LimFlow Stent Graft System for Critical Limb Ischemia

Recruiting at 30 trial locations

Overseen By Kevin Herman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LimFlow, Inc.

Must not be taking: Anticoagulants, Immunosuppressants, others

Disqualifiers: Hepatic insufficiency, Heart failure, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Intraprocedural

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the LimFlow Stent Graft System, a new treatment for individuals with critical limb ischemia, a severe condition where blood flow to the legs is very limited. The researchers aim to determine if this system can improve blood flow when other treatments are not possible. It suits individuals with chronic limb-threatening ischemia who have been advised that regular surgeries or procedures to improve blood flow are not viable. Participants must have a stable primary wound and no recent severe heart issues or infections. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but if you are on anti-coagulants, the investigator will decide if they interfere with your participation. If they do, you may need to adjust or stop them.

What prior data suggests that the LimFlow Stent Graft System is safe for critical limb ischemia?

Research has shown that the LimFlow Stent Graft System treats critical limb ischemia, a severe condition with poor blood flow to the legs. This system provides a new option for patients with no other available treatments.

Previous studies demonstrated the LimFlow System's effectiveness in treating this condition, particularly in saving the leg from amputation. Safety data from these studies indicate that the treatment is generally well-tolerated. However, like any medical procedure, risks exist. Participants in earlier trials experienced some side effects, typical for this type of procedure.

The LimFlow System has been tested in several studies, and the results support its use in specific cases. Understanding the potential side effects and discussing them with a healthcare provider can help participants make informed decisions about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The LimFlow Stent Graft System is unique because it offers a new approach for treating critical limb ischemia, a serious condition often requiring invasive procedures like bypass surgery or amputation. Unlike traditional treatments that primarily aim to restore blood flow through existing pathways, the LimFlow system creates a new channel for blood flow using a stent graft, which can potentially save limbs and enhance recovery. Researchers are excited about this treatment because it could provide a less invasive option with quicker recovery times, offering hope to patients with limited options.

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

Research has shown that the LimFlow Stent Graft System, which participants in this trial will receive, effectively treats critical limb ischemia, particularly for patients with no other treatment options. Studies have found that the LimFlow system can help heal wounds and prevent amputations in many patients. The treatment creates a new route for blood flow in the leg, improving circulation. Early results suggest that the system is safe and can greatly enhance limb health, making it a promising option for severe cases of limb ischemia. ^{1 3 5 6 7}

Who Is on the Research Team?

Mehdi Shishehbor

Principal Investigator

University Hospital Cleveland

Daniel Clair, MD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-95 with severe chronic limb-threatening ischemia, classified as Rutherford 5 or 6, where traditional treatments are not feasible. Candidates must have stable wounds and blood sugar levels (HbA1C <10%), be non-pregnant if of childbearing potential, and able to consent. Exclusions include recent heart attack or stroke, certain kidney diseases, inability to follow the study protocol, severe heart failure, other medical conditions that could interfere with participation, life expectancy under a year, allergies to specific medications or materials used in the procedure.

Inclusion Criteria

I have severe leg circulation problems with ulcers or gangrene.

Your blood sugar levels are well controlled, with a HbA1C level of less than 10%.

The blood vessel near the cross-over point needs to be the right size for the LimFlow stent graft.

Exclusion Criteria

I am on blood thinners that may affect my safety in the study.

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 receive treatment with the LimFlow Stent Graft System to create an arteriovenous connection in the Below The Knee (BTK) vascular system

Intraprocedural

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including wound healing and limb salvage

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LimFlow Stent Graft System

Trial Overview The LimFlow Stent Graft System is being tested in this single-arm study across multiple centers. The device aims to create new pathways for blood flow in patients whose limbs are at risk due to poor circulation from peripheral arterial disease.

How Is the Trial Designed?

Group I: Treated with LimFlow Experimental Treatment 1 Intervention

Treatment with the LimFlow Stent Graft System

LimFlow Stent Graft System is already approved in United States for the following indications:

Approved in United States as LimFlow System for:

• Chronic limb-threatening ischemia (CLTI) with no suitable endovascular or surgical revascularization options

Who Is Running the Clinical Trial?

LimFlow, Inc.

Lead Sponsor

Trials

4

Recruited

430+

Published Research Related to This Trial

In a study of 32 patients with no-option chronic limb-threatening ischemia (CLTI) treated with the LimFlow device for percutaneous deep venous arterialization (pDVA), the procedure achieved a high technical success rate of 96.9% and demonstrated significant amputation-free survival rates of 83.9% at 6 months and 67.2% at 24 months.

The treatment also showed promising outcomes for wound healing, with 79.8% of patients achieving complete wound healing by 24 months, indicating that pDVA could be an effective option to prevent amputation and promote healing in high-risk CLTI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm Outcomes of Percutaneous Deep Venous Arterialization With a Dedicated System for Patients With No-Option Chronic Limb-Threatening Ischemia: The ALPS Multicenter Study. Schmidt, A., Schreve, MA., Huizing, E., et al.[2022]

Endovascular repair of iliac arterial lesions using a self-expandable Nitinol stent graft system showed a primary technical success rate of 81.3% and a clinical success rate of 75% among 16 patients over a median follow-up of 22.4 months.

