Active not recruitingNAINTERVENTIONAL

The SELUTION DeNovo Study

This study, called SELUTION DeNovo, is looking at the best way to treat coronary artery disease, which means narrowed or blocked blood vessels in your heart. We want to see if using a special balloon called SELUTION SLR, along with supportive stents if needed, is as good as, or even better than, the usual method of just using a metal tube called a stent (DES). Patients taking part will be randomly assigned to one of these two treatments. We'll be carefully checking their progress for five years to see how well each treatment works in keeping their arteries healthy and preventing future problems. The goal is to find the safest and most effective treatment for people with this condition.

At a glance

Status

Active not recruiting

Phase

Sponsor

M.A. Med Alliance S.A.

Enrolment target

3,326

Start

15 May 2021

Estimated completion

31 Oct 2030

Coronary Artery Disease

What is this study about?

Imagine the blood vessels that supply your heart with blood becoming narrow or blocked. This is what we call coronary artery disease. This study, called SELUTION DeNovo, is a research project designed to help doctors understand the best way to open up those blocked vessels and keep them open.

We're comparing two main approaches. One involves using a special kind of balloon, called a SELUTION SLR, which has a medicine on it. Sometimes, after using this balloon, a small metal tube called a stent might also be put in if needed to fully support the vessel. The other approach is the standard method, where a stent (known as a DES) is put in from the start. We want to see which of these methods leads to better long-term results for patients.

Patients who join this study will be randomly put into one of these two treatment groups. This is like flipping a coin to make sure the comparison is fair. Doctors will then provide the treatment they've been assigned. We'll be closely following participants for five years to see how they are doing, how well their arteries stay open, and if they have any health issues. This long-term follow-up is important so we can learn which treatment works best over time to improve people's heart health.

Key takeaways

This study compares two ways to treat blocked heart arteries: special balloons with optional stents, or standard stents.
It aims to find out which treatment keeps arteries healthy and open for longer.
Participants will be closely followed for up to five years.
Joining means you might receive a new treatment and contribute to medical knowledge.
You have the right to leave the study at any time.
Your doctor will discuss all details and answer any questions you have.

Who may be eligible?

To join this study, you need to be at least 18 years old (or 21 in some countries). We're looking for people who have chest pain or other signs of heart problems that suggest their heart arteries are narrowed, and their doctors believe they would benefit from treatment.

There are also a few things that would mean you couldn't join. For example, if you're pregnant or breastfeeding, if you have a serious ongoing infection like COVID-19, or if you can't take certain heart medications. We also can't include people who have very severe heart failure or who have had a recent, very serious heart attack with unstable chest pain.

Crucially, your doctor needs to identify at least one blocked heart artery that requires treatment and believes it can be successfully treated with either the special balloon and optional stent, or with a standard stent.

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 or older?
Do you have a doctor who thinks you need treatment for a blocked heart artery?
Can you take standard heart medications, including blood thinners?
Are you able to attend follow-up appointments for up to 5 years?
Are you not pregnant or breastfeeding?
Have you not had a recent, very serious heart attack or advanced heart failure?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two treatment groups: either the special SELUTION SLR balloon with a possible stent, or a standard stent. The treatment itself will be similar to what would happen during a normal procedure to open blocked arteries. After the treatment, you'll need to follow up with the study team. You'll have check-ups at 30 days, 6 months, and then yearly for up to five years. During these visits, the doctors will check your general health and how your heart is doing. The total study duration for each patient is five years.

Potential risks and benefits

Taking part in this study may offer close monitoring of your heart health. You might receive a newer treatment approach that could be as good as, or even better than, standard care. However, as with any medical procedure, there are potential risks, including those related to the procedure itself and taking study medications. There's also the chance the treatment you receive may not work as well for you. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (62)

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

Academic Teaching Hospital Feldkirch
Verified postcode
Feldkirch, Austria
University Heart Center Graz
Verified postcode
Graz, Austria
Kepler Universitätsklinikum GmbH
Verified postcode
Linz, Austria
University Hospital Brno
Verified postcode
Brno, Czechia
University Hospital Ostrava
Verified postcode
Ostrava, Czechia
SIUN sote Hospital and Healthcare center
Verified postcode
Joensuu, Finland
CH La Rochelle
Verified postcode
La Rochelle, France
Hôpital Jaques Cartier
Verified postcode
Massy, France
CHU de Nîmes
Verified postcode
Nîmes, France
Hôpital Européen Georges Pompidou
Verified postcode
Paris, France
Centre Hospitalier de Pau
Verified postcode
Pau, France
Clinique Saint Hilaire
Verified postcode
Rouen, France

Common questions

What is coronary artery disease?

It's a common heart condition where the blood vessels that supply blood to your heart become narrowed or blocked, often due to a build-up of fatty substances.

What's the difference between a balloon and a stent?

A balloon is used to push open a narrowed artery. A stent is a small mesh tube that acts like a scaffold to keep the artery open after it's been widened.

Why is the study comparing two treatments?

Doctors want to find out which treatment approach is safest and most effective in the long run for people with blocked heart arteries.

Will I know which treatment I'm getting?

Yes, once you're assigned to a group, your doctors will know which treatment plan to follow for you.

How often will I need to visit the hospital for this study?

After your initial procedure, you'll have follow-up visits at 30 days, 6 months, and then once a year for up to five years.