Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/23/2018
Start Date:June 2013
End Date:July 2020

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Trial Summary
Trial Overview
Inclusion Criteria

ILLUMENATE Pivotal: ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon

This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated
percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with
peripheral arterial disease.

The ILLUMENATE Pivotal study is a prospective, randomized, multi-center, single-blind study
which will include up to 360 subjects in approximately forty-five (45) sites across the
United States to evaluate the CVI Paclitaxel-coated PTA Catheter compared to the bare
percutaneous transluminal angioplasty balloon catheter (bare balloon catheter) for the
treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for
in-stent) SFA and/or popliteal arteries.

Inclusion Criteria:

- Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral
Artery (SFA) or popliteal artery.

Exclusion Criteria:

- Known intolerance to study medications, paclitaxel or contrast agents that in the
opinion of the investigator cannot be adequately pre-treated
We found this trial at
43
sites
University of Pittsburgh Medical Center
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Baptist Cardiac and Vascular Institute
8900 North Kendall Drive
Miami, Florida 33176
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Miami, FL
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Mount Sinai Hospital
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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Mission Hospital, Inc
Asheville, North Carolina 28801
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Asheville, NC
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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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Northside Hospital
1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Atlanta, GA
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Heritage Valley Health System
Beaver, Pennsylvania 15009
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Beaver, PA
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Deborah Heart and Lung Center
Browns Mills, New Jersey 08015
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Browns Mills, NJ
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CAMC Clinical Trial Center
Charleston, West Virginia 25304
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Charleston, WV
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University of Virginia
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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University Surgical Associates, LLC
Chattanooga, Tennessee 37403
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Chattanooga, TN
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Cleveland Clinic Foundation
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Providence Cardiology LLC
Columbia, South Carolina 29204
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Columbia, SC
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OhioHealth Research Institute
Columbus, Ohio 43214
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Columbus, OH
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Texas Health & Research Education Institution
Dallas, Texas 75231
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Dallas, TX
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Central Iowa Hospital Corporation
Des Moines, Iowa 50309
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Des Moines, IA
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El Paso Cardiology Associates
El Paso, Texas 79902
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El Paso, TX
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North Ohio Research, Ltd.
Elyria, Ohio 44035
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Elyria, OH
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St. Joseph Hospital
Fort Wayne, Indiana 46802
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Fort Wayne, IN
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Mission Cardiovascular Research Institute
Fremont, California
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Fremont, CA
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Cardiovascular Research of North Florida
Gainesville, Florida
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Gainesville, FL
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LKH Univ. - Klinikum Graz
Graz, 8036
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Graz,
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University of Texas Health Science Center
Houston, Texas 77030
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Houston, TX
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Jackson Heart Clinic
Jackson, Mississippi 39216
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Jackson, MS
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Wellmont Holston Area Medical Center
Kingsport, Tennessee 37660
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Kingsport, TN
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Premier Surgical Associates
Knoxville, Tennessee 37909
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Knoxville, TN
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Good Samaritan Hospital Los Angeles
Los Angeles, California 90017
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Los Angeles, CA
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Medical Center of the Rockies
Loveland, Colorado 80538
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Loveland, CO
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Aurora Health Care
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Yale University School of Medicine
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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Sentara Vascular Specialist
Norfolk, Virginia 23507
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Norfolk, VA
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Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois 60181
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Oakbrook Terrace, IL
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Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma 73210
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Oklahoma City, OK
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Coastal Vascular & Interventional, PLLC.
Pensacola, Florida 32204
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Pensacola, FL
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Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan
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Petoskey, MI
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Providence Heart & Vascular Institute
Portland, Oregon 97220
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Portland, OR
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Rex Hospital, Inc
Raleigh, North Carolina 27607
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Raleigh, NC
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Wake Heart Research
Raleigh, North Carolina 27610
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Raleigh, NC
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Sanford Health Vascular Associates
Sioux Falls, South Dakota 57117
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Sioux Falls, SD
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Jobst Vascular Institute
Toledo, Ohio 43606
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Toledo, OH
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Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania 17043
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Wormleysburg, PA
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Metro Health Hospital
5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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Wyoming, MI
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Yuma Regional Medical Center
Yuma, Arizona 85364
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Yuma, AZ
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