RecruitingNAINTERVENTIONAL

RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)

This research is looking into a new treatment called the Recana Thrombectomy Catheter System. It's designed for people who have ongoing problems with their leg veins being blocked due to past blood clots. These blockages can cause uncomfortable symptoms like swelling or pain. The main goal of the study is to find out if this new device is both safe to use and good at opening up these blocked veins. Doctors will check for any reactions to the treatment in the first 30 days and measure how well the device opens up the vein during the procedure. Participants will be carefully monitored for a year after their treatment to see how they are doing and if their symptoms improve, giving valuable information about this potential new method for improving vein health.

At a glance

Status

Recruiting

Phase

Sponsor

Intervene, Inc.

Enrolment target

Start

18 Oct 2025

Estimated completion

01 Jul 2027

Venous Obstruction

What is this study about?

This clinical study is investigating a new treatment for a condition called venous obstruction. This happens when blood vessels, particularly in the legs, become narrowed or blocked, often because of a previous blood clot (thrombosis). When these veins are blocked, it can lead to uncomfortable symptoms like swelling, pain, and discomfort. The new treatment being tested is called the Recana Thrombectomy Catheter System, which is a specialised device designed to clear these blockages and help blood flow more freely.

The main aim of this study is to understand if the Recana system is a safe and effective way to treat these long-standing blockages in the veins. Researchers will be looking at two key things: firstly, the safety of the procedure, by carefully tracking any problems or side effects that happen within the first 30 days after treatment. Secondly, they will measure how well the device opens up the blocked vein during the procedure itself. This information is crucial for doctors to determine if this new system could become a valuable option for people experiencing these venous problems, potentially improving their quality of life.

By taking part, individuals would help doctors learn more about this innovative treatment. The study is particularly interested in people who continue to experience symptoms from their venous blockages, even after traditional care. The results from this study will contribute to medical knowledge and could pave the way for better treatment options for many people in the future.

Key takeaways

Tests a new device to clear blocked leg veins.
Aims to improve symptoms like swelling and pain.
Focuses on safety and how well the device opens veins.
Participation involves a procedure and regular check-ups for about a year.
Could help develop better treatments for venous obstruction.

Who may be eligible?

To be considered for this study, you would generally need to be 18 years or older and in a stable neurological condition, meaning no recent severe brain or nerve issues. You should also be able to walk and be experiencing ongoing symptoms from blocked veins, such as swelling or pain in your legs, which have been caused by previous blood clots. Doctors would need to confirm that your vein blockage is in a treatable area.

There are certain situations that would unfortunately mean you couldn't join the study. For example, if you have other serious health conditions that might shorten your life significantly, or make surgery very risky. Recent major surgery, a stroke within the last six months, or certain blood clotting disorders that can't be well-managed would also prevent participation. If you're pregnant or breastfeeding, or have had recent deep vein treatments or acute blood clots, you wouldn't be eligible. Also, if you have severe memory problems preventing you from understanding the study, or are already in another clinical trial that might conflict with this one, you wouldn't be able to take part.

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 18 years old or older?
Do you experience ongoing leg swelling or pain from old blood clots?
Are you generally able to walk around?
Have you not had a stroke in the last 6 months?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you meet the initial criteria and are interested, you'll first have a screening appointment. If you're suitable, you’ll be asked to sign a consent form, which means you agree to take part and understand what's involved. After this, you would have the main procedure using the Recana Thrombectomy Catheter System. You would be closely monitored from the day of the procedure until you leave the hospital. Following your procedure, you'll have several follow-up appointments over the course of a year. These appointments are scheduled at 30 days, 90 days, 180 days, and 365 days after your treatment. At these visits, doctors will check your veins using ultrasound scans, assess your overall health and well-being, ask about your quality of life, and record any medications you're taking or any new health events. The total duration of your involvement in the study, from initial screening to your last follow-up, will be around 12 to 15 months.

Potential risks and benefits

Participating in this study might offer the potential benefit of trying a new treatment that could help improve symptoms caused by your blocked veins. However, as with any medical procedure, there are potential risks, such as bleeding, infection, allergic reactions, or other complications related to the device or the procedure itself. These will be fully explained before you agree to take part. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

St. Thomas' Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'venous obstruction'?

It means your veins, often in the legs, are partly or completely blocked, which can stop blood from flowing properly and cause symptoms like swelling or pain.

What is the Recana Thrombectomy Catheter System?

It's a new medical device that doctors are testing to see if it can safely and effectively clear out blockages in veins caused by old blood clots.

How long will I be involved in the study?

From the time you join until your last follow-up visit, your involvement will last for about 12 to 15 months.

Will I have to pay to be part of this study?

No, you will not have to pay to participate in the clinical study. All study-related treatments and assessments are covered by the research.

What happens after the treatment?

You will have regular check-ups at 30, 90, 180, and 365 days after the procedure to see how you are recovering and how your veins are doing.

How to find out more

Clinical Affairs Team

clinsupport@intervene-med.com 6509957137 Official trial record

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