Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis

NACompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

February 13, 2017

Study Completion Date

March 31, 2019

Conditions
Femoral Artery StenosisFemoral Artery OcclusionRestenosis
Interventions
DEVICE

Lutonix DCB

DEVICE

Standard Uncoated Balloon Angioplasty Catheter

PTA Catheter

Trial Locations (20)

20010

MedStar Health Research Institute, Washington D.C.

23219

Virginia Commonwealth University, Richmond

27607

Rex Hospital, Inc., Raleigh

33140

Mount Sinai Medical Center, Miami

33805

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

36532

Cardiology Associates, Fairhope

37660

Wellmont Cardiology Services, Inc., Kingsport

39216

Jackson Heart Clinic, P.A., Jackson

39401

Hattiesburg Clinic, PA, Hattiesburg

45220

TriHealth, Inc., Cincinnati

48073

William Beaumont Hospital Research Institute, Royal Oak

49519

Metropolitan Hospital d/b/a Metro Health Hospital, Wyoming

53215

Aurora Medical Group, Milwaukee

55441

Minneapolis Radiology and Vascular Research Foundation, Plymouth

60208

Northwestern University, Evanston

64116

Kansas City Vascular Foundation, North Kansas City

77555

University of Texas Medical Branch, Galveston

06510

Yale University, New Haven

08822

Hunterdon Cardiovascular Associates, Flemington

02906

The Miriam Hospital - A Lifespan Partner, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

C. R. Bard

INDUSTRY

NCT02063672 - Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis | Biotech Hunter | Biotech Hunter