If you have been previously diagnosed with coronary artery disease, a narrowing (“stenosis”) of one or more blood vessels (coronary arteries) that supply blood and oxygen to the heart, then you may have been treated with a stent. A stent helps keep the artery open. When a part of the artery with a stent gets blocked or re-narrowed, it’s called in-stent restenosis (ISR). The re-narrowing can be caused by a combination of factors including more plaque build-up or scar tissue reacting to the implanted stent.
Understanding ISR Treatment Options
The re-narrowing can be treated by performing a balloon angioplasty, also known as Percutaneous Transluminal Coronary Angioplasty (PTCA). This is a minimally invasive surgical procedure used to restore blood flow through the vessel using a small inflatable balloon that is inserted and directed to your re-narrowed blood vessel using a thin tube. The balloon is expanded against the blockage to re-open the blood vessel and restore blood flow. The balloon is then deflated, and both the tube and the balloon are removed from the body.
Other treatment options for ISR are medication, stent placement, brachytherapy or coronary artery bypass graft surgery (CABG).
Another treatment option for ISR is angioplasty with a drug-coated balloon (DCB). The addition of the drug coating on the balloon could improve the performance of a standard non-drug coated balloon by decreasing repeat re-narrowing of the treated blood vessel. Many standard (non-coated) angioplasty balloons are approved by the U.S Food and Drug Administration (FDA) for the treatment of ISR, but drug-coated balloons are not. AGENT DCB is an investigational device (not approved by the U.S. FDA for commercial sale or use). It is a standard angioplasty balloon coated with a drug. The drug Paclitaxel, is commonly used in other commercially approved devices used to treat blocked blood vessels.
AGENT IDE Clinical Trial
The AGENT Investigational Device Exemption (IDE) Trial is a research study for patients with ISR whose doctors have determined treatment is needed to restore blood flow through a re-narrowed vessel. The purpose of this study is to compare the safety and effectiveness of the AGENT DCB to standard (non-drug coated) balloons.