440
Participants
Start Date
March 2, 2017
Primary Completion Date
November 18, 2019
Study Completion Date
October 25, 2023
RANGER™ Paclitaxel Coated Balloon
"A procedure that utilizes a balloon coated with paclitaxel (drug) which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries."
Paclitaxel
The RANGER™ Balloon is coated with the drug Paclitaxel.
Standard Balloon Angioplasty
"A procedure that utilizes an uncoated balloon which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries."
Auckland City Hospital, Auckland
Allgemeines Krankenhaus AKH, Vienna
Hanusch-Krankenhaus, Vienna
Middlemore Hospital, Otahuhu
Clinical Trials NZ, Hamilton
Regionaal Ziekenhuis Heilig Hart Tienen, Tienen
Ziekenhuis Oost Limburg, Genk
Medizinische Univ.-Kliniken Graz, Graz
Universitair Ziekenhuis Gent, Ghent
Mount Sinai Medical Center, New York
Staten Island University Hospital, Staten Island
Temple University, Philadelphia
Christiana Hospital, Newark
Washington Hospital Center, Washington D.C.
Ohio State University Medical Center, Columbus
West Virginia University Hospitals, Morgantown
Rex Hospital, Raleigh
Coastal Carolina Surgical Associates, Wilmington
University Medical Center-Greenville Memorial Hospital, Greenville
Wellstar Hospitals, Marietta
North Florida Regional Medical Center, Gainesville
AdventHealth Orlando, Orlando
South Florida Vascular Associates, Coconut Creek
Mount Sinai Medical Center, Miami Beach
AdventHealth Sebring, Sebring
Thomas Hospital, Fairhope
Turkey Creek Medical Center, Knoxville
King's Daughters Medical Center - Kentucky Heart Institute, Ashland
Northeast Ohio Vascular Associates, Inc., Willoughby
Bethesda North Hospital, Cincinnati
Premier Cardiovascular Institute, Dayton
Community Hospital, Munster
St. Joseph Hospital, Fort Wayne
Aspirus Heart and Vascular Institute, Wausau
United Heart and Vascular Clinic, Saint Paul
Mercy Hospital, Coon Rapids
Terrebonne General Medical Center, Houma
North Dallas Research Associates, McKinney
The Heart Hospital Baylor Plano, Plano
THR Presbyterian Plano, Plano
North Park Heart & Vascular Center, Dallas
Tyler Cardiac and Endovascular Center, Tyler
Cardiology Clinic of San Antonio, Live Oak
Texas Tech University Health Sciences Center, Lubbock
Rocky Mountain Regional VA Medical Center, Aurora
Davis Hospital and Medical Center, Layton
Kaiser Foundation Hospitals, Honolulu
St. Charles Medical Center, Bend
The Vascular Experts, Stratford
Hackensack University Medical Center, Hackensack
Jersey Shore University Medical Center, Neptune City
Peter Lougheed Centre, Calgary
Hamilton General Hospital, Hamilton
Fleurimont Hospital, Sherbrooke
Hopital Saint - Francois d'Assise, Québec
Kokura Memorial Hospital, Kitakyushu
Iwaki City Medical Center, Iwaki
Tokeidai Memorial Hospital, Sapporo
Kansai Rosai Hospital, Amagasaki
Saiseikai Yokohama-City Eastern Hospital, Yokohama
Sendai Kousei Hospital, Sendai
Kishiwada Tokushukai Hospital, Kishiwada
Kasukabe Chuo General Hospital, Kasukabe
Saiseikai Central Hospital, Minato
Kyoto Katsura Hospital, Kyoto
Morinomiya Hospital, Osaka
Osaka Saiseikai Nakatsu Hospital, Osaka
Lead Sponsor
Boston Scientific Corporation
INDUSTRY