RecruitingPHASE2INTERVENTIONAL

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

This study is investigating a new way to treat deep vein thrombosis (DVT) in the leg. After a blood clot is removed, a small device is used to deliver an anti-inflammatory medicine called dexamethasone directly around the affected vein. Researchers want to find out if giving this medicine locally helps prevent new blood clots from forming and reduces DVT symptoms over a two-year period. It focuses on people who have had DVT symptoms for up to 14 days before their clot was removed. This is a Phase 2 study, meaning it's still in the earlier stages of testing to see if the treatment is safe and effective.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Mercator MedSystems, Inc.

Enrolment target

Start

29 Oct 2021

Estimated completion

01 Feb 2028

Thrombosis, Deep Vein Iliofemoral; Thrombosis

What is this study about?

This study is looking into a condition called Deep Vein Thrombosis, or DVT. This happens when a blood clot forms in a deep vein, often in the leg. While doctors can remove these clots, there's a risk they might come back, and symptoms can linger. This research aims to find a way to make the treatment more effective by focusing on reducing inflammation (swelling) around the vein after the clot has been taken out. Doctors believe that by calming this inflammation, they might be able to prevent new clots from forming and help people feel better for longer.

The main idea behind the study is to use an existing anti-inflammatory medication, called dexamethasone, in a very targeted way. Instead of taking it as a pill or injection that affects the whole body, a special tool is used to deliver this medicine directly around the treated vein. This local approach means the medicine can work right where it's needed with potentially fewer side effects. The study will follow participants for up to two years to see if this local anti-inflammatory treatment helps keep the vein clear and improves their recovery.

Participants in the study will be people who have recently had a blood clot removed from a major vein in their leg (specifically the femoropopliteal veins, which are in the thigh and behind the knee). The study is in its early stages (Phase 2), which means researchers are still gathering information on how well it works and its safety. The hope is that this new approach could lead to better long-term outcomes for people who experience DVT.

Key takeaways

This study is testing a new way to deliver anti-inflammatory medicine for DVT.
The medicine (dexamethasone) is given directly around the vein after clot removal.
The goal is to prevent new clots and improve long-term symptoms.
Participation involves special procedures, medication, and follow-up for up to 2 years.
This is an early-stage study (Phase 2) to check safety and how well it works.

Who may be eligible?

To join this study, you would generally need to be an adult between 18 and 89 years old. A key requirement is that your DVT symptoms started within 14 days before the blood clot was removed from your leg, and the procedure to clear the clot must have been successful.

You also need to be able to take medication by mouth and agree to follow a specific plan for anti-clotting medicines after your procedure. Your DVT should be in certain large veins in your leg, like those in your thigh and behind your knee. For women who could become pregnant, effective contraception is required for a period before and after the study treatment.

There are also reasons why you might not be able to join. For instance, if you're already in another study testing a new drug or device, or if your body mass index (BMI) is very high and the doctors think it could interfere with the study. The medical team will check carefully to make sure the study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 89 years old?
Did your DVT symptoms start within 14 days before your clot was removed?
Was your blood clot successfully removed from a major leg vein?
Are you able to take prescribed oral medications and follow a treatment plan?
For women, are you using effective birth control, or are you past childbearing age?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first need to sign a consent form, which means you understand what's involved and agree to participate. You'll have several visits and questionnaires to complete over time. The study involves a medical procedure where a special tool is used to deliver the anti-inflammatory medicine directly around your treated vein after your blood clot has been removed. You'll also need to take specific anti-clotting medications for at least 12 months, and if you have a stent, you'll take anti-platelet medicine for at least 28 days.

The study will follow you closely to monitor your progress and see if the treatment is working. This will involve regular check-ups and assessments. The total duration of your involvement in the study could be up to 24 months (two years) to see the long-term effects of the treatment.

Potential risks and benefits

Participating in this study might offer the potential benefit of a local treatment that could help prevent new blood clots and improve your DVT symptoms for longer. However, as with any medical procedure or new treatment, there are potential risks. These could include risks related to the procedure itself, or possible side effects from the study medication, although delivering it locally aims to reduce overall body exposure. You will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (17)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Providence St. Joseph Hospital
Verified postcode
Orange, United States· Recruiting
Vascular Care Connecticut
Verified postcode
Darien, United States· Recruiting
HCA Florida JFK Hospital
Verified postcode
Atlantis, United States· Recruiting
Baptist Health
Verified postcode
Jacksonville, United States· Recruiting
University of South Florida
Verified postcode
Tampa, United States· Recruiting
Piedmont Heart Institute
Verified postcode
Atlanta, United States· Recruiting
CIS Clinical Research
Verified postcode
Houma, United States· Recruiting
Medstar Health Research Institute
Verified postcode
Hyattsville, United States· Recruiting
Englewood Health
Verified postcode
Englewood, United States· Recruiting
Stony Brook University Hospital
Verified postcode
Stony Brook, United States· Recruiting
NC Heart and Vascular Research
Verified postcode
Raleigh, United States· Recruiting
OhioHealth Research Institute
Verified postcode
Columbus, United States· Active not recruiting

Common questions

What is DVT?

DVT stands for Deep Vein Thrombosis. It's a condition where a blood clot forms in a deep vein, usually in the leg, which can cause swelling and pain.

What is dexamethasone?

Dexamethasone is a common medicine used to reduce swelling and inflammation in the body. In this study, it's given directly around the treated vein.

Will I know if I'm getting the active medicine or a 'sham' treatment?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you receive the active medicine or the 'sham' (a dummy treatment) until after the study is complete. This helps ensure fair and accurate results.

How long will I be followed in this study?

You will be followed by the study team for up to two years to see the long-term effects of the treatment.

Can I stop participating in the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.

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.