RecruitingOBSERVATIONAL

A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)

This study is gathering information on a new type of heart stent called Vivo ISAR. This stent is used for people with coronary artery disease, where the arteries supplying the heart become narrowed. The study wants to see how safe and effective the Vivo ISAR stent is in real-world patients. They are also looking at patients who take blood-thinning medication (called DAPT) for a shorter time, usually three months or less after the stent is put in. Participants will be followed for a year to check their health and how the stent is performing. This helps doctors understand if this new stent and shorter medication plan are a good option for future patients.

At a glance

Status

Recruiting

Sponsor

Translumina Therapeutics Pvt Ltd.

Enrolment target

2,000

Start

10 Jan 2024

Estimated completion

01 Nov 2027

Cardiovascular Diseases

What is this study about?

Imagine your heart has pipes, called arteries, that supply it with blood. Sometimes these pipes get narrowed, which is called coronary artery disease. To fix this, doctors can put in a small mesh tube called a stent to keep the artery open. This study is looking at a new type of stent called Vivo ISAR. It's designed to be polymer-free, which means it doesn't have a plastic coating, and it releases a medicine called sirolimus to help prevent the artery from narrowing again.

The main goal of this study is to see how well the Vivo ISAR stent works and if it's safe for people with coronary artery disease. A key part of this study is also looking at patients who are advised by their doctor to take blood-thinning medicines, called Dual Antiplatelet Therapy (DAPT), for a shorter period – usually three months or less after the stent is put in. Normally, DAPT is taken for longer, so this study helps doctors understand if a shorter period is safe and effective with this specific stent.

This study is observational, which means doctors are simply watching and collecting information on patients who have already had the Vivo ISAR stent placed as part of their routine care. It's not a test where you receive a new treatment you wouldn't otherwise get. The doctors will gather information about your health over a year to learn more about the stent's performance in real-life situations.

Key takeaways

This study looks at a new heart stent called Vivo ISAR.
It aims to understand the stent's safety and how well it works.
It's for people taking blood thinners for 3 months or less after their stent.
Participation involves phone calls over a year to check on your health.
Your medical treatment will not change because of this study.
The information helps doctors better care for future patients.

Who may be eligible?

To be part of this study, you must be at least 18 years old and have already received only the Vivo ISAR stent during your heart procedure. You also need to be planning to take blood-thinning medication (DAPT) for three months or less after your procedure, as advised by your doctor. You'll need to be able to understand the study and agree to take part in writing.

There are some reasons why you wouldn't be able to join. For example, if you're currently in another medical study or if you've had a stroke in the last six months. Also, if you have a severe allergy to the stent materials or the blood-thinning medications, you wouldn't be eligible. Pregnant women or those with a very short life expectancy for other medical reasons cannot participate.

Quick self-check

Are you 18 years old or older?
Have you just received ONLY the Vivo ISAR stent?
Is your doctor planning for you to take blood-thinning medicines (DAPT) for 3 months or less?
Are you able to provide written consent to join?
Are you not currently part of another medical study?

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

What does participation involve?

If you are eligible and agree to take part, your medical information from before and during your stenting procedure will be collected from your health records. You won't have any extra doctor visits or procedures just for this study; everything will be part of your usual care.

After your stent procedure, the research team will contact you by phone at one month, three months, and 12 months. During these phone calls, they will ask you about the blood-thinning medications you are taking, if you've had any blood tests, if you've experienced any new health problems, and if you've had any other medical treatments since the last contact. These calls are expected to be short and straightforward.

Potential risks and benefits

Since this is an observational study, you won't be given any new treatments or procedures beyond what your doctor would normally recommend. Therefore, there are no additional medical risks from participating in the study itself. The potential benefit is that the information gathered from your experience can help doctors better understand the Vivo ISAR stent and how well a shorter course of blood-thinning medication works with it for future patients. You are free to withdraw from the study at any time without affecting your medical care.

Locations (32)

Zydus Hospitals
Ahmedabad, India· Recruiting
Fortis Hospital
Bangalore, India· Recruiting
Adesh Hospital
Bathinda, India· Recruiting
PGIMER
Chandigarh, India· Recruiting
National Heart Institute
Delhi, India· Recruiting
Fortis Escorts Heart Institute & Research Centre
Delhi, India· Recruiting
Fortis Escorts Heart Institute & Research Centre
Delhi, India· Recruiting
Medanta-The Medicity
Gurugram, India· Recruiting
Yashoda Hospitals
Hyderabad, India· Recruiting
Shalby Hospital
Jabalpur, India· Recruiting
Fortis Hospital
Kalyān, India· Recruiting
L.P.S Institute of Cardiology
Kanpur, India· Recruiting

+20 more sites — see the official record for the full list.

Common questions

What is a heart stent?

A heart stent is a small mesh tube placed in a narrowed artery to keep it open, helping blood flow to your heart.

What are blood-thinning medications (DAPT)?

These are medicines that help prevent blood clots. After a stent, they are often used to stop clots forming on the stent.

Will my doctor change my treatment if I join the study?

No, this study does not change your treatment plan. You will receive the same care your doctor recommends, whether you join or not.

How often will I be contacted for the study?

You'll have three phone calls from the study team: at 1 month, 3 months, and 12 months after your stent procedure.

Can I leave the study at any time?

Yes, you can decide to stop participating in the study at any point without it affecting your medical care.

How to find out more

Diptendu Chatterjee

diptenduchatterjee@translumina.in 9339948873 Official trial record

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