What side effects are associated with this type of intervention?

Common treatments for Deep Vein Thrombosis (DVT) include anticoagulants (such as warfarin, heparin, and direct oral anticoagulants like rivaroxaban and apixaban), thrombolytics, and mechanical interventions like compression stockings and surgical procedures. Anticoagulants can cause side effects such as bleeding complications, including gastrointestinal bleeding and intracranial hemorrhage. Thrombolytics, used to dissolve clots, also carry a significant risk of bleeding. Mechanical interventions, including the use of compression stockings, may cause skin irritation or discomfort. For treatments similar to the VenoValve, which involves bioprosthetic valve implantation, potential side effects could include infection, thrombosis at the site of implantation, and valve dysfunction or failure. These interventions aim to restore valve function in the deep venous system and improve venous blood flow.

What prior FDA approvals exist?

The FDA has approved several treatments for Deep Vein Thrombosis (DVT), primarily focusing on anticoagulant medications such as warfarin, low-molecular-weight heparins (e.g., enoxaparin), and newer oral anticoagulants like rivaroxaban and apixaban. These medications help prevent clot formation and reduce the risk of complications. While the VenoValve trial is investigating a bioprosthetic valve implantation to restore valve function in the deep venous system, similar surgical interventions like venous stenting and surgical vein bypass have been explored for severe cases of venous insufficiency. However, specific FDA approvals for bioprosthetic valve implantation in the deep venous system are not detailed in the provided context.

What other types of research exist?

Promising alternatives to the VenoValve for DVT patients include the TandemHeart systems and the implantable Thoratec IVAD, which provide mechanical circulatory support. Additionally, the wear-free implantable DexAide and the minimally invasive Impella RD are emerging technologies that may offer effective treatment options. These devices are designed to improve venous circulation and reduce the risk of thrombotic events.

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Bioprosthetic Venous Valve

VenoValve® Implant for Venous Insufficiency

Q: What is the mechanism of action of this treatment?

The most common treatments for Deep Vein Thrombosis (DVT) include anticoagulants, thrombolytics, and mechanical interventions. Anticoagulants, such as warfarin and direct oral anticoagulants (DOACs) like rivaroxaban, work by inhibiting clotting factors to prevent new clots from forming and existing clots from growing. Thrombolytics, such as tissue plasminogen activator (tPA), dissolve existing clots by breaking down fibrin, the main component of blood clots. Mechanical interventions, including stenting and bioprosthetic valve implantation like the VenoValve, aim to restore proper blood flow and valve function in the deep venous system. These treatments are crucial for DVT patients as they help prevent complications such as post-thrombotic syndrome, reduce the risk of pulmonary embolism, and improve overall venous circulation.

N/A

Recruiting

Research Sponsored by Hancock Jaffe Laboratiores, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Diameter of native target vein ≥8 mm

Must not have

Arterial insufficiency with measured ABI <0.70

Venous stent in the ipsilateral femoral or popliteal vein

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 12 months and annually thereafter through 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects are not listed here, surgical implantation of devices like VenoValve® may cause pain at the surgery site, infection risk from surgery or device itself could lead to inflammation or fever; there might also be risks related to improper function of the implanted valve.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My vein for the procedure is at least 8 mm wide.

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I am not breastfeeding and do not plan to during the study.

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I can attend all follow-up appointments after treatment.

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I have a vein problem due to a clot or other causes.

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I can walk on my own without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood flow through arteries in my legs is significantly reduced.

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I have a stent in the vein of my thigh or knee area.

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I have an active cancer other than non-melanoma skin cancer.

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I have superficial vein reflux.

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I have a blood clotting disorder that can't be managed with blood thinners.

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I had surgery before on the deep veins on one side of my body.

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I cannot take blood thinners due to health reasons.

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My swelling is not caused by vein problems.

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I have a vein inflammation near the skin's surface.

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I have a blockage in my iliac vein or inferior vena cava that is more than half blocked and hasn't been treated.

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My heart condition severely limits my physical activity.

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I have been diagnosed with fibromyalgia.

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I have severe blockage in the veins of my lower limbs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12 months and annually thereafter through 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 12 months and annually thereafter through 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12 months and annually thereafter through 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The primary safety endpoint is the composite of the following Major Adverse Events

Secondary study objectives

Major Adverse Event rates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: VenoValveExperimental Treatment1 Intervention

Subjects who receive VenoValve implant

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Deep Vein Thrombosis (DVT) include anticoagulants, thrombolytics, and mechanical interventions. Anticoagulants, such as warfarin and direct oral anticoagulants (DOACs) like rivaroxaban, work by inhibiting clotting factors to prevent new clots from forming and existing clots from growing. Thrombolytics, such as tissue plasminogen activator (tPA), dissolve existing clots by breaking down fibrin, the main component of blood clots. Mechanical interventions, including stenting and bioprosthetic valve implantation like the VenoValve, aim to restore proper blood flow and valve function in the deep venous system. These treatments are crucial for DVT patients as they help prevent complications such as post-thrombotic syndrome, reduce the risk of pulmonary embolism, and improve overall venous circulation.