AFS and limb salvage rates, and improvement in wound status, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10886738/

Short-Term Outcomes and Efficacy of Percutaneous Deep ... Percutaneous deep vein arterialization (pDVA) is considered a treatment modality in patients with no-option critical limb ischemia.

5. limflow.com limflow.com/limflow-system-found-to-be-cost-effective/

Percutaneous Deep Vein Arterialization (pDVA) THE LIMFLOW SYSTEM FOUND TO BE COST-EFFECTIVE, ACCORDING TO THE NEWEST STUDY PUBLISHED IN THE JOURNAL OF CRITICAL LIMB ISCHEMIA. Percutaneous ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220025B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options ...

7. limflow.com limflow.com/wp-content/uploads/2020/05/Ischemia-LimFlow.pdf

Critical Limb Ischemia The trial will measure clinical outcomes in terms of time to major adverse event, amputation rates, time to re- intervention, and numbers of ...

8. fda.gov fda.gov/medical-devices/recently-approved-devices/limflowtm-system-p220025

LimFlow™ System - P220025 The LimFlow System is used to treat patients with chronic limb-threatening ischemia ... Summary of Safety and Effectiveness Data (SSED) ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32026120/

PROMISE international; a clinical post marketing trial ... With this prospective study, we evaluate the clinical effectiveness and safety in patients with no-option CLI treated with the pDVA (LimFlow ...

10. limflow.com limflow.com/wp-content/uploads/2023/10/LimFlow-Stent-Graft-IFU.pdf

LimFlow® System The objective of the PROMISE I trial was to evaluate the feasibility, safety, and effectiveness of the LimFlow System in creating a below-the-knee arteriovenous ...