Active not recruitingNAINTERVENTIONAL

LEADERS FREE II: BioFreedom™ Pivotal Study

This research is looking into a type of heart stent called BioFreedom™ for individuals who have heart conditions and are also at a higher risk of bleeding. When you have a stent fitted, you usually need to take blood-thinning medicines for a while. This study wants to see if the BioFreedom™ stent, along with just one month of blood-thinning medication (called dual antiplatelet therapy), is just as good and safe as a standard stent with longer medication, especially for people who might be more likely to bleed. The aim is to confirm it’s not worse than previous results from a similar study. This could be important for people who might struggle with longer courses of blood thinners, making their heart treatment safer and more suitable.

At a glance

Status

Active not recruiting

Phase

Sponsor

Biosensors Europe SA

Enrolment target

1,203

Start

14 Feb 2017

Estimated completion

01 Mar 2021

Acute Coronary Syndrome High Bleeding Risk

What is this study about?

When people have narrow or blocked arteries in their heart, a common treatment is to insert a small tube called a stent to keep the artery open. Sometimes, these stents are coated with a medicine (drug-coated stents) to help prevent the artery from narrowing again. After getting a stent, most people need to take blood-thinning medicines, usually for several months, to stop blood clots from forming on the new stent.

However, some people are at a higher risk of bleeding. This means they might have serious problems if they take blood-thinning medicines for a long time. For these individuals, doctors need to find a balance between preventing blood clots and avoiding risky bleeding.

This study, called LEADERS FREE II, is focusing on a specific type of drug-coated stent called BioFreedom™. Researchers want to see if using this stent, combined with a shorter period (just one month) of blood-thinning medication, works just as well and is still safe for people who have a high risk of bleeding, compared to other treatments. Essentially, they are comparing it to what they already know about a standard stent, hoping to offer a better option for those who are more likely to bleed.

Key takeaways

This study is for people needing a heart stent who are also at a higher risk of bleeding.
It tests a special stent (BioFreedom™) with a shorter dose of blood-thinning medicine (one month).
The goal is to see if this treatment is as good and safe as other options for these patients.
Participation is voluntary, and you can stop at any time.
The study could lead to better stent treatments for people prone to bleeding.

Who may be eligible?

This study is looking for people who need a heart stent because of problems like angina or a heart attack, and who doctors believe are at a higher risk of bleeding. If you fit this description, you would also need to be a suitable candidate for taking blood-thinning medicines for just one month.

There are several reasons why doctors might consider someone to be at a higher risk of bleeding. These include if you’re already taking blood-thinning medication for another condition, are aged 75 or over, or have a history of certain health issues like a past brain bleed, recent stroke, or previous hospitalisation for bleeding. Other factors could be certain blood conditions, severe liver disease, or if you plan to have surgery soon that would stop you from taking blood thinners for longer than a month.

However, there are some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you know you wouldn't be able to take the one month of blood-thinning medicine as prescribed. Also, if you need a type of heart procedure that requires specific non-study stents, or if you have a very serious heart issue like cardiogenic shock, you wouldn't be able to take part.

Quick self-check

Do you need a heart stent for a blocked artery?
Has your doctor said you have a higher risk of bleeding?
Are you able to take blood-thinning medication for just one month?
Are you over 18 and not pregnant or breastfeeding?
Do you not have any severe short-term illnesses or certain other health conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you choose to take part in this study, you will receive the BioFreedom™ drug-coated stent as part of your heart procedure. After your stent is fitted, you will be prescribed blood-thinning medication (dual antiplatelet therapy) which you will need to take for one month. The study will involve regular follow-up appointments and checks to monitor your health and how the stent is working. This will include keeping track of any bleeding events or other complications. The exact number of visits and the total duration of your participation will be explained in detail by the study team, but typically, these studies involve monitoring over several months to a year or more.

Potential risks and benefits

Taking part in this study could potentially offer you a new treatment option tailored for individuals with a higher risk of bleeding. This might mean you only need to take blood-thinning medication for a shorter period (one month) compared to standard care, which could reduce your risk of bleeding complications. However, like any medical procedure, having a stent fitted and taking medication carries risks, including bleeding, infection, allergic reactions, or other complications related to the procedure. The study will carefully monitor your health for any side effects. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (66)

Heart Center Research, LLC
Huntsville, United States
Tri-Lakes Research
Hot Springs, United States
Scripps Health
La Jolla, United States
University of California San Diego
La Jolla, United States
Santa Barbara Cottage Hospital
Santa Barbara, United States
MedStar Washington Hospital Center
Washington D.C., United States
University of Florida Jacksonville
Jacksonville, United States
Velella Research
Sarasota, United States
Tallahassee Research Institute, Inc.
Tallahassee, United States
North Georgia Heart Foundation
Gainesville, United States
St. Luke's Idaho Cardiology Associates
Boise, United States
Jesse Brown VA Medical Center
Chicago, United States

+54 more sites — see the official record for the full list.

Common questions

What is a heart stent?

A heart stent is a tiny mesh tube that a doctor puts into a blocked or narrowed heart artery to keep it open and improve blood flow.

Why do some people need a shorter time on blood thinners?

Some individuals are more prone to bleeding, so taking blood-thinning medication for a long time could be risky for them. A shorter course might be safer while still protecting their heart.

What does 'high bleeding risk' mean?

It means a doctor has assessed that you have a higher chance of experiencing significant bleeding due to certain health conditions, medications, or age.

Will I still get blood-thinning medication?

Yes, if you're in this study, you will receive two types of blood-thinning medicine for one month after your stent is placed.

Is this stent already approved for use?

The BioFreedom™ stent is a drug-coated stent, and this study aims to gather more information on its use specifically with a shorter duration of blood thinner in high-bleeding-risk patients.