300
Participants
Start Date
June 18, 2013
Primary Completion Date
September 30, 2016
Study Completion Date
March 19, 2018
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.
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).
Mount Sinai Medical Center, New York
Heritage Valley Health System, Beaver
Metro Health Hospital, Wyoming
University of Pittsburgh Medical Center, Pittsburgh
Pinnacle Health Cardiovascular Institute, INC., Wormleysburg
University of Virginia, Charlottesville
Sentara Vascular Specialist, Norfolk
CAMC Clinical Trial Center, Charleston
Rex Hospital, Raleigh
Wake Heart Research, Raleigh
Mission Hospital, Asheville
Providence Cardiology LLC, Columbia
Emory University Hospital, Atlanta
Northside Hospital, Atlanta
Coastal Vascular and Interventional, Pensacola
Cardiovascular Research of North Florida, Gainesville
Baptist Cardiac and Vascular Institute, Miami
University Surgical Associates, Chattanooga
Wellmont Holston Area Medical Center, Kingsport
Premier Surgical Associates, Knoxville
Jackson Heart Clinic, Jackson
OhioHealth Research Institute, Columbus
Jobst Vascular Institute, Toledo
North Ohio Research LTD., Elyria
Cleveland Clinic Foundation, Cleveland
St. Joseph Hospital, Fort Wayne
Cardiac & Vascular Research Center of Northern Michigan, Petoskey
Central Iowa Hospital Corporation, Des Moines
Aurora Health Care, Milwaukee
Sanford Health Vascular Associates, Sioux Falls
Advocate Health and Hospitals Corporation, Oakbrook Terrace
Oklahoma Foundation for Cardiovascular Research, Oklahoma City
Texas Health & Research Education Institution, Dallas
University of Texas Health Science Center, Houston
El Paso Cardiology Associates, El Paso
Medical Center of the Rockies, Loveland
Yuma Regional Medical Center, Yuma
Good Samaritan Hospital - Los Angeles, Los Angeles
Mission Cardiovascular Research Institute, Fremont
Providence Heart and Vascular Institute, Portland
Yale University School of Medicine, New Haven
Deborah Heart and Lung Center, Browns Mills
LKH Univ. - Klinikum Graz, Graz
Hanusch Krankenhaus Wien, Vienna
Spectranetics Corporation
INDUSTRY