Your session is about to expire
← Back to Search
Corticosteroid
Perivascular Dexamethasone for Iliofemoral Thrombosis (DEXTERITY-SCI Trial)
Phase 2
Recruiting
Research Sponsored by Mercator MedSystems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Successful recanalization of the target vein with at least one patent inflow vein (femoral or profunda)
Hemodynamically significant DVT (>50% area obstruction) spanning at least (a) the iliofemoral and common femoral veins or (b) the common femoral vein with extension into the femoral vein and/or profunda vein. Extent of thrombus in the popliteal and calf veins is allowed
Must not have
Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis
Non-ambulatory status prior to DVT occurrence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Summary
This trial is testing whether a local anti-inflammatory drug can help prevent re-thrombosis and improve symptoms for up to 24 months after a DVT recanalization procedure.
Who is the study for?
Adults aged 18-89 with recent (14-60 days) iliofemoral DVT needing stenting, able to take oral meds and adhere to anticoagulant regimen. Must not have active cancer, severe health issues, or be pregnant/breastfeeding. BMI must be under 40, and they should agree to contraception if applicable.
What is being tested?
The trial tests whether injecting dexamethasone around deep veins after DVT recanalization reduces re-thrombosis risk and improves symptoms over two years compared to a sham procedure using the Bullfrog® Micro-Infusion Device.
What are the potential side effects?
Possible side effects include local reactions at the infusion site, increased bleeding risk due to anti-inflammatory action of dexamethasone, potential for immune system suppression leading to higher infection rates.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My targeted vein was successfully reopened and has at least one working inflow vein.
Select...
I have a significant blood clot in my leg that blocks more than half of the blood flow.
Select...
I can take pills and will follow the blood thinner plan.
Select...
I am prescribed a blood thinner for at least 14 days, followed by another for a year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have active bleeding, recent severe GI issues, or serious liver problems.
Select...
I was not able to walk before my deep vein thrombosis happened.
Select...
I have a blood clot in my main vein that extends at least one centimeter above where my leg veins meet.
Select...
My blood clot is longer than 50 cm and needs drug treatment.
Select...
I understand what the clinical trial involves and its importance.
Select...
My high blood pressure is under control and below 140 mmHg.
Select...
My targeted vein segment cannot be reopened.
Select...
My doctor expects I have less than 2 years to live due to my cancer.
Select...
Your blood tests show low levels of hemoglobin or platelets, or your kidneys are not working well.
Select...
I have had a bleeding stroke or bleeding in my brain/spine.
Select...
I cannot undergo certain vein treatments due to severe shortness of breath or a sudden illness.
Select...
My leg circulation is severely compromised.
Select...
I have not had recent major surgery or eye problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinically relevant primary patency
Freedom from major adverse event (MAE)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Vascular Care ConnecticutUNKNOWN
1 Previous Clinical Trials
80 Total Patients Enrolled
University of South FloridaOTHER
425 Previous Clinical Trials
190,415 Total Patients Enrolled
OhioHealth Research InstituteUNKNOWN
2 Previous Clinical Trials
98 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a condition called heparin-induced thrombocytopenia in the past or are currently experiencing it.My targeted vein was successfully reopened and has at least one working inflow vein.I have been on aspirin or a P2Y12 inhibitor for at least 30 days.You have had a stent placed in a vein on the same side of your body as the treatment.I have a significant blood clot in my leg that blocks more than half of the blood flow.I do not have active bleeding, recent severe GI issues, or serious liver problems.I was not able to walk before my deep vein thrombosis happened.I have a blood clot in my main vein that extends at least one centimeter above where my leg veins meet.You have had a bad reaction to heparin, rtPA, dexamethasone sodium phosphate, or iodinated contrast, unless it was a mild or moderate reaction that can be managed with steroids beforehand.My blood clot is longer than 50 cm and needs drug treatment.I understand what the clinical trial involves and its importance.My high blood pressure is under control and below 140 mmHg.My targeted vein segment cannot be reopened.I can take pills and will follow the blood thinner plan.My doctor expects I have less than 2 years to live due to my cancer.I am prescribed a blood thinner for at least 14 days, followed by another for a year.I am between 18 and 89 years old.Your blood tests show low levels of hemoglobin or platelets, or your kidneys are not working well.I have a pulmonary embolism that is not considered low risk.My other leg has a blood clot that needs surgery within 30 days.You cannot have a needle put into your vein.I have had a bleeding stroke or bleeding in my brain/spine.You have a very high body mass index.You are not expected to live for more than 2 years.I cannot undergo certain vein treatments due to severe shortness of breath or a sudden illness.I am willing and able to follow all study requirements, including questionnaires and visits.I am not currently in a drug or device study, except for approved registry studies.I tested negative for COVID-19 recently or have been vaccinated/boosted in the last year.I started having DVT symptoms in my leg 14 to 60 days ago and need a stent.I had treatment for a painful blood clot in a vein within the last year.My leg circulation is severely compromised.I have not had recent major surgery or eye problems.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger