The Prevail Global Study is a research project to test the safety and effectiveness of the Prevail Drug-Coated Balloon (DCB) used in heart procedures. This study is focused on two groups of patients: those with in-stent restenosis (ISR) and those with de novo lesions in small vessels. In-stent restenosis means the artery has narrowed again after a stent was placed. De novo lesions are new blockages in the heart's small vessels. The study compares the Prevail DCB with existing treatments to see if it works better or has fewer side effects.
- The study lasts about 5 years and involves follow-up visits.
- Participants must be 18 years or older and willing to follow study guidelines.
- There are certain health conditions or medications that might prevent participation.
If you have stable or unstable angina (chest pain), or a mild heart attack, and you are interested in participating, you may qualify for this study. Always discuss with your doctor to see if joining is a good choice for you.