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.

To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.

Key Inclusion Criteria:

1. Male or non-pregnant female ≥18 years of age.
2. Rutherford Clinical Category 4-5
3. Significant stenosis (≥70%)
4. A patent inflow artery
5. Target vessel(s) diameter between 2 and 4 mm
6. Target vessel(s) reconstitute(s) at or above the ankle

See clinicaltrials.gov for full details.
Heart and Vascular
Peripheral Artery Disease
Ethan Korngold MD
BARD (C.R. Bard, Bard Medical)
Ellen Muir
  • Providence St. Vincent Medical Center