BlueLeaf System for Chronic Venous Insufficiency

(INFINITE-OUS Trial)

Recruiting at 4 trial locations

Overseen By Tracy Roberts

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Intervene, Inc.

Disqualifiers: Stroke, DVT, Renal insufficiency, 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: Unknown

Duration: 1-2 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the BlueLeaf System for safety and effectiveness in people with chronic venous insufficiency (CVI), a condition where leg veins struggle to send blood back to the heart. The BlueLeaf System creates a new structure inside the vein to improve its function. Candidates may qualify if they have CVI with symptoms such as leg swelling or skin changes and have not improved after six months of compression therapy. The trial aims to assist those with slow blood return in deep leg veins. As an unphased trial, it offers a unique opportunity to contribute to the development of innovative treatments for CVI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the BlueLeaf System is safe for treating chronic venous insufficiency?

Research shows that the BlueLeaf System is undergoing tests for safety and effectiveness in treating chronic venous insufficiency (CVI). Earlier studies have been promising. Reports on safety and feasibility indicate that the BlueLeaf System, which improves valve function in veins, is generally well-tolerated by patients with CVI. These studies reported no major side effects, indicating that serious issues were uncommon.

Although the BlueLeaf System is still under study and not yet approved for CVI, current data suggests it may be safe. Always consult a healthcare provider with any concerns or questions about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BlueLeaf System is unique because it creates an autogenous leaflet to mimic valve function in treating chronic venous insufficiency. Unlike standard treatments like compression therapy or surgical interventions that primarily manage symptoms or repair damaged veins, this system aims to address the root cause by restoring valve function itself. Researchers are excited about this approach because it could potentially offer a more durable solution, reducing the need for ongoing treatments and improving long-term outcomes for patients.

What evidence suggests that the BlueLeaf System is effective for chronic venous insufficiency?

Research has shown that the BlueLeaf System, which participants in this trial will receive, may help treat chronic venous insufficiency (CVI) by correcting deep vein reflux. This condition occurs when vein valves malfunction, leading to poor blood flow. The BlueLeaf System creates a new valve-like structure in the vein to restore normal blood flow. Early results suggest this method could effectively alleviate CVI symptoms. Designed as a non-surgical option, the system might be more accessible for many patients. ^{1 3 4 6 7}

Who Is on the Research Team?

Fletcher Wilson

Principal Investigator

Intervene, Inc.

Are You a Good Fit for This Trial?

This trial is for people with chronic venous insufficiency (CVI) who have symptoms and haven't improved after at least 6 months of compression therapy. They should have a specific type of vein reflux and not be pregnant, recently had a stroke or deep vein thrombosis, or suffer from severe kidney disease, blood disorders, or significant artery disease in the legs.

Inclusion Criteria

I have at least one area in my blood vessel that can be treated.

I have tried compression therapy for over 6 months without improvement.

You have a condition where blood flows the wrong way in your veins for more than 1 second.

Exclusion Criteria

I have untreated vein problems that might be causing my symptoms.

I have not had any vein procedures in the limb of interest in the last 6 months.

I have not had a stroke in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with the BlueLeaf System to form autogenous tissue leaflets in the femoral and popliteal veins

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• BlueLeaf System

Trial Overview

The BlueLeaf System is being tested to see if it can effectively treat CVI by restoring proper function to veins in the leg. The study will look at how safe it is and how well it works for patients who meet certain health criteria.

How Is the Trial Designed?

Group I: BlueLeaf System Experimental Treatment 1 Intervention

The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

BlueLeaf System is already approved in United States for the following indications:

Approved in United States as BlueLeaf System for:

• Symptomatic chronic venous insufficiency (CVI)

Who Is Running the Clinical Trial?

Intervene, Inc.

Lead Sponsor

Trials

4

Recruited

30+

Published Research Related to This Trial

In a study involving 14 patients with chronic venous insufficiency, the BlueLeaf System successfully formed at least one deep venous valve in 93% of cases, demonstrating its efficacy as a minimally invasive treatment option.

There were no serious adverse events or deep venous thromboses reported during the study, indicating a high safety profile for the BlueLeaf System over a 1-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility report on nonimplantable endovenous valve formation for the treatment of deep vein reflux. Vasudevan, T., Robinson, DA., Hill, AA., et al.[2022]

Endovenous laser treatment (EVLT) is an effective method for treating incompetent saphenous veins, with a success rate of 77.5% observed in a study of 111 treated veins followed for an average of 29.5 weeks.

The study found that delivering higher energy doses (over 80 J/cm) significantly increases the likelihood of treatment success, as no failures occurred in veins treated with this energy level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Greater energy delivery improves treatment success of endovenous laser treatment of incompetent saphenous veins. Timperman, PE., Sichlau, M., Ryu, RK.[2016]

Endovenous foam sclerotherapy (EFS) demonstrated high efficacy in treating varicose veins, achieving complete or near-complete obliteration in 99% of treated legs after one injection, with additional injections further improving outcomes.

EFS was found to be a safe outpatient procedure, with common side effects like pain and hyperpigmentation, while serious complications such as thrombosis and skin necrosis were rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of foam sclerotherapy for the treatment of varicose veins. Nael, R., Rathbun, S.[2016]

Endovenous laser treatment (EVLT) is a safe and effective method for treating varicose veins, having been performed on 5,160 legs without severe complications, except for one case of arteriovenous fistula.

