Principal Investigator: Peter Soukas, MDSponsored by: BARD/LutonixA 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 Eligibility:• Patients with disabling claudication below the kneeParticipation includes:
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.
The purpose of this research study is to investigate if the treatment of narrowed leg blood vessels below the knee with the Lutonix Drug Coated Balloon Catheter is safe and beneficial.
Patients will be “randomized”, so that some are treated with the Lutonix device and others are treated with a balloon catheter with no drug.
Contact Information:Cardiovascular ResearchThe Miriam HospitalLori-Ann DeSimone, RN401-793-4105