VenoValve® Implant for Venous Insufficiency
(SAVVE Trial)
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the VenoValve implant through an open surgical technique
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Hancock-Jaffe bioprosthetic venous valve (VenoValve®)
Hancock-Jaffe bioprosthetic venous valve (VenoValve®) is already approved in United States for the following indications:
- 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
Syntactx
Collaborator
AXIOM Real Time Metrics
Collaborator