Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae

NARecruitingINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

August 7, 2018

Primary Completion Date

September 30, 2025

Study Completion Date

March 31, 2030

Conditions
Arteriovenous Fistula
Interventions
DEVICE

LUTONIX 035 Drug Coated Balloon PTA Catheter

All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Trial Locations (26)

10032

RECRUITING

Columbia University Medical Center, New York

14621

TERMINATED

Rochester General Hospital, Rochester

17033

RECRUITING

Penn State Health Milton S. Hershey Medical Center, Hershey

21401

TERMINATED

MedStar Health Research Institute, Annapolis

23507

RECRUITING

Sentara Medical Group, Norfolk

35233

TERMINATED

University of Alabama at Birmingham, Birmingham

36305

TERMINATED

Flowers Hospital, Dothan

40202

RECRUITING

University of Louisville, Louisville

48109

RECRUITING

University of Michigan, Ann Arbor

52242

RECRUITING

University of Iowa Hospital and Clinics, Iowa City

55455

RECRUITING

University of Minnesota, Minneapolis

70121

RECRUITING

Ochsner Health System, New Orleans

71103

RECRUITING

Ochsner Louisiana State University Health, Shreveport

75208

RECRUITING

Dallas Vascular Center, Dallas

77004

RECRUITING

HCA Houston Healthcare, Houston

77030

RECRUITING

Houston Methodist Hospital, Houston

RECRUITING

University of Texas Health Science Center, Houston

92123

RECRUITING

Kaiser Permanente, San Diego

92868

TERMINATED

St. Joseph Hospital of Orange, Orange

06520

TERMINATED

Yale University, New Haven

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

07601

TERMINATED

Hackensack University Medical Center, Hackensack

L6R 3J7

TERMINATED

William Osler Health System/Brampton Civic Hospital, Brampton

M1P 2V5

RECRUITING

Scarborough Health Network, Scarborough Village

M5G 1Z5

RECRUITING

University Health Network, Toronto

H2X 0C1

RECRUITING

Centre hospitalier de l'Université de Montreal, Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

C. R. Bard

INDUSTRY