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Using dexamethasone to reduce inflammation after blood clot removal in the leg

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT (DEXTERITY-AFP)

Phase 2 Interventional Mercator MedSystems, Inc. · NCT04862468

This study is testing if giving dexamethasone directly around the veins after removing a blood clot can help reduce inflammation and improve symptoms for people with deep vein thrombosis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years to 89 Years
SexAll
SponsorMercator MedSystems, Inc. Industry-sponsored
Locations17 sites (Orange, California and 16 other locations)
Trial IDNCT04862468 on ClinicalTrials.gov

What this trial studies

This study investigates the use of a catheter to deliver dexamethasone, an anti-inflammatory medication, directly around deep veins following the removal of a blood clot (DVT). The aim is to determine if this localized treatment can reduce inflammation and prevent the recurrence of thrombosis, as well as improve symptoms for up to 24 months post-procedure. Participants will be monitored for their response to the treatment and any changes in their condition over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 89 who have experienced acute DVT symptoms for 14 days or less prior to treatment.

Not a fit: Patients with chronic DVT symptoms or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of re-thrombosis and improve long-term outcomes for patients with DVT.

How similar studies have performed: While the specific approach of localized dexamethasone delivery is novel, similar anti-inflammatory treatments have shown promise in other studies.

Eligibility criteria

Show full inclusion / exclusion 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: use of highly effective contraception (abstinence is acceptable) for at least 1 month prior to study treatment (unless they had given birth within the 1 month prior to study treatment), and agreement to use such a method for at least 30 days after study treatment.
5. Onset of acute DVT symptoms of 14 days or less prior to initial intervention in the study limb.
6. Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen.
7. Post-procedural prescription for at least 28 days low molecular weight heparin followed by therapeutic anticoagulant of investigator's choice for 12 months minimum as part of post-interventional medication regimen.
8. Minimum of 28 days of prescribed antiplatelet agent (aspirin or P2Y12 inhibitor) for patients receiving stents.
9. DVT located in any of the major femoropopliteal veins (common femoral, femoral, and/or popliteal above the tibial plateau), with possible extension downstream into the iliac veins.
10. Successful recanalization of the target vein with removal of acute thrombus.

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 between 40 kg/m2 and 45 kg/m2, with significant comorbidity which, in the Investigator's discretion, could impair follow-up or study outcomes.
4. Body Mass Index \> 45 kg/m2.
5. Non-ambulatory status prior to DVT occurrence.
6. In the study leg: current established PTS (Villalta ≥ 5 for more than 14 days), current known symptomatic deep venous insufficiency for more than 14 days, or previous symptomatic DVT within the last 365 days.
7. In the contralateral (non-study) leg: symptomatic DVT that, in the opinion of the operating physician, will require a subsequent open or endovascular surgery in the following 30 days.
8. In cases with symptoms of limb-threatening circulatory compromise, ankle-brachial index \<0.4, absolute ankle pressure \<50 mmHg or absolute toe pressure \<30 mmHg.
9. 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.
10. Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.
11. Allergy or hypersensitivity to any drugs planned for use in the case (including dexamethasone sodium phosphate, iodinated contrast, low molecular-weight heparin, or recombinant tissue plasminogen activator, rtPA, if planned), except for mild-moderate contrast allergies for which steroid pre-medication can be used.
12. History of, or active heparin-induced thrombocytopenia (HIT).
13. Hemoglobin \< 8.0 g/dl.
14. INR \> 1.6 before starting anticoagulation.
15. Platelets \< 100,000/ml.
16. Severe renal impairment (estimated glomerular filtration rate \< 30 ml/min).
17. Active bleeding, recent (\< 1 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
18. Recent (\< 3 mo) internal eye surgery or hemorrhagic retinopathy.
19. Recent (\< 10 days) major surgery, trauma, cardiopulmonary resuscitation, or other invasive procedure which, in the Investigator's discretion, could impair follow-up or study outcomes.
20. Obstetrical delivery \<72 hours prior to procedure.
21. Hemorrhagic stroke within the last 365 days.
22. Intracranial/intraspinal bleed within the last 365 days.
23. Intracranial/intraspinal tumor within the last 365 days.
24. Intracranial/intraspinal vascular malformation within the last 365 days.
25. Intracranial/intraspinal aneurysm within the last 365 days.
26. Active symptomatic COVID-19 infection that, in the Investigator's discretion, could impair follow-up or study outcomes.
27. 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).
28. Pregnant or breastfeeding.
29. Life expectancy \< 2 years (e.g. due to active cancer).
30. Major thrombus of the inferior vena cava (IVC) (occlusive or near-occlusive) extending at least one centimeter above the common iliac confluence.
31. Inability to obtain venous access.
32. Inability to recanalize the target vein segment with less than 30% residual obstruction due to thrombus.
33. History of ipsilateral venous stent.
34. DVT target length intended for drug treatment exceeds 50 cm.

Where this trial is running

Orange, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Thrombosis, Deep VeinIliofemoralThrombosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.