The procedure demonstrated a low complication rate, with only 6.3% experiencing minor complications and another 6.3% facing major complications, indicating that this method is both safe and effective for treating various types of iliac arterial lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular repair of arterial iliac vessel wall lesions with a self-expandable nitinol stent graft system. Mensel, B., Kühn, JP., Hoene, A., et al.[2021]

The LimFlow stent-graft system demonstrated 100% amputation-free survival at both 30 days and 6 months in a study of 10 patients with critical limb ischemia who were ineligible for other treatments, indicating its potential safety and effectiveness.

Technical success was also 100%, with significant wound healing observed: by 6 months, 30% of patients achieved complete wound healing, suggesting that this novel percutaneous deep vein arterialization approach could be a viable option for patients facing amputation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interim Results of the PROMISE I Trial to Investigate the LimFlow System of Percutaneous Deep Vein Arterialization for the Treatment of Critical Limb Ischemia. Mustapha, JA., Saab, FA., Clair, D., et al.[2019]

The LimFlow pDVA System demonstrated a high technical success rate, with 97% of the 32 patients treated successfully, and showed promising amputation-free survival rates of 91% at 30 days, 74% at 6 months, and 70% at 12 months.

Wound healing was also notable, with 67% of patients showing healing at 6 months and 75% at 12 months, indicating the potential efficacy of this treatment for patients with no-option chronic limb-threatening ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PROMISE I: Early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia: 12-month results. Clair, DG., Mustapha, JA., Shishehbor, MH., et al.[2022]

Routine tapering of the arterial end of PTFE arteriovenous dialysis grafts to a diameter of less than 5 mm has significantly reduced issues related to high output cardiac failure and peripheral steal, improving blood flow measurements of 2 to 3 liters/min.

Prototype tapered PTFE grafts have shown good performance and acceptance over a 12-month period, indicating their efficacy and potential as a reliable option for dialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of high flow problems of arteriovenous grafts. Development of a new tapered graft. Rosental, JJ., Bell, DD., Gaspar, MR., et al.[2019]

The stent-graft system demonstrated high initial technical success in treating occlusive lesions and aneurysms in 105 patients, with a primary patency rate of 97% at the iliac level, indicating effective treatment for peripheral vascular disease.

While the stent-graft showed good outcomes at the iliac level, the femoropopliteal level had lower primary patency (59%) and a higher rate of complications, suggesting that while the device is feasible, its effectiveness varies by location.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occlusive and aneurysmal peripheral arterial disease: assessment of a stent-graft system. Henry, M., Amor, M., Cragg, A., et al.[2004]

In a study of 274 patients undergoing infrainguinal bypass procedures, grafts with blind outflow (no patent outflow vessels) achieved similar long-term graft patency rates (67%) compared to those with at least one patent outflow vessel (64%).

However, the limb salvage rate was significantly lower for patients with blind outflow (67%) compared to those with patent outflow (76%), indicating that while grafts can remain open, the risk of limb loss is higher in cases of severely compromised outflow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patency and limb salvage after infrainguinal bypass with severely compromised ("blind") outflow. Desai, TR., Meyerson, SL., Skelly, CL., et al.[2019]

In a study of 45 patients, the E-liac Stent Graft System demonstrated a high clinical success rate of 90% and a 100% survival rate at 12 months, indicating its safety and effectiveness for treating aorto-iliac conditions.

The primary patency rates for the internal and external iliac arteries were both very high at 98%, with a low re-intervention rate of only 5%, suggesting that the device maintains its effectiveness over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results. Brunkwall, JS., Vaquero-Puerta, C., Heckenkamp, J., et al.[2020]

In a pilot study involving 14 patients with severe leg pain due to artery blockage, endoluminal femoropopliteal bypass showed initial feasibility, but had low primary patency rates of 35.7% at 1 year and 14.3% at 2 years, indicating challenges in maintaining graft function.

Despite the low patency rates, the technique may still be a viable alternative to traditional surgery for patients with intermittent claudication, especially as experience and technical improvements are gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoluminal femoropopliteal bypass for intermittent claudication. Tisi, PV., Cowan, AR., Morris, GE.[2016]

The first UK case of percutaneous deep vein arterialisation (pDVA) using the LimFlow System in a 'no-option' chronic limb-threatening ischaemia (CLTI) patient showed immediate resolution of ischaemic rest pain and successful revascularisation of the foot.

At 18 months post-procedure, the patient experienced significant wound healing and limb salvage, demonstrating the efficacy of the pDVA procedure, although minor amputations were still necessary, highlighting the need for ongoing clinical monitoring and potential re-interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early and eighteen month clinical outcomes of first UK case of percutaneous deep vein arterialisation (pDVA) to treat "no option" chronic limb-threatening ischemia using the LimFlow system. Lechareas, S., Sritharan, K., Williams, RGM.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30819976/

Interim Results of the PROMISE I Trial to Investigate ... pDVA using the LimFlow system is a novel approach for treating patients with no-option CLI and may reduce amputation in this population.

2. 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 ...

3. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03124875

PROMISE I Early Feasibility Trial of the LimFlow Stent Graft ... This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0741521421007370

PROMISE I: Early feasibility study of the LimFlow System ... The LimFlow percutaneous deep vein arterialization system was effective in treating no-option critical limb-threatening ischemia.

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

LimFlow® System Indications for Use: The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8353042/

Early and eighteen month clinical outcomes of first UK case ... This case report demonstrates the clinical outcomes of a technically-successful standardised pDVA procedure with the LimFlow system including both limb salvage ...