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



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:June 3, 2013
End Date:June 2020

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A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon Versus Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries(Lutonix BTK Trial)

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.


Inclusion Criteria:

- 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

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;

- 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
We found this trial at
35
sites
5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
Principal Investigator: Jihad Mustapha, MD
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Marc Schermerhorn, MD
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Patrick Antoun, MD
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
Principal Investigator: Samuel Steerman, MD
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Norfolk, VA
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Albuquerque, New Mexico 87102
Principal Investigator: Esteban Henao, MD
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Austin, Texas 78756
Principal Investigator: Roger Gammon, MD
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736 Cambridge Street
Boston, Massachusetts 02135
Principal Investigator: Lawrence Garcia, MD
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Bradenton, Florida 34208
Principal Investigator: Gino Sedillo, MD
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Browns Mills, New Jersey 08015
Principal Investigator: Vincent Varghese, MD
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575 Canterbury Road
Camperdown, 2194
Principal Investigator: Steven Dubenec, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Marcelo Guimaraes, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, West Virginia 25304
Principal Investigator: Aravinda Nanjundappa, MD
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Chattanooga, Tennessee 37403
Principal Investigator: Mark Fugate, MD
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Cincinnati, Ohio 45220
Principal Investigator: Patrick Muck, MD
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Clearwater, Florida 33756
Principal Investigator: Parag Patel, MD
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Sean Lyden, MD
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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180 East Broad Street
Columbus, Ohio 43214
Principal Investigator: Gary Ansel, MD
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Gainesville, Florida
Principal Investigator: Arthur Lee, MD
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Houma, Louisiana 70360
Principal Investigator: Craig Walker, MD
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Jackson, Mississippi 39216
Principal Investigator: J. Gray Bennett, MD
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Kingsport, Tennessee 37660
Principal Investigator: Christopher Metzger, MD
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Lakeland, Florida 33805
Principal Investigator: Fakhir Elmasri, MD
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Miami Beach, Florida 33140
Principal Investigator: Robert Beasley, MD
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Milwaukee, Wisconsin 53215
Principal Investigator: Mark Mewissen, MD
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New Haven, Connecticut 06510
Principal Investigator: Elissa Altin, MD
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New York, New York 10029
Principal Investigator: Rami Tadros, MD
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Ocala, Florida 34471
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Portland, Oregon 97225
Principal Investigator: Ethan Korngold, MD
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Providence, Rhode Island 02906
Principal Investigator: Peter Soukas, MD
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Raleigh, North Carolina 27610
Principal Investigator: George Adams, MD
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Saint Louis, Missouri 63110
Principal Investigator: Patrick Geraghty, MD
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Springfield, Illinois 62701
Principal Investigator: Jeffrey Goldstein, MD
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Teaneck, New Jersey 07666
Principal Investigator: John Rundback, MD
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Washington, District of Columbia 20010
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West Des Moines, Iowa 50266
Principal Investigator: Eric Scott, MD
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