Active not recruitingPHASE4INTERVENTIONAL

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism

This study, called HI-PEITHO, is investigating the best way to treat blood clots in the lungs, known as pulmonary embolism (PE). Many treatments exist, but it's not clear which is most effective for certain patients. This research will compare two treatments already in use: standard blood-thinning medication, and a combination of blood thinners with a special device called the EkoSonic™ Endovascular System. This device uses ultrasound to help dissolve clots more quickly. Patients will be randomly assigned to one of these treatments and followed for 12 months with several check-ups. The main goal is to find out if one treatment is better at preventing serious problems like further clots or even death. This study aims to improve treatment for patients at higher risk.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Boston Scientific Corporation

Enrolment target

544

Start

02 Aug 2021

Estimated completion

01 Aug 2026

Pulmonary Embolism

What is this study about?

Blood clots in the lungs, called pulmonary embolism or PE, can be very serious. While there are treatments available, doctors are always looking for the best and safest ways to help patients. This study, called HI-PEITHO, is an important step in that direction. It's designed to compare two treatments that doctors already use for PE. One treatment involves giving you standard blood-thinning medication (anticoagulation), which helps stop existing clots from growing and prevents new ones.

The other treatment combines these blood thinners with a special technique using a device called the EkoSonic™ Endovascular System. This device is inserted into your blood vessels and uses ultrasound waves to help dissolve the blood clot in your lungs more quickly. By comparing these two approaches, researchers hope to understand if one is more effective at preventing serious issues like further health problems or even death, especially for patients who are at a higher risk of complications from PE.

Patients taking part in this study will be looked after carefully. You will be monitored closely while in the hospital and for 12 months afterwards with several follow-up appointments. The information gathered from this study will help doctors worldwide make better decisions about how to treat pulmonary embolism, improving care and safety for future patients.

Key takeaways

The study aims to find the best way to treat blood clots in the lungs (pulmonary embolism).
It compares standard blood thinners with blood thinners plus a special clot-dissolving device.
Participation involves being randomly assigned to one of these two treatments.
You'll have several check-ups over a 12-month period.
The goal is to improve treatment and reduce serious problems for patients with PE.

Who may be eligible?

To be able to join this study, specific health requirements must be met. Generally, you would need to be between 18 and 80 years old and have a confirmed acute pulmonary embolism (blood clot in your lung). Your clot would need to be visible on a special scan (CTPA).

Doctors would also look for signs that you might be at a higher risk of complications. This could include having a fast heart rate, low blood pressure, or breathing difficulties. They would also check for signs of strain on your heart and certain blood markers.

However, some conditions would mean you couldn't take part. This includes if your blood clot is causing immediate danger to your life and requires emergency treatment like CPR or if you need life support. You also couldn't join if you have very low blood pressure that can't be easily stabilised, or if you need to be in intensive care for other reasons. A doctor or nurse involved in the study can explain all these points clearly to 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 80 years old?
Have you been diagnosed with a blood clot in your lung (pulmonary embolism)?
Do doctors think your PE might put you at a higher risk of complications (e.g., fast heart rate, low blood pressure)?
Are you willing to attend follow-up appointments for 12 months?
Are you able to provide your informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first sign a consent form, showing you understand what's involved. You would then be randomly assigned to receive one of two treatments: either standard blood-thinning medication, or the blood-thinning medication combined with the EkoSonic™ device that helps break down clots. You would have about a 50/50 chance of getting either treatment.

During your hospital stay, you'll have various assessments, which might include blood tests and scans. After leaving the hospital, you'll have several follow-up appointments over 12 months. These check-ups will usually happen at 7 days, 30 days, 6 months, and 12 months after you started the study. These appointments help doctors monitor your progress, check your health, and see how well the treatment is working for you.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a treatment that could be more effective or lead to a quicker recovery from your blood clot. However, there are also potential risks involved with any medical treatment, and these will be fully explained to you by the study team. Both treatments in the study are currently used by doctors, but like all medical procedures, they carry some risks. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (60)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Cedars - Sinai Medical Center
Verified postcode
Los Angeles, United States
Christiana Hospital
Verified postcode
Newark, United States
Piedmont Hospital
Verified postcode
Atlanta, United States
Emory University Hospital
Verified postcode
Atlanta, United States
Augusta University
Verified postcode
Augusta, United States
Methodist Hospitals
Verified postcode
Merrillville, United States
Baptist Health East Louisville
Unverified
Lousville, United States
University of Maryland School of Medicine
Verified postcode
Baltimore, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
University of Michigan Hospitals
Verified postcode
Ann Arbor, United States
Henry Ford Hospital
Verified postcode
Detroit, United States

Common questions

What is a pulmonary embolism?

A pulmonary embolism is a serious medical condition where a blood clot blocks one of the blood vessels in your lungs, making it difficult to breathe and affecting how your heart works.

What is 'blood thinner' medication?

Blood thinner medication, also called anticoagulants, helps stop blood clots from forming or growing larger. They are a common treatment for conditions like pulmonary embolism.

What is the EkoSonic™ Endovascular System?

This is a special device that doctors can use to help break down blood clots more quickly. It uses ultrasound waves and delivers clot-dissolving medicine directly to the clot in your lung.

Will I know which treatment I'm getting?

Yes, you would know which treatment you are receiving as one involves a specific procedure with a device, while the other is medication only.

How long will I be involved in the study?

You would be followed for a full 12 months after you start the study, with several check-ups during that time.