HVP_CL0005-01 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.

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.
IDE
NCT01870401
Heart and Vascular
Peripheral Artery Disease
Ethan Korngold MD
BARD (C.R. Bard, Bard Medical)
Ellen Muir
  • Providence St. Vincent Medical Center