What is dexamethasone studying for deep vein thrombosis in this trial?

This trial studies whether delivering dexamethasone, an anti-inflammatory drug, locally around veins after clot removal can help prevent new clots and improve symptoms in patients with deep vein thrombosis. The research aims to understand if reducing inflammation after the procedure provides lasting benefits. Mercator MedSystems, Inc. is leading this study to explore this treatment approach.

Who may be eligible for this deep vein thrombosis clinical trial?

Adults aged 18 to 89 with recent deep vein thrombosis symptoms (within 14 days) who have had successful clot removal may be eligible. Both men and women can participate, but women of reproductive potential must use effective contraception. Participants must be able to take oral medication and follow anticoagulant treatment. Please review eligibility criteria for more details.

Is there any cost to participate in this deep vein thrombosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan for possible out-of-pocket costs related to attending study visits.

Actively Recruiting

Phase 2

Age: 18Years - 89Years

All Genders

ID04862468

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

Led by Mercator MedSystems, Inc. · Updated on 2025-07-04

Participants Needed

Research Sites

78 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a medical procedure that uses a commercially available catheter called the Bullfrog Micro-Infusion Device to deliver an anti-inflammatory drug, dexamethasone sodium phosphate injection, locally around deep veins after removing blood clots DVT recanalization. This study focuses on patients who had deep vein thrombosis symptoms for up to 14 days before the initial clot removal. The goal is to determine if reducing local inflammation can help prevent new clots from forming and improve symptoms for up to 24 months after treatment. Participants receive either the anti-inflammatory drug dexamethasone delivered around the target vein segment or a saline solution as a comparison, both using the same device. This is a randomized, quadruple-masked trial where neither the participants, care providers, investigators, nor outcomes assessors know which treatment is given. The study includes treatment of acute femoropopliteal DVT located in major veins of the leg, with successful clot removal prior to treatment. The study treatment is combined with prescribed anticoagulant and antiplatelet medications for up to 12 months post-procedure. During the study, participants will complete questionnaires and attend follow-up visits to monitor their condition and treatment effects. Researchers will assess outcomes including the rate of keeping the vein open primary patency at 6 months, prevention of post-thrombotic syndrome progression at 6 months, and freedom from major adverse events at 30 days. Participants will be followed for up to 24 months to evaluate long-term benefits and safety of the treatment.

CONDITIONS

Brief Title

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT

Who Can Participate

Age: 18Years - 89Years

All Genders

Eligibility Criteria

You may qualify if you...

Provision of signed informed consent before any non-standard procedures
Willingness to comply with all study procedures and follow-up visits
Male or female aged 18 to 89 years
For females of reproductive potential, use of effective contraception for at least 1 month before and 30 days after treatment
Onset of acute DVT symptoms 14 days or less before initial intervention in the study limb
Ability to take oral medication and willingness to follow anticoagulant regimen
Post-procedure prescription for low molecular weight heparin for at least 28 days followed by anticoagulant therapy for at least 12 months
Minimum 28 days of antiplatelet agent for patients receiving stents
DVT located in major femoropopliteal veins with possible iliac vein extension
Successful recanalization of the target vein with removal of acute thrombus

You will not qualify if you...

Enrollment in another non-registry clinical study that has not completed its primary endpoint
Inability to understand the nature and implications of the trial
Body Mass Index between 40 and 45 with significant comorbidity or above 45
Non-ambulatory before DVT occurrence
Current established post-thrombotic syndrome or symptomatic deep venous insufficiency in the study leg
Symptomatic DVT in the opposite leg requiring surgery within 30 days
Limb-threatening circulatory compromise with very low ankle or toe pressures
High-risk pulmonary embolism
Severe dyspnea or acute systemic illness preventing venous intervention
Allergy or hypersensitivity to planned drugs except mild contrast allergies
History or active heparin-induced thrombocytopenia
Low hemoglobin, high INR, or low platelets
Severe renal impairment
Active or recent bleeding or bleeding disorders
Recent major surgery or trauma affecting follow-up
Recent childbirth within 72 hours
Recent hemorrhagic stroke or intracranial/spinal bleeding or tumors
Active symptomatic COVID-19 infection affecting follow-up
Severe uncontrolled hypertension
Pregnancy or breastfeeding
Life expectancy less than 2 years
Major thrombus extending above common iliac vein
Inability to obtain venous access or recanalize target vein
History of ipsilateral venous stent
DVT target length over 50 cm

Research Team

Kirk Seward, PhD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here