What is dexamethasone studying for iliofemoral deep vein thrombosis (DVT)?

This trial is studying whether delivering dexamethasone around veins after DVT treatment can reduce inflammation and prevent re-thrombosis. The study focuses on patients who had symptoms for 14 to 60 days before vein recanalization. Mercator MedSystems, Inc. is sponsoring the research to better understand this treatment approach.

Who may be eligible for this iliofemoral deep vein thrombosis clinical trial?

Adults aged 18 to 89 with recent DVT symptoms lasting between 14 and 60 days may be eligible. Both men and women can participate, but women must have a negative pregnancy test and use effective contraception. Participants need to follow anticoagulant medication and be able to attend study visits. Please review eligibility criteria for more details.

Is there any cost to participate in this iliofemoral deep vein thrombosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for their transportation needs.

Actively Recruiting

Phase 2

Age: 18Years - 89Years

All Genders

ID04858776

Perivenous Dexamethasone Therapy Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral Deep Vein Thrombosis

Led by Mercator MedSystems, Inc. · Updated on 2023-10-18

Participants Needed

Research Sites

82 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a medical procedure using the Bullfrog4 Micro-Infusion Device to deliver the anti-inflammatory drug dexamethasone sodium phosphate injection around deep veins after recanalization treatment for iliofemoral deep vein thrombosis DVT. This study focuses on participants who experienced DVT symptoms between 14 and 60 days before the recanalization. The goal is to determine if local anti-inflammatory treatment helps prevent re-thrombosis and improves symptoms for up to 24 months following the procedure. Participants are randomly assigned to receive either the dexamethasone treatment or a saline placebo delivered around the target vein segment with the infusion device. This is a phase 2, quadruple-masked study comparing the effects of perivascular dexamethasone versus a sham procedure following successful DVT recanalization and stenting of the iliofemoral segment. Treatment is given during the recanalization procedure, and participants follow a prescribed anticoagulant and antiplatelet medication regimen. During the study, participants undergo clinical assessments to measure primary vein patency at 6 months and monitor for major adverse events within 30 days after treatment. Follow-up visits and questionnaires continue for up to 24 months to evaluate symptom improvement and vessel health. Researchers will also monitor adherence to medication and overall safety throughout the study duration.

CONDITIONS

Brief Title

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT

Who Can Participate

Age: 18Years - 89Years

All Genders

Eligibility Criteria

You may qualify if you...

Signed informed consent before any study procedures
Willingness to comply with all study procedures and follow-up visits
Male or female aged 18 to 89 years
For women of reproductive potential: negative pregnancy test within 7 days before procedure and use of effective contraception
Negative COVID-19 test within 5 days before procedure or evidence of vaccination/booster in past 12 months
Onset of DVT symptoms 14 to 60 days before intervention with need for iliofemoral stenting
Ability to take oral medication and willingness to follow prescribed anticoagulant regimen
Prescription for at least 14 days of low molecular weight heparin followed by at least 12 months of therapeutic anticoagulant
Minimum of 30 days prescribed antiplatelet therapy (aspirin or P2Y12 inhibitor)
Hemodynamically significant DVT with >50% vein obstruction spanning specified vein segments
Successful recanalization of target vein with at least one patent inflow vein

You will not qualify if you...

Current enrollment in another non-registry systemic drug or device study that has not completed primary endpoint
Inability to understand the clinical trial implications
Body Mass Index over 40 kg/m2
Non-ambulatory before DVT occurrence
Previously treated symptomatic DVT in target vein within past 12 months
Contralateral leg symptomatic DVT likely requiring surgery within 30 days
Limb-threatening circulatory compromise with specified low ankle or toe pressures
Massive or intermediate high-risk pulmonary embolism
Inability to tolerate venous intervention due to severe illness
Allergy or hypersensitivity to heparin, rtPA, dexamethasone, or iodinated contrast (except mild-moderate contrast allergies with premedication)
History or active heparin-induced thrombocytopenia
Low hemoglobin, platelets, or abnormal coagulation before anticoagulation
Active bleeding or recent severe bleeding events
Recent major surgeries or invasive procedures within specified timeframes
History of hemorrhagic stroke or intracranial bleeding conditions
Active cancer with life expectancy less than 2 years
Severe unstable hypertension
Pregnant or breastfeeding
Life expectancy less than 2 years
Thrombus extending above common iliac confluence
Inability to obtain venous access or recanalize target vein
History of ipsilateral venous stent
DVT length exceeding 50 cm for drug therapy target

Research Team

Kirk Seward, PhD

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