LimFlow Stent Graft System for Critical Limb Ischemia

Recruiting at 29 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

Trial Summary

What is the purpose of this trial?

A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.

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 data supports the effectiveness of the LimFlow Stent Graft System treatment for Critical Limb Ischemia?

Research on similar stent-graft systems, like the E-liac Stent Graft System, shows success in treating artery issues by maintaining blood flow and preventing leaks. This suggests that the LimFlow Stent Graft System might also be effective in improving blood flow in patients with Critical Limb Ischemia. ^{1 2 3 4 5}

How is the LimFlow Stent Graft System treatment different from other treatments for critical limb ischemia?

The LimFlow Stent Graft System is unique because it uses a technique called percutaneous deep vein arterialization (pDVA), which reroutes blood flow from arteries to veins in the foot to improve circulation in patients with no other treatment options, potentially preventing amputation and promoting wound healing. ^{6 7 8 9 10}

Research Team

Daniel Clair, MD

Principal Investigator

Vanderbilt University

Mehdi Shishehbor

Principal Investigator

University Hospital Cleveland

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Occlusive and aneurysmal peripheral arterial disease: assessment of a stent-graft system. [2004]

2. England pubmed.ncbi.nlm.nih.gov

Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Endovascular repair of arterial iliac vessel wall lesions with a self-expandable nitinol stent graft system. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Endoluminal femoropopliteal bypass for intermittent claudication. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Patency and limb salvage after infrainguinal bypass with severely compromised ("blind") outflow. [2019]

6. United States 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. [2019]

7. United States 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. [2022]

8. United States 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. [2022]

9. Switzerland 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Prevention of high flow problems of arteriovenous grafts. Development of a new tapered graft. [2019]