Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
NCT ID: NCT04862468
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2021-10-29
2028-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment
Perivascular dexamethasone
Dexamethasone delivery around target vein segment(s)
Control
Perivascular sham
Saline delivery around target vein segment(s)
Interventions
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Perivascular dexamethasone
Dexamethasone delivery around target vein segment(s)
Perivascular sham
Saline delivery around target vein segment(s)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
89 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Mercator MedSystems, Inc.
INDUSTRY
Responsible Party
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Locations
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Providence St. Joseph Hospital
Orange, California, United States
Vascular Care Connecticut
Darien, Connecticut, United States
HCA Florida JFK Hospital
Atlantis, Florida, United States
Baptist Health
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
CIS Clinical Research
Houma, Louisiana, United States
Medstar Health Research Institute
Hyattsville, Maryland, United States
Englewood Health
Englewood, New Jersey, United States
Stony Brook University Hospital
Stony Brook, New York, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
OhioHealth Research Institute
Columbus, Ohio, United States
St John Health System
Bartlesville, Oklahoma, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Galway University Hospital
Galway, , Ireland
Guy's and St. Thomas Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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CIP0217
Identifier Type: -
Identifier Source: org_study_id
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