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

Trial Summary

What is the purpose of this trial?

To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (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 data supports the effectiveness of the BlueLeaf System treatment for chronic venous insufficiency?

Research on endovenous laser treatment (EVLT), a similar therapy, shows it is effective in treating chronic venous insufficiency by improving vein function and patient satisfaction, with high rates of ulcer healing and low complication rates. ^{1 2 3 4 5}

Is the BlueLeaf System safe for treating chronic venous insufficiency?

The BlueLeaf System, used for forming venous valves without implants, was evaluated for safety in a study and found to be safe in the midterm for treating deep vein reflux, a condition related to chronic venous insufficiency. ^{6 7 8 9 10}

Research Team

Fletcher Wilson

Principal Investigator

Intervene, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

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

Endovenous laser treatment of varicose veins. [2007]

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

Greater energy delivery improves treatment success of endovenous laser treatment of incompetent saphenous veins. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Post-operative Benefit of Compression Therapy after Endovenous Laser Ablation for Uncomplicated Varicose Veins: A Randomised Clinical Trial. [2018]

4. Japan pubmed.ncbi.nlm.nih.gov

[ENDOVENOUS LASER TREATMENT FOR VARICOSE VEINS]. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Role of endovenous laser treatment in the management of chronic venous insufficiency. [2016]

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

Safety and feasibility report on nonimplantable endovenous valve formation for the treatment of deep vein reflux. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Braided nitinol stent for chronic iliofemoral venous disease - the real-world BLUEFLOW registry. [2021]

8. England 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. [2016]

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

Endoscopic variceal ligation: an alternative to sclerotherapy. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness of foam sclerotherapy for the treatment of varicose veins. [2016]