Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter

NACompletedINTERVENTIONAL
Enrollment

1,005

Participants

Timeline

Start Date

April 23, 2015

Primary Completion Date

October 27, 2017

Study Completion Date

October 21, 2019

Conditions
Peripheral Arterial DiseasePeripheral Vascular DiseasesArterial Occlusive Diseases
Interventions
DEVICE

PTA (Lutonix® 035 DCB Catheter)

"Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.~The Lutonix® DCB through the blood vessel to the narrowed area to be treated."

Trial Locations (73)

10003

Mount Sinai Beth Israel, New York

10075

The Feinstein Institute for Medical Research, New York

11355

New York Hospital-Queens, Flushing

13210

The Research Foundation for Suny, Syracuse

15212

Allegheny-Singer Research Institute, Pittsburgh

16502

Saint Vincent Consultants in Cardiovascular Diseases, Erie

17043

Pinnacle Health Cardiovascular Institute, Wormleysburg

17110

Heart Institute at Largo, Harrisburg

19010

Lankenau Institute for Medical Research, Bryn Mawr

20010

MedStar Health Research Institute, Washington D.C.

21401

MedStar Health Research Institute, Annapolis

23225

Virginia Cardiovascular Specialists, Richmond

23542

Sentara Medical Group, Virginia Beach

25304

CAMC Health Education and Research Institute, Charleston

27401

LeBauer Cardiovascular Research Foundation, Greensboro

27607

Rex Hospital, Inc, Raleigh

28054

CaroMont Heart Clinical Research, Gastonia

28562

Carolina East Health System, New Bern

29118

Vascular Access Solutions, Orangeburg

30322

Emory University, Atlanta

30342

Northside Hospital, Inc, Atlanta

31792

Vascular Interventional of Thomasville, Associates, Thomasville

32207

Jacksonville Center for Clinical Research, Jacksonville

32216

Sarah Cannon Research Institute, LLC, Jacksonville

32803

Florida Hospital, Orlando

32806

Orlando Health, Orlando

33435

Research Physicians Network Alliance, Boynton Beach

33756

Clearwater Cardiovascular & Interventional Consultants, Clearwater

34205

Bradenton Cardiology Center, Bradenton

35010

Lake Martin Laser and Vein Institute, Alexander City

38120

Stern Cardiovascular Foundation Inc., Memphis

38138

Stern Cardiovascular Foundation, Inc, Germantown

39402

Merit Health Wesley, Hattiesburg

43603

Jobst Vascular Institute, Toledo

45211

Mercy West Hospital, Cincinnati

46237

Franciscan St. Francis Health, Indianapolis

48202

Henry Ford Health System, Detroit

48236

St. John Hospital and Medical Center, Detroit

48912

Sparrow Clinical Research Institute, Lansing

49684

Munson Medical Center, Traverse City

49770

Cardiac & Vascular Research Center of Northern Michigan/McLaren Northern Michigan Hospital, Petoskey

49855

DLP Marquette General Hospital, Marquette

52242

University of Iowa Hospitals and Clinics, Iowa City

52803

Midwest Cardiovascular Research Foundation, Davenport

53211

Columbia St. Mary's, Inc., Milwaukee

53713

Wisconsin Heart-Meriter, Madison

54301

Bellin Memorial Hospital, Inc, Green Bay

61637

Peoria Radiology & Research Foundation, Peoria

62701

Prairie Education and Research Cooperative, Springfield

64804

Freeman Health System, Joplin

67502

Hutchinson Regional Medical Center - Hutchinson, Inc, Hutchinson

73104

University of Oklahoma Health Science Center, Oklahoma City

73112

Integris Baptist Medical Center, Inc, Oklahoma City

74006

Jane Phillips Memorial Medical Center, Bartlesville

75203

Methodist Health System Clinical Research Institute, Dallas

77030

Houston Methodist Research Institute, Houston

78705

Seton Heart Institute, Austin

78758

Cardiovascular Specialists of Texas, Austin

79902

El Paso Cardiology Associates, P.A., El Paso

80228

Colorado Heart and Vascular, Lakewood

85006

St. Luke's Hospital- Phoenix, Phoenix

85224

Chandler Regional Medical Center, Chandler

92093

UCSD Health System, San Diego

96819

Kaiser Foundation Hospitals, Honolulu

97225

Providence Health & Service, Portland

98004

Lake Washington Vascular, PLLC, Bellevue

06102

Hartford Hospital, Hartford

04102

Maine Medical Center, Portland

02601

Cape Cod Research Institute, Hyannis

07601

Hackensack University Medical Center, Hackensack

08035

Cardiovascular Associates of Delaware Valley, Haddon Heights

07754

Jersey Shore University Medical Center, Neptune City

02906

The Miriam Hospital - A Lifespan Partner, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

C. R. Bard

INDUSTRY

NCT02424383 - Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter | Biotech Hunter | Biotech Hunter