EVLT offers a less-invasive alternative to traditional treatments like vein stripping and phlebectomy, making it a favorable option for patients with saphenous insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[ENDOVENOUS LASER TREATMENT FOR VARICOSE VEINS]. Tezuka, M., Kanaoka, Y., Ohki, T.[2015]

In a study of 308 lower limbs treated with the 1470 nm diode laser for varicose veins, the endovenous laser ablation showed a remarkable 99.6% success rate in eliminating venous reflux after one year.

The treatment was found to be safe, with no cases of deep vein thrombosis or pulmonary embolism, and only a low recurrence rate of varicose veins at 2.81%, indicating both high efficacy and safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovenous laser ablation of varicose veins with the 1470 nm diode laser using a radial fiber - 1-year follow-up. von Hodenberg, E., Zerweck, C., Knittel, M., et al.[2016]

Endoscopic variceal ligation (EVL) effectively controls active bleeding from esophageal varices, with 88% of patients experiencing bleeding control during their initial hospitalization.

EVL is a safe procedure with minimal nonbleeding complications, making it a viable alternative to sclerotherapy for treating varices, as evidenced by the study of 68 patients over 16 months with a median of five treatments leading to eradication or reduction of varices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic variceal ligation: an alternative to sclerotherapy. Stiegmann, GV., Goff, JS., Sun, JH., et al.[2019]

In a study of 67 patients with iliofemoral chronic venous disease, the novel blueflow Venous Stent showed a high primary patency rate of 91.7% at 6 months and 79.8% at 12 months, indicating its effectiveness in treating venous outflow obstruction.

Patients experienced significant clinical improvements, with a median reduction in the revised venous clinical severity score (rVCSS) from 8 to 4 over 12 months, and no major safety concerns were reported, suggesting the stent is a safe option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Braided nitinol stent for chronic iliofemoral venous disease - the real-world BLUEFLOW registry. Lichtenberg, M., Stahlhoff, S., Özkapi, A., et al.[2021]

Endovenous laser treatment (EVLT) is an effective and durable therapy for superficial venous insufficiency, providing a rapid, office-based solution with minimal downtime for patients.

EVLT has low complication rates and enhances patient satisfaction, making it a more efficient option compared to traditional surgical treatments for saphenous truncal insufficiency and accessory branches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovenous laser treatment of varicose veins. Gibson, KD., Ferris, BL., Pepper, D.[2007]

In a study of 400 patients with uncomplicated varicose veins undergoing endovenous laser ablation (EVLA), those who wore elastic compression stockings (ECS) post-operatively reported significantly less pain and edema in the first week after surgery compared to those who did not wear ECS.

However, by two weeks post-surgery, pain and edema levels were similar between the two groups, and there were no significant differences in quality of life or time to return to work, indicating that while ECS may provide short-term relief, it does not impact long-term recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-operative Benefit of Compression Therapy after Endovenous Laser Ablation for Uncomplicated Varicose Veins: A Randomised Clinical Trial. Ye, K., Wang, R., Qin, J., et al.[2018]

Endovenous laser therapy (EVLT) effectively treated chronic venous insufficiency in 20 patients, achieving a 100% healing rate for ulcers at 12 months and a 95% rate at 22 months, with only one recurrence noted.

The procedure was safe, with 84% of patients reporting satisfaction and no major complications, while demonstrating consistent long saphenous vein occlusion rates over the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of endovenous laser treatment in the management of chronic venous insufficiency. Sharif, MA., Lau, LL., Lee, B., et al.[2016]

Citations

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thevascularexperts.com/wp-content/uploads/2020/08/CLN004_MKT01.A_Site_24_BlueLeafInfoSheet_Final_updated.pdf

The INFINITE-US Clinical Study

Chronic venous insufficiency (CVI) with incompetence of the deep venous ... The BlueLeaf® Endovenous Valve Formation. System is the first non-surgical ...

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evtoday.com/news/intervenes-blueleaf-endovenous-valve-formation-system-granted-fda-breakthrough-device-designation

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According to Intervene, the BlueLeaf system is designed to correct deep vein reflux—one of the underlying causes of chronic venous insufficiency ...

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sciencedirect.com/science/article/pii/S2213333X20307289

Safety and feasibility report on nonimplantable ...

Chronic venous insufficiency (CVI) is a common disease, affecting more than 30% of adults globally. In the United States, more than 40 million patients suffer ...

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symplr.com/publication/blueleaf-endovenous-valve-formation-evf-system-for-chronic-venous-insufficiency

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... disease (that is, the drug's effectiveness). For example ... Chronic Venous Insufficiency (CVI)Deep Vein Reflux. Chronic Venous ...

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Methods: Feasibility of endovenous deep venous valve formation was assessed in patients with chronic venous insufficiency (Clinical, Etiologic, Anatomic, ...

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Safety and feasibility report on nonimplantable ...

Keywords: Chronic venous insufficiency; Ulcer; Deep vein reflux; Deep veins; Endovenous ... venous valve in the treatment of chronic venous disease. Biomed J.