Active not recruitingOBSERVATIONAL

Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients

This study, called NAGOMI COMPLEX PMCF, is designed to learn more about a new heart stent called Ultimaster Nagomi™. This stent releases a medication (sirolimus) to help keep arteries open. We are focusing on patients with 'complex' heart problems, meaning their artery blockages are more complicated. The study aims to see how well this new stent works over time, particularly in preventing serious problems such as heart attacks, heart-related deaths, or needing to have the procedure done again on the same treated area within one year. We'll also look at how it affects patients' quality of life.

At a glance

Status

Active not recruiting

Sponsor

Terumo Europe N.V.

Enrolment target

3,000

Start

25 Apr 2023

Estimated completion

29 Apr 2027

Cardiovascular Disease Coronary Artery Occlusion Ischemic Heart Disease

What is this study about?

This study is gathering real-world information about a new type of heart stent called Ultimaster Nagomi™. Stents are tiny mesh tubes that doctors place in a narrowed or blocked heart artery to help keep it open and improve blood flow. This particular stent is special because it releases a drug called sirolimus, which helps prevent the artery from narrowing again.

We're focusing on patients who have 'complex' coronary artery disease. This means their artery blockages might be more difficult to treat, for example, if they have blockages in many blood vessels, very long blockages, or blockages in tricky areas like where an artery splits. The main goal is to find out how safe and effective the Ultimaster Nagomi™ stent is for these complex cases in the year after it's been put in. We want to see if it reduces serious issues like heart attacks, heart-related deaths, or needing to have the procedure done again on the same treated area.

This is an 'observational' study, which means doctors will treat patients as they normally would using the Ultimaster Nagomi™ stent, and then we'll carefully observe their health outcomes. We'll also ask patients about their quality of life and how their chest pain (angina) is after the procedure. This information helps us understand the full picture of how well this new stent performs in everyday medical practice for people with challenging heart conditions.

Key takeaways

The study explores a new drug-eluting heart stent (Ultimaster Nagomi™) for complex heart conditions.
It aims to understand how well the stent prevents heart attacks, re-procedures, and death over one year.
Patients are treated as normal; the study observes their outcomes.
Participation involves routine follow-up appointments for two years.
It helps doctors understand how the stent works for challenging blockages.
Your quality of life and chest pain will also be monitored.

Who may be eligible?

To be considered for this study, you must be at least 18 years old and have heart disease that your doctor believes would benefit from a procedure called a PCI (percutaneous coronary intervention) using the Ultimaster Nagomi™ stent. Your medical team, and sometimes a bigger group of heart specialists, should agree that this procedure is the right step for you.

Crucially, your heart problem must fit into what we define as 'complex PCI'. This can mean a few things, such as needing stents in more than one heart artery, receiving three or more stents in total, having blockages in difficult-to-treat areas (like where a blood vessel branches), or having very long blockages. It also includes cases where an artery is completely blocked for a long time, or if you've had a stent before that has narrowed again. Your doctor will be able to tell if your specific situation matches these complex criteria.

There are also reasons why you wouldn't be able to join. For example, if you have allergies to the materials in the stent or the medications used, or if you're pregnant or breastfeeding. Also, if you have another serious illness that means you're not expected to live for at least another year, or if you need surgery soon that would stop you from taking important blood-thinning medicines, you wouldn't be eligible.

Quick self-check

I am 18 years old or older.
My doctor says I need a stent procedure (PCI) for heart disease.
My heart condition involves a "complex" blockage, as described by my doctor.
I am not pregnant or breastfeeding, and I don't have severe allergies to the stent materials or medications.
I am expected to live for at least another year.
I wouldn't need to stop important blood-thinning medication soon after the procedure.

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

What does participation involve?

If you decide to take part, the first step is to read and sign a consent form, which explains everything about the study. You will then receive the Ultimaster Nagomi™ stent as part of your standard heart treatment, chosen by your doctor. The medical team will follow their usual procedures for placing the stent and managing your care afterward, including prescribing necessary medications like blood thinners.

After your stent procedure, you will have follow-up appointments over a period of two years. During these visits, the study team will gather information about your health, any symptoms you have, and how you are feeling generally. You might be asked to fill out questionnaires about your quality of life and any chest pain you experience. For some parts of the study, details from your medical records and scans will also be collected. The total duration of your participation in the study will be two years.

Potential risks and benefits

Participating in this study means you will receive the Ultimaster Nagomi™ stent, which is already approved for use, as part of your standard medical care. The potential benefit is that your doctors will be using a stent designed to improve blood flow to your heart, and the study will help us understand more about how well it works for complex cases. As with any medical procedure, there are potential risks associated with placing a heart stent, such as bleeding, infection, or complications from the procedure itself. Your medical team will discuss these with you in detail. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (52)

Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria
Imelda Hospital
Bonheiden, Belgium
C.H.U. Charleroi
Charleroi, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Hopital de Jolimont
La Louvière, Belgium
UZ Leuven
Leuven, Belgium
CHR Citadelle
Liège, Belgium
Clinique Saint-Luc Bouge
Namur, Belgium
CHU UCL Mont Godinne Namur
Yvoir, Belgium
East Tallinn Central Hospital
Tallinn, Estonia
CHU Jean Minjoz
Besançon, France
Hôpital Louis Pradel
Bron, France

+40 more sites — see the official record for the full list.

Common questions

What is Ultimaster Nagomi™?

It's a special type of heart stent that releases a drug (sirolimus) to help keep your heart arteries open after they've been cleared.

What does 'complex PCI' mean?

It refers to heart artery blockages that are more complicated to treat, like those in multiple arteries, very long blockages, or those in tricky places.

Will I get a different treatment if I join the study?

No, you'll receive the Ultimaster Nagomi™ stent as part of your normal heart treatment, decided by your doctor. The study just observes how it works.

How long will I be in the study?

If you join, you will be followed for two years after your stent procedure.

Is this stent already approved for use?

Yes, the Ultimaster Nagomi™ stent is an approved medical device. This study aims to gather more information about its performance in complex patient cases.