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

NACompletedINTERVENTIONAL
Enrollment

442

Participants

Timeline

Start Date

June 3, 2013

Primary Completion Date

May 17, 2018

Study Completion Date

June 22, 2021

Conditions
Critical Limb Ischemia
Interventions
DEVICE

Lutonix DCB

DEVICE

Uncoated PTA Catheter

Trial Locations (51)

3600

ZOL St. Jan, Genk

6000

Kantonsspital Luzern, Lucerne

10029

Mount Sinai School of Medicine, New York

20010

MedStar Washington Hospital Center, Washington D.C.

23507

Sentara Medical Group, Norfolk

25304

Charleston Area Medical Center Health System, Charleston

27607

NC Heart & Vascular Research, Raleigh

29425

Medical University of South Carolina, Charleston

32605

Cardiovascular Research of North Florida, LLC, Gainesville

32611

University of Florida, Gainesville

33140

Mt. Sinai Medical Center, Miami Beach

33756

Morton Plant Mease Health Care, Inc, Clearwater

33805

Radiology and Imaging Specialists of Lakeland, P.A, Lakeland

34208

Cardiovascular Solutions Institute, LLC, Bradenton

37403

University Surgical Associates, LLC, Chattanooga

37660

Wellmont Cardiology Services, Inc., Kingsport

39216

Jackson Heart Clinic, P.A., Jackson

44195

Cleveland Clinic Foundation, Cleveland

45220

Trihealth Heart Institute, Cincinnati

48149

Universitätsklinikum Münster, Innere Medizin C, Münster

49519

Metro Health-University of Michigan Health Hospital, Wyoming

50266

Central Iowa Hospital Corporation, West Des Moines

53215

Aurora St. Luke's Vascular Center, Milwaukee

59759

Klinik für Kardiologie • Klinikum Arnsberg GmbH, Arnsberg

62701

Prairie Education and Research Cooperative, Springfield

63110

Barnes Jewish Hospital, St Louis

69120

Med. Universitaet Heidelberg,Herzzentrum (Abteilung Innere Medizin III), Heidelberg

70360

CIS Clinical Research Corporation, Houma

72076

University of Tubingen, Dept. of Diagnostic and Interventional Radiology, Tübingen

78756

Austin Heart PLLC, Austin

79189

Universitaets Herzzentrum Freiburg/Bad Krozingen, Bad Krozingen

87102

New Mexico Heart Institute, LLC, Albuquerque

87509

Hospital Kempten, Immenstadt im Allgäu

96515

Medinos Kliniken des Landkriess Sonneberg GmbH, Sonneberg

97225

Providence Health & Service - Oregon, Portland

06510

Yale University-Yale New Haven Hospital, New Haven

02135

Steward St. Elizabeth Medical Center of Boston, Boston

02215

Beth Israel Deaconess Medical Center, Boston

08015

Deborah Heart & Lung Ctr, Browns Mills

07666

Holy Name Medical Center, Teaneck

43214-3907

OhioHealth Corporation, Columbus

02906

The Miriam Hospital - A Lifespan Partner, Providence

A-8036

Medical University Graz, Graz

M5G2M9

University Health Network, Toronto

04103

Universitaetsklinikum Leipzig Medical Centre, Leipzig

Unknown

Maria Cecilia Hospital, Cotignola

344-0063

Kasukabe Chuo General Hospital, Kasukabe

105-0003

The Jikei University Hospital, Minato-ku, Tokyo

536-0025

Morinomiya Hospital, Osaka

596-8522

Kishiwada Tokushukai Hospital, Osaka

153-8515

Toho University, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Bard Ltd

INDUSTRY

lead

C. R. Bard

INDUSTRY

NCT01870401 - Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries | Biotech Hunter | Biotech Hunter