Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II

To be considered for this study, you need to be over 18 years old and have a problem with your heart arteries that your doctor thinks needs a procedure to open them up. The artery in question should be between 2mm and 3.5mm wide and the blockage shouldn't be too long (up to 50mm). You'll also need to agree to take part by signing a consent form.

There are several reasons why someone might not be able to join. For example, if you're allergic to important medicines often used in these procedures (like aspirin or heparin), or to the medicine on the balloon or stent (sirolimus or everolimus). If you are pregnant or breastfeeding, or if your kidneys or heart aren't working well enough, you won't be able to participate. Also, if you've had a very recent heart attack (within 48 hours), or if the blockage is extremely severe, or if you've already had a stent in that specific artery, you generally won't be eligible. They also can't include you if the artery is very twisted or has a lot of hard calcium deposits.

If you decide to take part in this study, you will have a medical procedure to treat your blocked heart artery, just as you would normally, but the type of device used (a special balloon or a stent) will be chosen at random, like flipping a coin. You will then have follow-up appointments to check on your progress. These appointments will involve check-ups and possibly some tests to see how your artery is doing after the procedure. The doctors will monitor your health for a period of time to compare how well each treatment works. The total duration of your participation in the study will depend on the follow-up schedule established by the researchers.