RecruitingOBSERVATIONAL

Restrospective Analysis of MACE in Patients Treated With Drug-elluting Balloons.

This study is reviewing past information from adults (18 and over) who received a special type of heart procedure using what's called a 'drug-eluting balloon' between January 2010 and December 2025. These procedures were done to help treat conditions like narrowed arteries in the heart (coronary artery disease) or issues where arteries narrowed again after a previous treatment (restenosis). The researchers are looking at existing records to see how these patients have fared over time, specifically checking for any major heart problems they might have experienced and their general health status. This helps them understand how well these special balloons have worked in real-world settings.

At a glance

Status

Recruiting

Sponsor

Olivier F. Bertrand

Enrolment target

1,500

Start

10 Jun 2025

Estimated completion

01 Mar 2036

Coronary Arterial Disease (CAD)Restenosis, Coronary Bifurcation Coronary Disease

What is this study about?

Imagine your heart's blood vessels are like pipes, and sometimes they get clogged or narrow, making it hard for blood to flow. This is called coronary artery disease. Doctors often use a procedure called an angioplasty to open them up. In some cases, they use a special tool called a 'drug-eluting balloon' which not only opens the vessel but also releases medicine to help prevent it from narrowing again.

This study isn't a new experiment where people get different treatments. Instead, it's a 'retrospective analysis.' This means scientists are looking back at information that was already collected from patients who had this specific balloon treatment in the past. They're reviewing medical records from people treated between 2010 and 2025 at one medical centre.

The main goal is to understand how well patients did after their procedure. They are specifically checking for serious heart problems that might have happened later on and also seeing how patients are doing generally. This helps doctors learn more about the long-term effects of these drug-eluting balloons in everyday medical care.

Key takeaways

This study reviews existing medical records, not new treatments.
It focuses on patients who had a 'drug-eluting balloon' procedure for heart conditions.
Data from 2010-2025 is being analysed to see long-term outcomes.
The goal is to understand how these balloons prevent future heart problems.
No active participation is required from patients.
Findings could help improve future heart treatments.

Who may be eligible?

This study is looking at information from adults aged 18 or older who had a heart procedure with a special 'drug-eluting balloon' at the hospital between January 2010 and December 2025. It doesn't matter if you are male or female; both are included.

However, you wouldn't be included if some of your medical information after the procedure isn't complete or can't be found. Also, if other devices were used alongside the drug-eluting balloon during your procedure, your information won't be part of this particular study.

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?
Did you have a heart procedure using a 'drug-eluting balloon' between January 2010 and December 2025?
Was this procedure done at the institution conducting this study?
Is your follow-up medical information complete?
Were no other devices used with the drug-eluting balloon during your procedure?

Answer every question to see your result.

What does participation involve?

If you are eligible for this study, you won't need to do anything new. This is because the study is only looking at existing medical records that have already been collected. You won't be asked to come in for extra appointments, take new medication, or have any follow-up tests. Your name and personal details will be kept private, and researchers will only look at the important medical information related to your heart procedure and how you've been doing since. This is not a study where new treatments are given; it's purely about reviewing past data.

Potential risks and benefits

Since this study only involves reviewing existing medical records, there are no direct physical risks to you from participating. Your personal information will be kept confidential and anonymised wherever possible. The potential benefit of this study is that by looking at past patient data, doctors can better understand how drug-eluting balloons work over time and improve future heart treatments for others. As there is no active participation, there is no 'withdrawal' from the study itself, but you always have the right to request that your anonymised data not be used if you previously consented and change your mind, though typically for retrospective studies, consent for data use is obtained at the time of procedure or through general hospital policies.

Locations (1)

IUCPQ
Verified postcode
Québec, Canada· Recruiting

Common questions

What is a 'drug-eluting balloon'?

It's a special balloon used during a heart procedure to open up narrowed arteries, and it also releases medicine to help prevent the artery from narrowing again during the weeks and months after treatment.

What does 'retrospective analysis' mean?

It means the researchers are looking back at information that has already been collected from patients' medical records, rather than collecting new information by asking people to participate in new tests or treatments.

Will I need to go to the hospital or take any new medicines?

No, this study only reviews existing medical records. You won't need to visit the hospital, take any new medications, or undergo any additional tests because of this study.

How will my privacy be protected?

Your personal details will be kept private. Researchers will only look at medical information, ensuring your name and other identifying details are protected.

Why is this study being done?

It's being done to learn more about how well drug-eluting balloons have worked for patients over time, helping doctors improve future treatments for people with heart conditions.

How to find out more

Michele Jadin

michele.jadin@criucpq.ulaval.ca 418-6568711 Official trial record

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