Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

To join this study, you need to be at least 18 years old and able to understand and sign a consent form. If you are a woman of childbearing age, you'll need to confirm that you are not pregnant. You must have narrowed arteries in your heart, which might be causing chest pain, or show signs of heart problems during other tests. You also need to be treated with only the Vivo Isar stent for any blockages.

There are also some reasons why you might not be able to join. For example, if you are already in another medical study or if you've had a similar procedure in the last month with a different type of stent. You also can’t join if you are planning to have major surgery in the next six months, are very unwell with heart shock, or have another serious illness that might shorten your life to less than a year. If you've had a stroke in the last six months, or are under guardianship, you also won't be able to participate.

If you join this study, you will receive the Vivo Isar stent as part of your usual treatment for narrowed heart arteries. You won't be given any experimental medicines or procedures; everything used is already standard care. The main part of your participation will involve doctors collecting information about your health and how you're doing after the stent procedure. This will include follow-up checks, likely including clinic visits or phone calls, to see how you are feeling and if the stent is working well. Researchers will keep track of your progress for 12 months. You might need to have some standard tests, but these would be tests that your doctor would likely recommend anyway as part of your care.