Actively Recruiting
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT
Led by Mercator MedSystems, Inc. · Updated on 2023-10-18
60
Participants Needed
15
Research Sites
229 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures.
- Willingness to follow all study procedures, complete questionnaires, and attend follow-up visits.
- Male or female, aged 18 to 89 years.
- For females of reproductive potential: negative pregnancy test within 7 days before procedure and use of effective contraception for at least 1 month before screening and during study.
- Negative COVID-19 test within 5 days before procedure or proof of COVID-19 vaccination/booster within past 12 months.
- Onset of DVT symptoms 14 to 60 days before intervention with need for iliofemoral stenting.
- Ability to take oral medication and willingness to follow prescribed anticoagulant regimen.
- Prescription for at least 14 days of low molecular weight heparin followed by 12 months of therapeutic anticoagulant.
- At least 30 days of prescribed antiplatelet agent (aspirin or P2Y12 inhibitor).
- Hemodynamically significant DVT (>50% area obstruction) involving iliofemoral and common femoral veins or common femoral vein with extension.
- Successful recanalization of target vein with at least one patent inflow vein (femoral or profunda).
You will not qualify if you...
- Currently enrolled in another non-registry clinical study or previously enrolled in this study.
- Unable to understand the trial's nature and implications.
- Body Mass Index over 40 kg/m2.
- Non-ambulatory before DVT occurrence.
- Previously treated symptomatic DVT in target vein segment within 12 months.
- Symptomatic DVT in contralateral leg requiring surgery within 30 days.
- Limb-threatening circulatory compromise with ankle-brachial index <0.4 or low ankle/toe pressures.
- Massive or intermediate high-risk pulmonary embolism.
- Inability to tolerate venous intervention due to severe dyspnea or acute illness.
- Allergy or hypersensitivity to heparin, rtPA, dexamethasone sodium phosphate, or iodinated contrast (except mild contrast allergies with pre-medication).
- History or active heparin-induced thrombocytopenia.
- Low hemoglobin (<9.0 mg/dl), high INR (>1.6), or low platelets (<100,000/ml); moderate or severe renal impairment.
- Active bleeding or recent severe bleeding events.
- Recent major surgery, trauma, or invasive procedures within specified timeframes.
- History of hemorrhagic stroke or intracranial bleeding.
- Active cancer with life expectancy under 2 years.
- Severe hypertension unless controlled and stable.
- Pregnant or breastfeeding.
- Life expectancy less than 2 years.
- Thrombus in inferior vena cava extending above common iliac confluence.
- Inability to obtain venous access or recanalize target vein.
- History of ipsilateral venous stent.
- DVT length targeted exceeds 50 cm.
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Vascular Care Connecticut
Darien, Connecticut, United States, 06820
Actively Recruiting
2
University of South Florida
Tampa, Florida, United States, 33060
Actively Recruiting
3
Northwestern University Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
4
CIS Clinical Research
Houma, Louisiana, United States, 70360
Actively Recruiting
5
Medstar Health Research Institute
Hyattsville, Maryland, United States, 20782
Actively Recruiting
6
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Not Yet Recruiting
7
NC Heart and Vascular Research
Raleigh, North Carolina, United States, 27607
Actively Recruiting
8
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
9
St John Health System
Bartlesville, Oklahoma, United States, 74006
Actively Recruiting
10
CardioVoyage
Denison, Texas, United States, 75020
Actively Recruiting
11
University of Texas, Houston
Houston, Texas, United States, 77494
Actively Recruiting
12
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23452
Actively Recruiting
13
Lake Washington Vascular
Bellevue, Washington, United States, 98004
Actively Recruiting
14
Galway University Hospital
Galway, Ireland, H91 YR71
Actively Recruiting
15
Guy's and St. Thomas Hospital
London, United Kingdom, SE1 7EH
Actively Recruiting
Research Team
K
Kirk Seward, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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