Perivenous Dexamethasone for Deep Vein Thrombosis
This study is looking at a new way to treat deep vein thrombosis (DVT), which is a blood clot in a deep vein. It tests whether delivering dexamethasone (an anti-inflammatory medicine) around the affected vein after removing the clot helps prevent new clots and improve symptoms. The medicine is delivered using a special catheter called the Bullfrog® Micro-Infusion Device. You may be able to join if you are between 18 and 89 years old and have had DVT symptoms for up to 14 days before clot removal. The study will measure if this treatment keeps the vein open, prevents a condition called post-thrombotic syndrome (PTS), and avoids serious side effects. The study is currently unclear on its recruitment status and plans to enroll 80 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 80 participants aged 18 to 89.
- What's involved
- You will need to sign a consent form, follow all study procedures, complete questionnaires, and attend follow-up visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for up to 24 months after the initial DVT recanalization procedure, with primary outcomes measured at 6 months and 30 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
At a glance
Conditions
NCT04862468
Where you'd take part
This study runs at 17 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Allegheny General Hospital
Pittsburgh, Pennsylvaniano site contact published
Recruiting
Baptist Health
Jacksonville, Floridano site contact published
Recruiting
CIS Clinical Research
Houma, Louisianano site contact published
Recruiting
Englewood Health
Englewood, New Jerseyno site contact published
Recruiting
HCA Florida JFK Hospital
Atlantis, Floridano site contact published
Recruiting
Medstar Health Research Institute
Hyattsville, Marylandno site contact published
Recruiting
NC Heart and Vascular Research
Raleigh, North Carolinano site contact published
Recruiting
Piedmont Heart Institute
Atlanta, Georgiano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Rate of clinically relevant primary patency6 months
Rate of freedom from loss of patency (defined as 100% occlusion of unstented vein or 50% stenosis of stented vein measured by duplex ultrasound or angiogram) with associated symptoms
- Limit the progression to PTS6 months
PTS rate by Villalta score ≥5.
- Rate of freedom from major adverse event (MAE)30 days
Rate of freedom from composite of all-cause death, clinically significant pulmonary embolism, major bleeding, target vessel thrombosis, infection of treatment or insertion site, or AV fistula of treatment site