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Principal Investigator: Peter Soukas, MD
Sponsored by: BARD/Lutonix
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
Patients with disabling claudication below the knee
- Patients will receive the Lutonix Drug Eluting Balloon
- Standard blood tests
- Duplex Ultrasounds at clinic visits
- Clinic visits at 1 month, 12 month, 24 month and 36 moth
- Phone call follow up on Year 4 and Year 5
- Participation in this study will be 5 years
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.
The Miriam Hospital
Lori-Ann DeSimone, RN