Anti-Inflammatory shot near veins may stop blood clots from coming back
NCT ID NCT04858776
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests whether delivering the anti-inflammatory drug dexamethasone directly around deep veins can prevent blood clots from returning after they are removed. The study involves 60 adults aged 18-89 who have had DVT symptoms for 14-60 days. Participants receive either dexamethasone or a saline placebo via a special catheter, and are followed for up to 24 months to check for re-clotting and symptom improvement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dexamethasone
- What this could lead to
- If it works, this could offer a way to prevent blood clots from returning after treatment for deep vein thrombosis, reducing long-term complications.
- What could go wrong
- This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. The procedure involves risks like bleeding or infection, and the drug may not prevent re-thrombosis as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2022
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CIS Clinical Research
Houma, Louisiana, 70360, United States
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CardioVoyage
Denison, Texas, 75020, United States
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Galway University Hospital
Galway, H91 YR71, Ireland
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Guy's and St. Thomas Hospital
London, SE1 7EH, United Kingdom
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Lake Washington Vascular
Bellevue, Washington, 98004, United States
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Medstar Health Research Institute
Hyattsville, Maryland, 20782, United States
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NC Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
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Northwestern University Hospital
Chicago, Illinois, 60611, United States
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OhioHealth Research Institute
Columbus, Ohio, 43214, United States
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Sentara Norfolk General Hospital
Norfolk, Virginia, 23452, United States
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St John Health System
Bartlesville, Oklahoma, 74006, United States
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Stony Brook University Hospital
Stony Brook, New York, 11794, United States
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University of South Florida
Tampa, Florida, 33060, United States
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University of Texas, Houston
Houston, Texas, 77494, United States
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Vascular Care Connecticut
Darien, Connecticut, 06820, United States