Active not recruitingNAINTERVENTIONAL

IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact

This research looks at two main ways doctors guide a procedure to open blocked heart arteries (stenting). One way uses standard X-ray images, while the other uses a special ultrasound camera, called IVUS, to get a closer look inside the artery. The study wants to find out if using this ultrasound guidance leads to better long-term results for patients with tricky or complex blockages in their heart arteries. Researchers also want to check if this more detailed approach is cost-effective. They believe that better guidance during the procedure might reduce future problems and help patients stay healthier. This study will involve many people across different countries.

At a glance

Status

Active not recruiting

Phase

Sponsor

Medstar Health Research Institute

Enrolment target

3,100

Start

14 Oct 2020

Estimated completion

01 Sep 2027

Atherosclerosis

What is this study about?

When your heart arteries become narrowed or blocked, doctors sometimes recommend a procedure called an angioplasty, often involving placing a small tube called a stent to keep the artery open. This study is looking at how doctors guide placing these stents, especially in what they call 'complex' blockages – those that are particularly tricky to treat.

Currently, doctors mainly use X-ray images (angiography) to guide the stent. However, there's another method called Intravascular Ultrasound (IVUS). Think of IVUS like a tiny camera with sound waves that goes inside your artery, giving the doctor a super-clear picture from the inside. This allows them to choose the right size stent, place it perfectly, and make sure it’s fully open afterwards. Previous studies suggest that using this detailed IVUS guidance might lead to fewer problems later on, because doctors can see exactly what they're doing and achieve a better result.

This study wants to compare these two methods directly: some patients will have their stent procedure guided by standard X-rays, and others by the more detailed IVUS. The main goal is to see if IVUS guidance truly helps people with complex blockages avoid future heart problems, such as needing another procedure. They also want to understand if the extra detail from IVUS is a good investment, meaning it helps patients without being too expensive overall.

Key takeaways

This study compares two ways to guide heart stent procedures: X-ray or special ultrasound (IVUS).
It focuses on patients with complex blockages in their heart arteries.
The goal is to see if IVUS guidance improves long-term results and is good value.
Participation involves being randomly assigned to one guidance method during your stent procedure.
Your health will be followed for two years after the procedure.
You can discuss potential benefits and risks with your doctor before deciding to join.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. You would be having a stent procedure for a blocked heart artery, specifically for a blockage that your doctor considers 'high risk' or 'complex'. This could mean you have a completely blocked artery that's been there for a while, an artery that has narrowed again after a previous stent, a lot of calcium in your artery, a very long blockage, or a blockage at a branching point in your artery.

You might be experiencing symptoms like stable chest pain, new chest pain, or have had a recent mild heart attack (not a severe one). The stent procedure could be for one or more blocked arteries.

However, you wouldn't be able to join if you've had a severe heart attack (STEMI) or cardiogenic shock, or if you received clot-busting medication within 24 hours of your procedure. Other reasons you couldn't join include if you're already scheduled for another heart procedure on the same artery, if you've had a specific type of stent problem called 'stent thrombosis', or if your doctor uses another imaging method called OCT during your current procedure.

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 having a stent procedure for a complex heart blockage?
Have you *not* had a severe heart attack recently (STEMI) or cardiogenic shock?
Have you *not* had specific clot-busting medicine within the last 24 hours?
Is your doctor *not* using another imaging method called OCT during your stenting?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups: either your stent procedure will be guided by standard X-ray images, or it will be guided by the special IVUS ultrasound method. You won’t get to choose which group you’re in. Both methods use medical devices like specific types of stents which are detailed in the study information.

After your stent procedure, doctors will follow your health for a period of two years. This will involve regular check-ups and assessments, similar to the follow-up you would normally have after a stent procedure. The study itself is quite large, involving many hospitals in the UK, Europe, and North America, and will run for about 4.5 years in total, with patients being enrolled over approximately 2.5 years.

Potential risks and benefits

Participating in any clinical study has potential benefits and risks. A potential benefit of this study is that if you are in the IVUS-guided group, you might receive a more precisely placed stent, which the researchers hope could lead to fewer problems later on. Regardless of your group, you'll receive careful monitoring of your heart condition. As with any medical procedure, there are risks associated with heart stenting itself, and the study might involve some additional tests or visits. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (61)

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

Northwest Medical Center
Verified postcode
Tucson, United States
Central Arkansas Veterans Healthcare System
Verified postcode
Little Rock, United States
University of California San Deigo
Verified postcode
La Jolla, United States
San Francisco VA Health Care System
Verified postcode
San Francisco, United States
San Antonio Regional Hospital
Verified postcode
Upland, United States
Medstar Washington Hospital Center
Verified postcode
Washington D.C., United States
Manatee Memorial Hospital
Verified postcode
Bradenton, United States
AdventHealth Orlando
Verified postcode
Orlando, United States
Ascension Sacred Heart
Verified postcode
Pensacola, United States
AdventHealth Sebring
Verified postcode
Sebring, United States
Tampa Cardiovascular/St. Joseph's Hospital
Verified postcode
Tampa, United States
Emory
Verified postcode
Atlanta, United States

Common questions

What is 'atherosclerosis'?

Atherosclerosis is when your arteries, which carry blood around your body, become narrowed and hardened due to a build-up of fatty substances. This can affect blood flow to your heart.

What is a 'stent'?

A stent is a tiny mesh tube that doctors place inside a narrowed artery to prop it open and keep the blood flowing freely.

What does 'complex lesion' mean?

A 'complex lesion' simply means a heart blockage that is particularly tricky or challenging for doctors to treat, such as a very long blockage or one that's hardened with calcium.

Will I know which treatment group I'm in?

Yes, you will know if your procedure was guided by standard X-rays or by the IVUS ultrasound, as the study is 'single-blind' meaning you are aware, but the researchers measuring outcomes may not be.

How long will I be followed up?

If you participate, your health will be monitored for two years after your stent procedure.