RecruitingPHASE2INTERVENTIONAL

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT

This research is investigating a new treatment for deep vein thrombosis (DVT), specifically in the hip and thigh area (iliofemoral DVT). When a blood clot is removed, the study delivers a common anti-inflammatory medicine called dexamethasone directly around the treated vein using a special device. The main goal is to see if this local treatment can help reduce inflammation, which might prevent new blood clots from forming in the same area. Researchers also want to find out if it improves symptoms for patients in the long term, over a period of up to two years after the initial procedure. This study focuses on people who have had DVT symptoms for 14 to 60 days before their clot was opened up.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Mercator MedSystems, Inc.

Enrolment target

Start

08 Aug 2022

Estimated completion

31 Dec 2026

Iliofemoral; Thrombosis

What is this study about?

This study is about a medical condition called Deep Vein Thrombosis (DVT), which is when a blood clot forms in a deep vein, usually in the leg. This particular study focuses on DVTs that occur in the hip and thigh area, known as iliofemoral DVT. When doctors remove these clots, they want to make sure the vein stays open and healthy.

The researchers are testing a new approach: after the blood clot has been removed, they use a special, small device to deliver a well-known anti-inflammatory medicine, dexamethasone, directly to the area around the treated vein. Think of it like targeting the swelling right where it happens. The idea is that by reducing inflammation in this specific spot, it might help prevent new clots from forming and could also lead to better long-term recovery for patients.

The main aim is to see if this local anti-inflammatory treatment helps keep the blood vessel clear and improves patients' symptoms over a period of two years. They are particularly interested in people who have had their DVT symptoms for between 14 and 60 days before having the clot removed.

Key takeaways

This study explores a new way to treat swelling after DVT clot removal.
A common anti-inflammatory drug is delivered directly to the treated vein.
The goal is preventing new clots and improving long-term symptoms.
Participation involves follow-up for up to two years.
It's for people with DVT in the hip/thigh area needing clot removal and a stent.

Who may be eligible?

To join this study, you need to be an adult between 18 and 89 years old. You must have experienced DVT symptoms in your hip or thigh area for at least two weeks but no more than two months before having treatment to open up the blood vessel. The DVT also needs to be affecting a significant part of your main leg veins and require a stent (a small tube to keep the vein open) in the hip/thigh area.

You must be able to take blood-thinning medicines as prescribed and attend all study appointments and follow-up visits. For women who could become pregnant, you'll need to have a negative pregnancy test and use reliable birth control during the study. You also need to have a recent negative COVID-19 test or be up-to-date with your COVID-19 vaccinations.

You won't be able to join if you are already taking part in another clinical study that tests new drugs or devices and hasn't finished its main part yet. If you have trouble understanding the study information, you also wouldn't be able to participate.

Quick self-check

Are you between 18 and 89 years old?
Did your DVT symptoms in your hip/thigh start 2 to 8 weeks ago?
Are you able and willing to take blood-thinning medications as prescribed?
Are you able to attend all study visits for up to two years?
For women, are you able to use reliable birth control during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will first need to sign a consent form, showing you understand and agree to the study plans. You will then undergo the procedure to remove your blood clot and receive the study treatment (either the anti-inflammatory medicine or a sham treatment).

After the procedure, you'll take prescribed blood-thinning medications for at least a year and an antiplatelet medicine for at least a month. You will need to complete questionnaires and attend regular follow-up visits with the study team. These visits will allow the doctors to check your progress and see how well the treatment is working. The study will track your health and symptoms for up to 24 months (two years) after your initial procedure.

Potential risks and benefits

Potential benefits of taking part might include receiving a treatment that could help reduce inflammation, prevent new blood clots, and improve your DVT symptoms more effectively than standard care. However, as this is a research study, there's no guarantee you will personally benefit. Potential risks are generally linked to the procedure itself, such as bleeding or infection, and reactions to the medicines used. The anti-inflammatory medicine also has potential side effects, although it's being given locally. You have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (15)

Vascular Care Connecticut
Darien, United States· Recruiting
University of South Florida
Tampa, United States· Recruiting
Northwestern University Hospital
Chicago, United States· Recruiting
CIS Clinical Research
Houma, United States· Recruiting
Medstar Health Research Institute
Hyattsville, United States· Recruiting
Stony Brook University Hospital
Stony Brook, United States· Not yet recruiting
NC Heart and Vascular Research
Raleigh, United States· Recruiting
OhioHealth Research Institute
Columbus, United States· Recruiting
St John Health System
Bartlesville, United States· Recruiting
CardioVoyage
Denison, United States· Recruiting
University of Texas, Houston
Houston, United States· Recruiting
Sentara Norfolk General Hospital
Norfolk, United States· Recruiting

+3 more sites — see the official record for the full list.

Common questions

What is DVT?

DVT stands for Deep Vein Thrombosis. It's a blood clot that forms in a deep vein, usually in the leg, which can block blood flow.

What is dexamethasone?

Dexamethasone is a common medicine used to reduce swelling and inflammation in the body.

Will I know if I'm getting the active treatment or the 'sham' (placebo)?

No, in this type of study, participants usually don't know whether they are receiving the active drug or the sham treatment. This helps ensure the results are unbiased.

How long will I be involved in the study?

Your involvement in the study will last for up to two years, with follow-up appointments and checks during that time.

What does 'iliofemoral DVT' mean?

This refers to a DVT that is located in the larger veins in your hip and thigh area.

How to find out more

Kirk Seward, PhD

kseward@mercatormed.com 510-614-4550 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.