300
Participants
Start Date
June 18, 2013
Primary Completion Date
December 8, 2017
Study Completion Date
October 6, 2020
"Stellarex 0.035 OTW Drug-coated Angioplasty Balloon"
"The Stellarex 0.035 OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm."
EverCross™ 0.035 PTA Balloon Catheter
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, 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
Wake Heart Research, Raleigh
University of Virginia, Charlottesville
CAMC Clinical Trial Center, Charleston
Rex Hospital, Raleigh
Mission Hospital, Asheville
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 Valley Medical, 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, 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
Yale University School of Medicine, New Haven
Deborah Heart and Lung Center, Browns Mills
Medical University Graz, Graz
Hanusch Krankenhaus Wien, Vienna
Spectranetics Corporation
INDUSTRY