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
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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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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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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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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Pittsburgh, PA
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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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from
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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