75 Participants Needed

VenoValve® Implant for Venous Insufficiency

(SAVVE Trial)

Recruiting at 30 trial locations
MG
NG
KB
Overseen ByKevin Belteau
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial is testing the VenoValve System, an artificial valve that is surgically placed in leg veins. It aims to help patients with severe vein valve problems by improving blood flow. The study will check if this treatment is safe and effective. The VenoValve is a new prosthetic venous valve being tested for the first time in humans to treat chronic venous insufficiency.

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

The trial protocol does not specify if you need to stop taking your current medications. However, you must be able to comply with a post-operative anticoagulation regimen, and certain conditions like chronic narcotic usage or untreated hypercoagulable conditions may affect eligibility.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must be able to comply with a post-operative anticoagulation regimen, so discuss your current medications with the trial team.

What data supports the idea that VenoValve® Implant for Venous Insufficiency is an effective treatment?

The available research shows that the VenoValve® Implant is a promising treatment for chronic venous insufficiency. In a human trial, the VenoValve was tested for its safety and performance, indicating it could be a feasible option for patients with severe forms of the condition. Additionally, the study on patient selection suggests that the VenoValve is most beneficial for those with significant blood flow issues, like chronic venous insufficiency, compared to other conditions. This suggests that the VenoValve may be more effective than other treatments, which often fail or have complications over time.12345

What data supports the effectiveness of the VenoValve treatment for venous insufficiency?

Research shows that the VenoValve treatment has been tested in humans and dogs, demonstrating initial safety and performance in humans and maintaining function in dogs for several months. Additionally, a similar treatment using a prosthetic patch showed improvement in a patient with chronic venous insufficiency, suggesting potential benefits of prosthetic valves.12345

What safety data is available for the VenoValve® treatment?

The provided research does not contain specific safety data for the VenoValve® treatment or its other names like Hancock-Jaffe bioprosthetic venous valve. The articles focus on other medical devices and treatments, such as the ALLEGRA valve, Janus kinase inhibitors, and adalimumab biosimilars. Therefore, no relevant safety data for VenoValve® is available in the given research.678910

Is the VenoValve® treatment a promising option for venous insufficiency?

Yes, the VenoValve® treatment is promising because it offers a new option for patients with severe venous insufficiency, a condition where blood struggles to return from the legs to the heart. Current treatments often fail, but the VenoValve® has shown potential in early studies to improve blood flow and quality of life for patients.1231112

How is the VenoValve treatment different from other treatments for venous insufficiency?

The VenoValve is unique because it is a prosthetic venous valve designed to replace faulty valves in the veins, which is a novel approach for treating chronic venous insufficiency. Unlike other treatments, it specifically targets the mechanical failure of the venous valves, aiming to restore normal blood flow from the legs to the heart.1231112

Research Team

MG

Marc Glickman, MD

Principal Investigator

Hancock Jaffe Laboratories, Inc

Eligibility Criteria

This trial is for adults over 18 with severe leg vein problems (C4b-C6) who haven't improved after 3 months of standard care. They must be able to have an ultrasound, walk unaided, not be pregnant or breastfeeding, agree to birth control if applicable, and have a BMI under 40. People can't join if they've had recent blood clots, other trials within 30 days, certain vein procedures within six weeks, untreated major vein blockages, specific heart conditions or sensitivities to materials in the device.

Inclusion Criteria

I have tried standard treatments like compression therapy for over 3 months without success.
Willing and able to comply with all compulsory study procedures and provide informed consent prior to any study procedures being performed
I am 18 years old or older.
See 12 more

Exclusion Criteria

You regularly use strong pain medications for a long time.
My blood flow through arteries in my legs is significantly reduced.
I have a stent in the vein of my thigh or knee area.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the VenoValve implant through an open surgical technique

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Multiple visits at 30 days, 3, 6, 12 months, and annually thereafter

Treatment Details

Interventions

  • Hancock-Jaffe bioprosthetic venous valve (VenoValve®)
Trial OverviewThe study tests the VenoValve®, a bioprosthetic valve surgically placed into deep veins as a treatment for patients whose leg veins don’t close properly causing swelling and ulcers. It's a single-group study where all participants receive the valve to see how safe and effective it is.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: VenoValveExperimental Treatment1 Intervention
Subjects who receive VenoValve implant

Hancock-Jaffe bioprosthetic venous valve (VenoValve®) is already approved in United States for the following indications:

🇺🇸
Approved in United States as VenoValve for:
  • Under investigation for deep venous valvular insufficiency (C4b-C6 patients); not yet approved

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hancock Jaffe Laboratiores, Inc

Lead Sponsor

Trials
1
Recruited
80+

Syntactx

Collaborator

Trials
23
Recruited
1,147,000+

AXIOM Real Time Metrics

Collaborator

Trials
4
Recruited
750+

Findings from Research

The VenoValve, a prosthetic venous valve, was successfully implanted in 10 patients with severe chronic venous insufficiency (C5-C6), achieving a 100% technical success rate and showing promising early results in improving clinical outcomes and quality of life after 6 months.
Patients demonstrated significant improvements, including a 61% decrease in venous clinical severity scores and a 57% decrease in pain scores, indicating that the VenoValve may be an effective treatment option for those suffering from severe CVI.
Human trial using the novel bioprosthetic VenoValve in patients with chronic venous insufficiency.Ulloa, JH., Glickman, M.[2022]
The study identified that patients with chronic venous insufficiency (CVI) classes 4 to 6, right heart hypertrophy (RHH), and right heart failure (RHF) are the most likely to benefit from a venous valve prosthesis, as simulations showed a significant reduction in mechanical stress ratios for these groups.
Conversely, patients with deep venous thrombosis (DVT) are least likely to benefit from the prosthetic valve due to low flow conditions, although the valve may be useful for post-thrombotic patients after thrombus removal and flow restoration.
Prosthetic venous valve patient selection by validated physics-based computational models.Chen, HY., Berwick, ZC., Kemp, A., et al.[2018]
A new prosthetic vein valve was successfully implanted in 10 dogs without the use of anticoagulants, showing promising results for treating venous insufficiency.
After 3 to 8 months, the prosthetic valves maintained patency and competency, indicating potential for effective long-term use in managing venous insufficiency.
Experimental prosthetic vein valve.Taheri, SA., Rigan, D., Wels, P., et al.[2019]

References

Human trial using the novel bioprosthetic VenoValve in patients with chronic venous insufficiency. [2022]
Prosthetic venous valve patient selection by validated physics-based computational models. [2018]
Experimental prosthetic vein valve. [2019]
Femoral vein valve incompetence: treatment with a xenograft monocusp patch. Preliminary report. [2012]
Role of vessel-to-prosthesis size mismatch in venous valve performance. [2018]
Novel self-expanding ALLEGRA transcatheter aortic valve for native aortic stenosis and degenerated bioprosthesis. [2022]
Janus Kinase Inhibitors: Safety in Patients With Psoriatic Arthritis. [2022]
A randomized, adaptive design, double-blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02, a high-concentration (100 mg/mL) Adalimumab biosimilar, in healthy adult subjects (ALVOPAD FIRST). [2022]
Postmarketing safety of biologics and biological devices. [2018]
Safety profiles of adalimumab, etanercept and infliximab: a pharmacovigilance study using a measure of disproportionality in a database of spontaneously reported adverse events. [2015]
The design, development, and evaluation of a prototypic, prosthetic venous valve. [2018]
[Substitute valve at popliteal vein in treating deep venous valve insufficiency of lower extremities]. [2006]