What is the Purpose of this Study?

This study will compare the safety and effectiveness of an experimental device called the AGENT Paclitaxel Coated Balloon Catheter (AGENT DCB) to standard-of-care treatment in patients with untreated coronary artery disease caused by narrowing blood vessels that have not been treated before. The study focuses on patients whose doctor has determined that the narrowing of blood vessels should be treated with percutaneous coronary intervention (PCI). PCI is a minimally invasive surgical procedure and typically includes placing either a drug-eluting stent or balloon angioplasty into a narrowed blood vessel. A drug-eluting stent is a small tube that has been coated in a medication to help prevent the blood vessel from becoming narrow again. In a balloon angioplasty, doctors insert a thin tube with a tiny balloon inside the blood vessel to help open it up so that blood can flow freely again. The AGENT DCB consists of a balloon that would be used for a typical balloon angioplasty but is coated with a drug called paclitaxel that researchers believe will help keep the blood vessel from becoming narrow again. Participants will be randomly assigned to treatment with either with the AGENT DCB or the standard-of-care treatment using a drug-eluting stent and/or a standard (non-drug coated) balloon.

Eligibility

Where can I participate?