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

Completed · Not applicable

Conditions studied: Critical Limb Ischemia

In brief

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 facts

Study ID

NCT01870401

Run by

C. R. Bard

People needed

442

Starts

2013-06-03

Expected to finish

2021-06-22

Last updated by the study team

2022-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or non-pregnant female ≥18 years of age;
• Rutherford Clinical Category 3, 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

You may not qualify if…

• Pregnant or planning on becoming pregnant;
• History of stroke within 3 months;
• History of MI, thrombolysis or angina within 30 days of enrollment;
• Planned major amputation (of either leg)
• Prior major amputation if amputation occurred less than one year prior to enrollment and if patient is not independently ambulating;
• GFR ≤ 30 ml/min per 1.73m2;
• Acute limb ischemia;
• In-stent restenosis of target lesion

Where it is running

• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Cardiovascular Solutions Institute, LLC — Bradenton, Florida, United States
• Morton Plant Mease Health Care, Inc — Clearwater, Florida, United States
• Cardiovascular Research of North Florida, LLC — Gainesville, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Radiology and Imaging Specialists of Lakeland, P.A — Lakeland, Florida, United States
• Mt. Sinai Medical Center — Miami Beach, Florida, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Central Iowa Hospital Corporation — West Des Moines, Iowa, United States
• CIS Clinical Research Corporation — Houma, Louisiana, United States
• Steward St. Elizabeth Medical Center of Boston — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Metro Health-University of Michigan Health Hospital — Wyoming, Michigan, United States
• Jackson Heart Clinic, P.A. — Jackson, Mississippi, United States
• Barnes Jewish Hospital — St Louis, Missouri, United States
• Deborah Heart & Lung Ctr — Browns Mills, New Jersey, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• New Mexico Heart Institute, LLC — Albuquerque, New Mexico, United States
• Mount Sinai School of Medicine — New York, New York, United States
• NC Heart & Vascular Research — Raleigh, North Carolina, United States
• Trihealth Heart Institute — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• OhioHealth Corporation — Columbus, Ohio, United States
• Providence Health & Service - Oregon — Portland, Oregon, United States
• Yale University-Yale New Haven Hospital — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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