RecruitingNAINTERVENTIONAL

The PERSEVERE Study

The PERSEVERE Study is a clinical trial investigating a new way to treat serious blood clots in the lungs, known as pulmonary embolism (PE). Specifically, it's comparing a device called the FlowTriever System with the usual care provided by the NHS. This study is for patients who have what's considered a 'high-risk' PE, meaning their clot is particularly serious. Researchers want to understand if the FlowTriever device offers a better outcome than current treatments. It's a randomised controlled trial, which means participants will be randomly assigned to receive either the FlowTriever treatment or standard care. The aim is to gather unbiased evidence about the safety and effectiveness of this new intervention for a life-threatening condition.

At a glance

Status

Recruiting

Phase

Sponsor

Inari Medical

Enrolment target

200

Start

16 Dec 2024

Estimated completion

01 Feb 2028

Pulmonary Embolism Pulmonary Thromboembolism

What is this study about?

The PERSEVERE Study is a research project designed to help doctors find the best treatments for a serious condition called pulmonary embolism, or PE. PE happens when a blood clot, usually from another part of the body like the leg, travels to the lungs and blocks blood flow. This can be very dangerous and even life-threatening, especially when it's a 'high-risk' PE, meaning the clot is significantly affecting the heart.

Currently, there are standard ways the NHS treats PE, which often involve medications to dissolve clots. This study is looking at a new device called the FlowTriever System. This system is designed to physically remove blood clots from the lungs using a special catheter, which is a thin tube inserted into a blood vessel. The study wants to see how well this device works compared to the standard treatments we already have.

By comparing these two approaches, the 'FlowTriever System' and 'Standard Care', researchers hope to learn if the new device can lead to better recovery, fewer problems, or improve the overall health of patients with severe lung clots. This kind of research is essential to continuously improve medical care and ensure patients receive the most effective treatments available.

Key takeaways

This study compares a new device (FlowTriever) to standard care for severe lung clots.
It's for people with 'high-risk' pulmonary embolism, meaning very serious clots.
Participation involves being randomly assigned to one of the two treatments.
The aim is to find out if the new device offers a better or safer treatment option.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and have a confirmed, severe blood clot in your lung (pulmonary embolism), specifically one that doctors classify as 'high-risk'. This means the clot is serious enough to be affecting your heart's ability to pump blood properly. You also need to be able to understand the study and agree to take part, or have a legal representative agree for you if you're unable to.

There are several reasons why someone might not be able to join the study. For example, if you've recently had a stroke or major surgery to your head or spine (within the last two weeks). You also wouldn't be eligible if you have known long-term lung clot conditions, any active or severe bleeding, a brain tumour, or other serious health problems that doctors believe would make the study unsafe for you or interfere with the results. If you are already taking part in another medical study that might affect this one, you also couldn't join.

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?
Have you recently been diagnosed with a severe lung blood clot (high-risk pulmonary embolism)?
Have you had a stroke or major brain/spine surgery in the last two weeks?
Do you have a severe bleeding problem or a known brain tumour?
Are you currently involved in another medical study?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part in the PERSEVERE Study, you will be randomly assigned to receive either treatment with the FlowTriever System or standard NHS care for your pulmonary embolism. Both treatments will be given by medical professionals. You will have regular check-ups and tests, which may include scans and blood tests, to monitor your health and recovery. The study team will guide you through all necessary appointments and what to expect. The total duration of your participation, including follow-up visits, will vary depending on your individual treatment and recovery, but the study team will provide you with a clear schedule.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new treatment that could be more effective for your severe lung clot. However, as with any medical procedure, there are potential risks associated with both the FlowTriever System and standard care, such as bleeding, infection, or other complications. The study doctors will explain all known risks to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

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

Yale University
Verified postcode
New Haven, United States· Recruiting
Orlando Health Regional Medical Center
Verified postcode
Orlando, United States· Recruiting
Sarasota Memorial Hospital
Verified postcode
Sarasota, United States· Recruiting
Emory University
Verified postcode
Atlanta, United States· Recruiting
University of Mississippi Medical Center
Verified postcode
Jackson, United States· Recruiting
Northwell Health
Verified postcode
Bay Shore, United States· Recruiting
SUNY, The University at Buffalo
Verified postcode
Buffalo, United States· Recruiting
Summa Akron
Verified postcode
Akron, United States· Recruiting
UPHS Penn Health System
Verified postcode
Philadelphia, United States· Recruiting
Allegheny General Hospital
Verified postcode
Pittsburgh, United States· Recruiting
HCA Tristar/Centennial
Verified postcode
Nashville, United States· Recruiting
HCA Medical City Heart & Spine
Verified postcode
Dallas, United States· Recruiting

Common questions

What is a 'pulmonary embolism'?

It's a serious condition where a blood clot blocks an artery in your lungs, affecting blood flow and oxygen to your body.

What is the FlowTriever System?

It's a device designed to physically remove blood clots from the lungs using a small tube inserted through a blood vessel.

What does 'standard care' mean?

It refers to the usual treatments the NHS provides for lung blood clots, often involving medications to dissolve the clots.

Will I know which treatment I'm getting?

Because it's a 'randomised' study, you will be assigned to either the FlowTriever System or standard care by chance, like flipping a coin. You might not know until after treatment is decided.

Will my regular doctor still be involved?

Yes, your regular doctors will be kept informed about your participation and will continue to work with the study team to ensure you receive the best care.

How to find out more

Tine Devolder

tine.devolder@inarimedical.com +32 476 53 88 05 Official trial record

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