Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

PHASE3CompletedINTERVENTIONAL
Enrollment

285

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

September 30, 2016

Study Completion Date

June 30, 2018

Conditions
Arteriovenous Fistula
Interventions
COMBINATION_PRODUCT

Lutonix DCB

DEVICE

Standard Balloon Angioplasty Catheter

PROCEDURE

Percutaneous Transluminal Angiography

"Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."

Trial Locations (23)

19104

Trustees of the University of Pennsylvania, Philadelphia

19713

Nephrology Associates, P.A., Newark

22908

University of Virginia, Charlottesville

27610

Capital Nephrology Associates, P.A., Raleigh

29303

Spartanburg Regional Health Services District, Inc., Spartanburg

29425

Medical University of South Carolina, Charleston

35233

The Board of Trustees of The University of Alabama for the University of Alabama at Birmingham, Birmingham

38115

University Vascular Access, Memphis

48507

Michigan Vascular Center, Flint

53715

Board of Regents of the University of Wisconsin System, Madison

55112

Minnesota Vascular Surgery Center, New Brighton

60559

MakrisMD, LLC, d/b/a Chicago Access Care, Westmont

60612

Rush University, Chicago

61603

RenalCare Associates, S.C. d/b/a Illinois Kidney Disease & Hypertension Center, Peoria

74104

Oklahoma Life Access, PLLC, Tulsa

76104

Tarrant Vascular Clinic, Fort Worth

78215

San Antonio Kidney Disease Center Physicians Group, PLLC, San Antonio

85012

Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC, Phoenix

85284

Southwest Clinical Research Institute, LLC, Tempe

95825

Capital Nephrology Medical Group, Sacramento

02114

Massachusetts General Physicians Organizations, Inc., Boston

01107

Renal and Transplant Associates of New England, PC, Springfield

02906

Providence Interventional Associates, LLC, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

C. R. Bard

INDUSTRY

NCT02440022 - Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae | Biotech Hunter | Biotech Hunter