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ACTIVE NOT RECRUITINGPhase2

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

Sponsor: Mercator MedSystems, Inc.

NCT ID: NCT04858776

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Perivascular dexamethasone (combination product), Perivascular sham (combination product)
How long the study runs
Study runs about 57 months (dates as stated)
About the drug or intervention
Perivascular dexamethasone — combination product: Dexamethasone delivery around target vein segment(s) · Perivascular sham — combination product: Saline delivery around target vein segment(s)
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 89 Years
Who
All
Number of participants
60
Started
2022-08-08
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for iliofemoral; thrombosis
  • • Phase2 - 60 participants
  • • This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for at least 14 days and no more than 60 days prior to recanalization

Who can take part?

  • • Ages 18 Years to 89 Years
  • • Diagnosed with iliofemoral; thrombosis

Where?

  • • London - Guy's and St. Thomas Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for at least 14 days and no more than 60 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure.

Iliofemoral; Thrombosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 89 Years
  • Who can join: All genders

What the study is looking for

  • ✓Provision of signed and dated agreement to take part form prior to receiving any non-the usual treatment, protocol-specific...
  • ✓Stated willingness to comply with all study procedures including completion of questionnaires and follow-up visits...
  • ✓Male or female, aged 18 to 89 years.
  • ✓Negative COVID-19 test result within 5 days prior to procedure or evidence of COVID-19 vaccine or booster within...
  • ✓Onset of DVT symptoms 14 to 60 days prior to intervention in the study limb with need for stenting of the...

Who cannot take part

  • ✗Lack of capability of understanding the nature, significance and implications of the clinical trial.
  • ✗Body Mass Index \> 40 kg/m2.
  • ✗Non-ambulatory status prior to DVT occurrence.
  • ✗In the target vein segment: previously treated causing symptoms DVT within the previous 12 months.
  • ✗In the contralateral (non-study) leg: causing symptoms DVT that, in the opinion of the operating physician, will require...
See the full criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form prior to receiving any non-standard of care, protocol-specific procedures. 2. Stated willingness to comply with all study procedures including completion of questionnaires and follow-up visits and availability for the duration of the study. 3. Male or female, aged 18 to 89 years. 4. For females of reproductive potential: negative pregnancy test ≤7 days before the procedure, use of highly effective contraception for at least 1 month prior to screening, and agreement to use such a method during study participation. 5. Negative COVID-19 test result within 5 days prior to procedure or evidence of COVID-19 vaccine or booster within past 12 months. 6. Onset of DVT symptoms 14 to 60 days prior to intervention in the study limb with need for stenting of the iliofemoral segment. 7. Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen. 8. Prescription for at least 14 days low molecular weight heparin followed by therapeutic anticoagulant of investigator's choice for 12-month minimum as part of post-interventional medication regimen. 9. Minimum of 30 days of prescribed antiplatelet agent (aspirin or P2Y12 inhibitor). 10. Hemodynamically significant DVT (\>50% area obstruction) spanning at least (a) the iliofemoral and common femoral veins or (b) the common femoral vein with extension into the femoral vein and/or profunda vein. Extent of thrombus in the popliteal and calf veins is allowed. 11. Successful recanalization of the target vein with at least one patent inflow vein (femoral or profunda). Exclusion Criteria: 1. Current enrollment in another non-registry clinical study of systemic drug therapy or another device study that has not completed its primary endpoint, including prior enrollment in this study. Concurrent enrollment in registry studies of approved devices or drugs are acceptable. 2. Lack of capability of understanding the nature, significance and implications of the clinical trial. 3. Body Mass Index \> 40 kg/m2. 4. Non-ambulatory status prior to DVT occurrence. 5. In the target vein segment: previously treated symptomatic DVT within the previous 12 months. 6. In the contralateral (non-study) leg: symptomatic DVT that, in the opinion of the operating physician, will require surgery in the following 30 days. 7. Limb-threatening circulatory compromise with ankle-brachial index \<0.4, absolute ankle pressure \<50 mmHg or absolute toe pressure \<30 mmHg. 8. Pulmonary embolism (PE) defined as either massive (Systolic blood pressure \< 90 mmHg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high-risk PE, as defined by the European Society Guideline on management of PE. Low-risk PE and/or intermediate low-risk PE can be enrolled. 9. Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness. 10. Allergy, hypersensitivity, or thrombocytopenia from heparin, Recombinant tissue plasminogen activator (rtPA), dexamethasone sodium phosphate or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used. 11. History of, or active heparin-induced thrombocytopenia (HIT). 12. Haemoglobin \< 9.0 mg/dl, INR \> 1.6 before starting anticoagulation, or platelets \< 100,000/ml. Moderate renal impairment in diabetic patients (estimated glomerular filtration rate \< 60 ml/min) or severe renal impairment in non-diabetic patients (estimated glomerular filtration rate \< 30 ml/min). 13. Active bleeding, recent (\< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis. 14. Recent (\< 3 mo) internal eye surgery or haemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, obstetrical delivery, or other invasive procedure. 15. History of hemorrhagic stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm. 16. Active cancer with a life expectancy of \<2 years. 17. Severe hypertension on repeated readings (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 105 mmHg). This can be treated, and blood pressure must be stable before venous access is obtained (systolic blood pressure \<140 mmHg). 18. Pregnant or breastfeeding. 19. Life expectancy \< 2 years. 20. Thrombus of the inferior vena cava (IVC) extending at least one centimeter above the common iliac confluence. 21. Inability to obtain venous access. 22. Inability to recanalize the target vein segment(s). 23. History of ipsilateral venous stent. 24. DVT length to be targeted for perivascular drug therapy exceeds 50 cm.

Where Is This Study? (1 UK site)

Guy's and St. Thomas Hospital

London SE1 7EH, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a
Data sourced from ClinicalTrials.gov · Last verified: 2026-06