A Prospective Multicenter Single Blind Randomized Controlled Trial Comparing the Lutonix Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries
ID Number 13-0789Principal Investigator(s)
Rami O. Tadros
Department(s) or Division(s)
The purpose of this research study is to investigate whether the treatment of narrowed leg blood vessels below the knee with the Lutonix Drug Coated Balloon Catheter is safe and beneficial. Balloon catheters are commonly used to expand narrowed blood vessels. These devices are made up of a very small balloon attached to the end of a thin tube. Lutonix has developed a balloon catheter that is very similar in shape and size to other small balloon catheters except that the balloon is coated with a drug called paclitaxel. Paclitaxel is a well-known drug that is currently used to treat a number of conditions and is also used as a coating for heart and leg vessel stents. Stents are small metal mesh-like tube devices that are permanently placed inside a blood vessel to help keep the blood vessel open. The Lutonix Drug Coated Balloon Catheter is an investigational device currently being used in ongoing human clinical studies in the United States and Europe.
Recruiting Patients: Yes