RecruitingNAINTERVENTIONAL

A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters

This study is looking at how effectively and safely a medical device, the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter, works. This device is used during surgery to remove blood clots (emboli or thrombi) from blood vessels. Doctors want to check its performance, identify any new risks, and make sure the benefits of using it continue to outweigh any potential downsides for patients. This is a follow-up study after the device has already been approved for use, gathering more real-world information.

At a glance

Status

Recruiting

Phase

Sponsor

LeMaitre Vascular

Enrolment target

112

Start

11 Jan 2023

Estimated completion

01 Jun 2027

Thrombus Embolus Occlusion; Vessel

What is this study about?

Imagine you have a blocked blood vessel, perhaps due to a blood clot. Doctors often need to remove these clots to help blood flow properly again. This study is all about a special tool called the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter, which is designed to do just that – safely remove blood clots from your arteries.

This isn't a study testing a brand new device from scratch. Instead, it's a 'post-market' study. This means the device is already approved and being used by doctors. The company that makes it wants to gather more information about how it performs in everyday medical practice and confirm that it continues to be safe and effective for patients across different hospitals.

They plan to enrol about 112 patients from different medical centres, likely in several countries. Each patient will be involved for about a month. The overall study will run for just over four and a half years, from start to finish, to collect all the necessary information.

Key takeaways

The study assesses an existing medical device for removing blood clots.
It aims to confirm the device's performance and safety in real-world use.
Participation involves undergoing planned surgery with this device and a one-month follow-up.
It helps gather important information for patient safety and better healthcare.
You won't receive new treatments specifically for the study.

Who may be eligible?

You might be able to take part in this study if you are 18 years old or older, male or female, and are scheduled to have surgery to remove a blood clot from a blood vessel. During this surgery, one of the LeMaitre® Embolectomy Catheters must be used. You also need to have been diagnosed with a blood clot, and if you would normally have had clot-dissolving medicine, it either didn't work for you or wasn't an option for medical reasons.

However, there are reasons you might not be able to join. If a doctor feels another health condition you have could make it hard to get clear results from the study, or if you're unable to read or write, you wouldn't be eligible. Pregnant or breastfeeding women, and people with weakened immune systems, also cannot 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?
Are you scheduled for surgery to remove a blood clot?
Will a TufTex Embolectomy Catheter be used in your surgery?
Do you have a clear diagnosis of a blood clot?
Are you NOT pregnant or breastfeeding?
Are you able to provide your consent to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement will be quite straightforward. You'll be undergoing surgery to remove a blood clot, and the study is simply observing how the TufTex Embolectomy Catheter performs during that procedure. There won't be any extra appointments or special medications specifically for the study. After your surgery, doctors will follow your progress for about a month to check on how you're doing. The total amount of time you would be actively involved in the study is just this one month.

Potential risks and benefits

The main benefit of taking part is that the TufTex catheter will be used as part of your necessary surgery to remove a blood clot. This study helps doctors confirm its safety and effectiveness, improving care for future patients. As with any medical procedure, there are potential risks associated with surgery itself, but this study doesn't introduce new or different risks beyond your planned treatment. You will be able to withdraw from the study at any time without affecting your medical care.

Locations (3)

Andrej Udelnow
Verified postcode
Brandenburg, Germany· Recruiting
University Hospital Carl Gustav Carus TU Dresden
Verified postcode
Dresden, Germany· Not yet recruiting
Ospedale Regionale di Lugano - sede Civico
Verified postcode
Lugano, Switzerland· Recruiting

Common questions

What is an embolectomy catheter?

It's a special medical tube used by doctors during surgery to remove blood clots from inside your blood vessels.

Is this a new treatment?

No, this device is already approved and used by doctors. This study is collecting more information about its performance in real-world situations.

How long will I be in the study if I participate?

Your direct participation in the study, involving follow-up after your surgery, will last for about one month.

Do I have to do anything extra for the study?

No, you won't have any extra appointments or special treatments just for this study. It observes your standard surgical care.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect the medical care you receive.

How to find out more

Andrew Hodgkinson

ahodgkinson@lemaitre.com 781-425-1664 Official trial record

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