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

Use our guide to learn which trials are right for you!

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
Yuma Regional Medical Center
Yuma, Arizona 85364
?
mi
from
Yuma, AZ
Click here to add this to my saved trials
Baptist Cardiac and Vascular Institute
8900 North Kendall Drive
Miami, Florida 33176
?
mi
from
Miami, FL
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
Mission Hospital, Inc
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Heritage Valley Health System
Beaver, Pennsylvania 15009
?
mi
from
Beaver, PA
Click here to add this to my saved trials
Deborah Heart and Lung Center
Browns Mills, New Jersey 08015
?
mi
from
Browns Mills, NJ
Click here to add this to my saved trials
CAMC Clinical Trial Center
Charleston, West Virginia 25304
?
mi
from
Charleston, WV
Click here to add this to my saved trials
University of Virginia
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
University Surgical Associates, LLC
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
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...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Providence Cardiology LLC
Columbia, South Carolina 29204
?
mi
from
Columbia, SC
Click here to add this to my saved trials
OhioHealth Research Institute
Columbus, Ohio 43214
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Texas Health & Research Education Institution
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Central Iowa Hospital Corporation
Des Moines, Iowa 50309
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
El Paso Cardiology Associates
El Paso, Texas 79902
?
mi
from
El Paso, TX
Click here to add this to my saved trials
North Ohio Research, Ltd.
Elyria, Ohio 44035
?
mi
from
Elyria, OH
Click here to add this to my saved trials
St. Joseph Hospital
Fort Wayne, Indiana 46802
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Mission Cardiovascular Research Institute
Fremont, California
?
mi
from
Fremont, CA
Click here to add this to my saved trials
Cardiovascular Research of North Florida
Gainesville, Florida
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
LKH Univ. - Klinikum Graz
Graz, 8036
?
mi
from
Graz,
Click here to add this to my saved trials
University of Texas Health Science Center
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jackson Heart Clinic
Jackson, Mississippi 39216
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Wellmont Holston Area Medical Center
Kingsport, Tennessee 37660
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
Premier Surgical Associates
Knoxville, Tennessee 37909
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Good Samaritan Hospital Los Angeles
Los Angeles, California 90017
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Medical Center of the Rockies
Loveland, Colorado 80538
?
mi
from
Loveland, CO
Click here to add this to my saved trials
Aurora Health Care
Milwaukee, Wisconsin 53215
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
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...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Sentara Vascular Specialist
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois 60181
?
mi
from
Oakbrook Terrace, IL
Click here to add this to my saved trials
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma 73210
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Coastal Vascular & Interventional, PLLC.
Pensacola, Florida 32204
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan
?
mi
from
Petoskey, MI
Click here to add this to my saved trials
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...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Providence Heart & Vascular Institute
Portland, Oregon 97220
?
mi
from
Portland, OR
Click here to add this to my saved trials
Rex Hospital, Inc
Raleigh, North Carolina 27607
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Wake Heart Research
Raleigh, North Carolina 27610
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Sanford Health Vascular Associates
Sioux Falls, South Dakota 57117
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Jobst Vascular Institute
Toledo, Ohio 43606
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania 17043
?
mi
from
Wormleysburg, PA
Click here to add this to my saved trials
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
?
mi
from
Wyoming, MI
Click here to add this to my saved trials