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Anti-Inflammatory shot near veins may stop blood clots from coming back

NCT ID NCT04858776

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

Anyone

Healthy volunteers

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

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

  • CIS Clinical Research

    Houma, Louisiana, 70360, United States

  • CardioVoyage

    Denison, Texas, 75020, United States

  • Galway University Hospital

    Galway, H91 YR71, Ireland

  • Guy's and St. Thomas Hospital

    London, SE1 7EH, United Kingdom

  • Lake Washington Vascular

    Bellevue, Washington, 98004, United States

  • Medstar Health Research Institute

    Hyattsville, Maryland, 20782, United States

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607, United States

  • Northwestern University Hospital

    Chicago, Illinois, 60611, United States

  • OhioHealth Research Institute

    Columbus, Ohio, 43214, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23452, United States

  • St John Health System

    Bartlesville, Oklahoma, 74006, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • University of South Florida

    Tampa, Florida, 33060, United States

  • University of Texas, Houston

    Houston, Texas, 77494, United States

  • Vascular Care Connecticut

    Darien, Connecticut, 06820, United States