RecruitingNAINTERVENTIONAL

DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis

This study, called DEFIANCE, is looking at the best ways to treat a specific type of blood clot in the leg called deep vein thrombosis (DVT). Patients taking part will be randomly assigned to one of two groups. One group will receive treatment using a special device called the ClotTriever System, which helps remove the blood clot. The other group will receive the usual care, which involves taking blood-thinning medicines like Heparin or Rivaroxaban. The researchers want to find out which treatment is better at clearing the clot and preventing long-term issues like pain and swelling. They will follow participants for six months to see how they are getting on.

At a glance

Status

Recruiting

Phase

Sponsor

Inari Medical

Enrolment target

300

Start

06 Jan 2023

Estimated completion

15 Jan 2027

Venous Thromboembolism Deep Venous Thrombosis Post-Thrombotic Syndrome

What is this study about?

When you have a deep vein thrombosis (DVT), it means a blood clot has formed in a deep vein, usually in your leg. This can be serious and sometimes lead to long-term problems like pain and swelling, known as Post-Thrombotic Syndrome. This study aims to find the most effective treatment for DVT, focusing on clots in the upper part of the leg veins.

The study will compare two approaches. One group of patients will have a procedure using a device called the ClotTriever System. This system is designed to remove the blood clot from the vein, helping the blood flow normally again. The other group will receive the standard treatment, which involves taking blood-thinning medicines. These medicines help stop the clot from growing and prevent new clots from forming, giving your body time to naturally dissolve the existing clot.

By comparing these two treatments, doctors hope to learn which method is better at clearing the clot and preventing the long-term problems that DVT can cause. This could help improve care for many people with DVT in the future.

Key takeaways

Compares a new clot-removal device (ClotTriever) with standard blood thinners for DVT.
Aims to find the best way to clear clots and prevent long-term DVT problems.
Participants will be randomly assigned to one of two treatment groups.
Study involves regular check-ups and follow-up over six months.
Could help improve future care for people with DVT.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have a DVT in a specific part of one of your upper leg veins (common femoral, external iliac, or common iliac veins). Your symptoms must have started within the last 12 weeks and be significant enough to impact your daily life. You also need to be able to understand the study and agree to take part.

You wouldn't be able to join if you have DVT in both legs, or if you already have a stent (a small tube to keep the vein open) in the affected vein. Other reasons you might not be eligible include having severe medical conditions, certain blood problems, or if you've recently had a DVT procedure or are taking part in another study that might affect this one. Doctors will carefully check all these points to make sure the study is safe and suitable for you.

Quick self-check

Are you 18 years old or older?
Do you have a DVT in one leg, in one of the main leg veins?
Did your DVT symptoms start within the last 12 weeks?
Are your DVT symptoms significant, causing noticeable problems?
Do you have any severe health issues that might stop you from having a procedure or taking strong medicines?
Are you able to agree to take part and attend follow-up appointments?

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

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups, like flipping a coin. You will either receive treatment with the ClotTriever System or take blood-thinning medication. The specific treatments you receive will depend on which group you are in. You will have regular check-ups and assessments, including scans and discussions about your symptoms, to see how you are responding to the treatment.

Over the course of six months, the study team will collect information about your health, any other medical conditions you have, details about your DVT diagnosis, and how well your treatment is working. This will involve several visits to the clinic for follow-up appointments. The overall duration of your active participation will be these six months.

Potential risks and benefits

Participating in this study might offer a chance to receive an advanced treatment for DVT, which could potentially improve your recovery and reduce long-term problems. However, as with any medical procedure or medication, there are potential risks, such as bleeding, infection, or reactions to medication. Everyone in the study will be closely monitored for any problems. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (64)

Honor Health
Scottsdale, United States· Recruiting
Pima Heart and Vascular
Tucson, United States· Recruiting
UCI Medical Center
Orange, United States· Recruiting
Vascular and Interventional Specialists of Orange County
Orange, United States· Recruiting
Huntington Health
Pasadena, United States· Recruiting
University Of Colorado
Denver, United States· Recruiting
Yale University
New Haven, United States· Recruiting
MedStar Health Research Institution
Washington D.C., United States· Recruiting
Manatee Memorial Hospital
Bradenton, United States· Terminated
Baptist Health Research Institute
Jacksonville, United States· Recruiting
Lakeland Vascular Institute
Lakeland, United States· Terminated
HCA Florida Largo Hospital
Largo, United States· Recruiting

+52 more sites — see the official record for the full list.

Common questions

What is DVT?

DVT stands for Deep Vein Thrombosis, which is a blood clot in a deep vein, usually in the leg.

What is the ClotTriever System?

It's a special device used in a procedure to remove blood clots from veins.

What are 'blood-thinning medicines'?

These are medicines, also called anticoagulants, that help stop blood clots from forming or growing larger.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of two groups, and you won't know which treatment you are receiving until after the randomisation.

How long will the study last for me?

Your participation will involve follow-up visits for six months after your treatment starts.

How to find out more

Kevin Wilhelmi

kevin.wilhelmi@stryker.com 602-578-0738 Official trial record

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