Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
NCT ID: NCT01870401
Last Updated: 2022-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
442 participants
INTERVENTIONAL
2013-06-03
2021-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lutonix DCB
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
PTA Catheter
Standard Uncoated PTA Catheter
Uncoated PTA Catheter
Interventions
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Lutonix DCB
Uncoated PTA Catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bard Ltd
INDUSTRY
C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick Geraghty, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Jihad Mustapha, MD
Role: PRINCIPAL_INVESTIGATOR
Metro Health Hospital
Marianne Brodmann, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University Graz, Austria
Locations
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Yale University-Yale New Haven Hospital
New Haven, Connecticut, United States
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
The Miriam Hospital - A Lifespan Partner
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University Surgical Associates, LLC
Chattanooga, Tennessee, United States
Wellmont Cardiology Services, Inc.
Kingsport, Tennessee, United States
Austin Heart PLLC
Austin, Texas, United States
Sentara Medical Group
Norfolk, Virginia, United States
Charleston Area Medical Center Health System
Charleston, West Virginia, United States
Aurora St. Luke's Vascular Center
Milwaukee, Wisconsin, United States
Medical University Graz
Graz, , Austria
ZOL St. Jan
Genk, , Belgium
University Health Network
Toronto, Ontario, Canada
Klinik für Kardiologie • Klinikum Arnsberg GmbH
Arnsberg, , Germany
Universitaets Herzzentrum Freiburg/Bad Krozingen
Bad Krozingen, , Germany
Med. Universitaet Heidelberg,Herzzentrum (Abteilung Innere Medizin III)
Heidelberg, , Germany
Hospital Kempten
Immenstadt im Allgäu, , Germany
Universitaetsklinikum Leipzig Medical Centre
Leipzig, , Germany
Universitätsklinikum Münster, Innere Medizin C
Münster, , Germany
Medinos Kliniken des Landkriess Sonneberg GmbH
Sonneberg, , Germany
University of Tubingen, Dept. of Diagnostic and Interventional Radiology
Tübingen, , Germany
Maria Cecilia Hospital
Cotignola, , Italy
Kasukabe Chuo General Hospital
Kasukabe, , Japan
The Jikei University Hospital
Minato-ku, Tokyo, , Japan
Morinomiya Hospital
Osaka, , Japan
Kishiwada Tokushukai Hospital
Osaka, , Japan
Toho University
Tokyo, , Japan
Kantonsspital Luzern
Lucerne, , Switzerland
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CL0005-01
Identifier Type: -
Identifier Source: org_study_id
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