FANTOM Post Market Clinical Trial

To join this study, you need to be at least 18 years old and have been diagnosed with coronary artery disease, meaning you have evidence of reduced blood flow to your heart. Your doctor must also think that treatment with a stent is a suitable option for you, and that you would be able to have emergency bypass surgery if needed. You also need to be able to attend all the follow-up appointments and be happy to give your written permission to take part.

There are also specific requirements for the narrowed artery itself. For example, it needs to be a new blockage, and the narrowing must be between 50% and less than 100%. The artery also needs to be a certain size, and there should be no significant complications during the initial procedure to place the stent. You mustn't be experiencing ongoing chest pain or certain heart rhythm changes at the time.

However, you won't be able to join if you have certain allergies, such as to aspirin or the dyes used in procedures. You also can't have had a major heart attack within the last 72 hours with certain blood test results still high, or if your heart's pumping ability (ejection fraction) is very low (less than 30%). Other reasons for not being able to join include severe blockages in the main heart artery that supplies blood to the left side of your heart, or if you've had a stent in the same artery in the last year.

This study is a "post-market" study, meaning the Fantom device is already in use. If you are eligible and decide to take part, you would receive the Fantom device as part of your normal medical care for coronary artery disease. Your participation primarily involves allowing the research team to collect information about your health and recovery from your medical records and during your routine follow-up appointments. This will include details about the procedure itself, how you feel afterwards, and any further treatments you might need. You would need to commit to attending all specified follow-up evaluations as requested by the study, which could involve doctor's visits and potentially some tests like angiograms (X-rays of your blood vessels). The total duration of your involvement in the study would depend on the follow-up schedule set by the researchers, which is usually for a number of years to track long-term health, but specific timings would be discussed with you by your doctor.