What side effects are associated with this type of intervention?

Common treatments for Deep Vein Thrombosis (DVT) include anticoagulants such as warfarin, direct oral anticoagulants (DOACs) like dabigatran, rivaroxaban, apixaban, and low-molecular-weight heparin (LMWH). These treatments can cause bleeding complications, from minor bruising to major hemorrhages. Dexamethasone, used locally via the Bullfrog® Micro-Infusion Device, may cause local irritation, infection at the injection site, and systemic effects like hyperglycemia and immunosuppression if significantly absorbed. The device aims to reduce systemic side effects by delivering the drug locally.

What prior FDA approvals exist?

FDA-approved treatments for Deep Vein Thrombosis (DVT) primarily include anticoagulants such as direct oral anticoagulants (DOACs) like dabigatran, rivaroxaban, apixaban, and edoxaban, which help prevent clot formation and reduce the risk of post-thrombotic syndrome. Additionally, low-molecular-weight heparins (LMWH) like enoxaparin are used for their consistent anticoagulation effects. While these treatments focus on anticoagulation, the use of local anti-inflammatory agents like Dexamethasone Sodium Phosphate via the Bullfrog® Micro-Infusion Device is being studied to see if reducing inflammation around the deep veins post-recanalization can prevent re-thrombosis and improve long-term outcomes.

What other types of research exist?

Promising novel alternatives for DVT treatment include: 1) Hemoperfusion with polymyxin-B immobilized fiber, which has shown improvement in oxygenation and survival rates in AE-IPF patients, suggesting potential benefits in reducing inflammation and preventing re-thrombosis. 2) Intravenous recombinant thrombomodulin (rhTM), although not effective in AE-IPF, its anti-inflammatory and anticoagulant properties may still hold potential in DVT treatment pending further research. 3) The use of denosumab, particularly in patients with renal insufficiency, as it avoids nephrotoxicity and may offer benefits in managing bone health and inflammation. These alternatives should be discussed with a healthcare provider to determine the best course of action.

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Perivascular Dexamethasone for Deep Vein Thrombosis (DEXTERITY-AFP Trial)

Phase 2

Waitlist Available

Research Sponsored by Mercator MedSystems, Inc.

Eligibility Criteria Checklist

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

Must have

Onset of acute DVT symptoms of 14 days or less prior to initial intervention in the study limb

DVT located in any of the major femoropopliteal veins, with possible extension downstream into the iliac veins

Must not have

Hemorrhagic stroke within the last 365 days

Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial uses a special tool to deliver an anti-inflammatory medicine directly to deep veins in patients who recently had a vein-clearing procedure for DVT. The goal is to reduce inflammation, prevent re-blockage, and improve symptoms over time.

Who is the study for?

Adults aged 18-89 with recent deep vein thrombosis (DVT) in the leg, who can take oral medication and agree to long-term anticoagulant therapy. They must not be enrolled in other drug/device trials, have a BMI over 45, severe health conditions that affect study participation or outcomes, known allergies to drugs used in the trial, or be pregnant/breastfeeding.

What is being tested?

The trial is testing if injecting dexamethasone directly around veins after DVT removal reduces re-thrombosis and improves symptoms for up to two years. Participants will receive either this treatment or a sham procedure using the Bullfrog® Micro-Infusion Device.

What are the potential side effects?

Potential side effects include reactions at the injection site such as pain or infection, increased blood sugar levels due to dexamethasone (a steroid), and possible systemic effects like mood changes or stomach upset.

Eligibility Criteria

Inclusion Criteria

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

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I started having symptoms of a blood clot in my limb less than 14 days ago.

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I have a blood clot in my thigh vein that may extend to my hip veins.

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My blocked vein was successfully reopened and the clot removed.

Exclusion Criteria

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

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I have not had a bleeding stroke in the past year.

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I have not had eye surgery or a bleeding eye condition in the last 3 months.

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I understand what the clinical trial involves and its importance.

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I have a significant blood clot in my main vein extending above my hip area.

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I have severe leg circulation issues, confirmed by low pressure readings.

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My vein cannot be fully opened due to a clot.

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I was not able to walk before my deep vein thrombosis occurred.

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My blood clot is longer than 50 cm and needs medication.

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My high blood pressure is under control and below 140 mmHg.

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I cannot undergo certain vein treatments due to severe breathing problems or a sudden illness.

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I have not had a brain or spinal cord bleed in the last year.

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I have had leg swelling or pain for more than 14 days, or a blood clot in my leg in the past year.

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My kidney function is severely impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of clinically relevant primary patency

Rate of freedom from major adverse event (MAE)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Group II: ControlPlacebo Group1 Intervention

0 / 16Eligibility 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

Common treatments for Deep Vein Thrombosis (DVT) include anticoagulants, thrombolytics, and anti-inflammatory therapies. Anticoagulants, such as heparin and direct oral anticoagulants (DOACs), work by inhibiting clotting factors to prevent new clots from forming and existing clots from growing. Thrombolytics, like tissue plasminogen activator (tPA), dissolve existing clots by breaking down fibrin, the main protein in blood clots. Anti-inflammatory treatments, such as dexamethasone sodium phosphate delivered via the Bullfrog® Micro-Infusion Device, aim to reduce local inflammation around the veins, which can help prevent re-thrombosis and alleviate symptoms. These mechanisms are crucial for DVT patients as they address both the immediate risk of clot propagation and the long-term complications, such as post-thrombotic syndrome, by improving blood flow and reducing vein damage.

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