VITUS Post-Market Registry

This study is looking for patients who are already receiving treatment for blocked arteries in their legs using the VITUS drug-coated balloon, as decided by their doctor. The area of the artery being treated needs to be a certain size and length that matches what the balloon is designed for. Your doctor will make sure this applies to you.

However, some people might not be able to join. This includes if there's a high chance you wouldn't be able to attend all the follow-up appointments, or if you're already involved in another study that checks how your leg arteries are doing. Also, if a doctor thinks your life expectancy is less than a year, or if the artery blockage is still quite severe after an initial treatment, you wouldn't be able to take part. Of course, you also can't join if you simply don't want to.

If you take part in this registry, you won't be given any new or experimental treatment — you'll be receiving the VITUS drug-coated balloon as part of your standard medical care, just as your doctor would normally recommend. The main part of your participation involves doctors collecting information about your health and the treatment outcome. This includes data right after your procedure, then a series of follow-up checks.

These follow-up checks happen at 30 days, 6 months, 12 months, 24 months, and 36 months after your procedure. These can be done either through a phone call or during a planned hospital visit, whatever is easiest and most appropriate. The total duration of your participation in the registry would be three years.