ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD
This study, called the ALPHA LONG Study, is looking into new sizes of a special device called the BioMatrix Alpha™ stent. These stents are used to treat Coronary Artery Disease (CAD), a condition where the blood vessels supplying the heart become narrowed. The main goal is to check if these new stent sizes are just as safe and work as well as the sizes doctors are already using. Around 85 patients in Europe will take part. Everyone in the study will be checked for 9 months after their stent procedure. The findings will help doctors offer this treatment to more people who need it, making sure they receive effective and safe care for their heart condition.
At a glance
What is this study about?
Heart artery disease (Coronary Artery Disease) happens when the blood vessels that bring blood to your heart get blocked or narrowed. This can cause chest pain or even a heart attack. One common treatment is a procedure called PCI, where doctors use a tiny tube to open up the narrowed artery. Often, a small mesh tube called a stent is placed inside the artery to keep it open.
This study, called the ALPHA LONG Study, is looking at a specific type of stent called the BioMatrix Alpha™. Doctors already use certain sizes of this stent. Now, the company has made additional sizes. This study wants to see if these new sizes are just as safe and effective as the ones already approved and widely used. This is important because having more sizes means doctors can treat a wider range of patients with different artery shapes and sizes.
The study involves about 85 patients across a few European countries. Everyone taking part will have a stent procedure and then be carefully monitored for 9 months afterwards. By comparing the results of these new stent sizes with existing medical information about the BioMatrix Alpha™ stent, researchers can make sure that these newer options provide the same good outcomes for patients.
Key takeaways
- This study is testing new sizes of a heart stent called BioMatrix Alpha™.
- It aims to make sure these new sizes are safe and work as well as existing ones.
- The study is for people with narrowed heart arteries (Coronary Artery Disease).
- Participation involves receiving the stent and 9 months of follow-up care.
- Findings could help give more people suitable treatment for their heart condition.
Who may be eligible?
To join this study, you would need to be at least 18 years old and have a specific type of heart artery blockage that can be treated with one of the study stents. You should also be well enough to have a life expectancy of more than a year and be able to take certain medications (like aspirin and another anti-clotting drug) for at least 6 months after the procedure. It's also important that you are stable enough health-wise for the procedure.
There are also reasons why you might not be able to join. For example, if you are already in another clinical trial, or if you can't take the necessary medications because of allergies. You also wouldn't be able to join if you need other types of stents put in during the same procedure or if your life expectancy is less than a year. The most important thing is that you fully understand and agree to take part.
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 at least 18 years old?
- Do you have a heart artery blockage that needs a stent?
- Are you able to take anti-clotting medications for at least 6 months?
- Do you understand and agree to all the study requirements?
- Do you expect to live for more than one year?
What does participation involve?
If you decide to take part in this study, the main part of it involves receiving a BioMatrix Alpha™ stent for your heart artery disease. After the procedure, you will be carefully watched and followed up by the study team for 9 months. This follow-up will likely involve regular check-ups and possibly some tests, similar to what you would have after any stent procedure. You will also need to take specific medications (anti-clotting drugs) for a set period and report any health changes. The total duration of your active participation, including all follow-ups, will be 9 months.
Potential risks and benefits
Locations (9)
- Klinikum BielefeldVerified postcodeBielefeld, Germany
- Krankenhaus BuchholzVerified postcodeBuchholz, Germany
- Klinikum Lippe GmbHVerified postcodeDetmold, Germany
- University Hospitals Birmingham (UHB)Verified postcodeBirmingham, United Kingdom
- Royal Blackburn HospitalVerified postcodeBlackburn, United Kingdom
- Hull University Teaching Hospitals (HUTH)Verified postcodeHull, United Kingdom
- United Lincolnshire Hospitals (ULH)Verified postcodeLincoln, United Kingdom
- The Grange University Hospital, NewportVerified postcodeNewport, United Kingdom
- Royal Albert Edward InfirmaryVerified postcodeWigan, United Kingdom
Common questions
What is a stent?
A stent is a tiny mesh tube that a doctor puts into a narrowed artery to help keep it open and improve blood flow to your heart.
What is Coronary Artery Disease?
It's a condition where the blood vessels that supply blood to your heart become narrow or blocked, which can lead to chest pain or heart attacks.
How long will the study last for me?
If you join, you will be followed up and checked by the study team for 9 months after your stent procedure.
Will I get special treatment in the study?
You will receive a BioMatrix Alpha™ stent as part of your treatment, and your health will be closely monitored by the study team.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and it won't affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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