Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

Trial Purpose and Description

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.

Ages: 18 years and older

Gender: Both

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or planning on becoming pregnant;
  • History of stroke within 3 months;
  • History of MI, thrombolysis or angina within 30 days of enrollment;
  • Prior or planned major amputation;
  • GFR ≤ 30 ml/min per 1.73m2;
  • Acute limb ischemia;
  • In-stent restenosis of target lesion


Start Date: 09/03/2013

End Date: 02/28/2017

Last Updated: 02/22/2018

Study HIC#: 1305012053

Get Involved

For more information about this study, contact:
Juan Carmona

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email or call 1-877-978-8348.

Trial Image


Sophia Elissa Altin

Principal Investigator