Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

NACompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 18, 2013

Primary Completion Date

September 30, 2016

Study Completion Date

March 19, 2018

Conditions
Peripheral Arterial Disease
Interventions
DEVICE

Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.

DEVICE

EverCross Percutaneous Transluminal Balloon Catheter

The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).

Trial Locations (44)

10029

Mount Sinai Medical Center, New York

15009

Heritage Valley Health System, Beaver

15146

Metro Health Hospital, Wyoming

15232

University of Pittsburgh Medical Center, Pittsburgh

17043

Pinnacle Health Cardiovascular Institute, INC., Wormleysburg

22908

University of Virginia, Charlottesville

23507

Sentara Vascular Specialist, Norfolk

25304

CAMC Clinical Trial Center, Charleston

27607

Rex Hospital, Raleigh

Wake Heart Research, Raleigh

28801

Mission Hospital, Asheville

29204

Providence Cardiology LLC, Columbia

30322

Emory University Hospital, Atlanta

30342

Northside Hospital, Atlanta

32504

Coastal Vascular and Interventional, Pensacola

32605

Cardiovascular Research of North Florida, Gainesville

33176

Baptist Cardiac and Vascular Institute, Miami

37403

University Surgical Associates, Chattanooga

37660

Wellmont Holston Area Medical Center, Kingsport

37909

Premier Surgical Associates, Knoxville

39216

Jackson Heart Clinic, Jackson

43214

OhioHealth Research Institute, Columbus

43606

Jobst Vascular Institute, Toledo

44035

North Ohio Research LTD., Elyria

44195

Cleveland Clinic Foundation, Cleveland

46802

St. Joseph Hospital, Fort Wayne

49770

Cardiac & Vascular Research Center of Northern Michigan, Petoskey

50309

Central Iowa Hospital Corporation, Des Moines

53215

Aurora Health Care, Milwaukee

57117

Sanford Health Vascular Associates, Sioux Falls

60181

Advocate Health and Hospitals Corporation, Oakbrook Terrace

73120

Oklahoma Foundation for Cardiovascular Research, Oklahoma City

75231

Texas Health & Research Education Institution, Dallas

77030

University of Texas Health Science Center, Houston

79902

El Paso Cardiology Associates, El Paso

80538

Medical Center of the Rockies, Loveland

85364

Yuma Regional Medical Center, Yuma

90017

Good Samaritan Hospital - Los Angeles, Los Angeles

94538

Mission Cardiovascular Research Institute, Fremont

97225

Providence Heart and Vascular Institute, Portland

06510

Yale University School of Medicine, New Haven

08015

Deborah Heart and Lung Center, Browns Mills

Unknown

LKH Univ. - Klinikum Graz, Graz

Hanusch Krankenhaus Wien, Vienna

All Listed Sponsors
lead

Spectranetics Corporation

INDUSTRY

NCT01858428 - Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon | Biotech Hunter | Biotech Hunter