Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:3/9/2019
Start Date:April 23, 2015
End Date:October 2019

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A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter in Arteries of the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) (SAFE-DCB U.S. Registry)

The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB
PTA Catheter in a heterogeneous patient population in a real world and on-label clinical
application.

The registry is a prospective, multicenter, single arm post-market real-world registry in the
U.S. assessing the clinical use, safety and outcomes of the Lutonix 035 DCB Catheter in the
Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects will be
followed for up to three year's post-index procedure.

Inclusion Criteria:

1. The subject provides written informed consent using an Informed Consent Form (ICF)
that is reviewed and approved by the Institutional Review Board (IRB) for the site.

2. The subject agrees to comply with the protocol-mandated follow-up procedures and
visits.

3. The subject is ≥ 21 years old.

4. The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB
Catheter according to IFU.

Exclusion Criteria:

1. The subject is unable or unwilling to provide informed consent.

2. The subject is unable or unwilling to comply with the patient registry protocol
follow-up procedures and visits.

3. The subject has another medical condition or is currently participating in an
investigational drug or an investigational device study that, which, in the opinion of
the Investigator, may cause him/her to be non-compliant with the protocol, confounds
the data interpretation, or is associated with a life expectancy insufficient to allow
for the completion of patient registry procedures and follow-up.
We found this trial at
73
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2116
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Erie, PA
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
1919
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Atlanta, GA
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4085 University Blvd S # 1
Jacksonville, Florida 32216
2134
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Jacksonville, FL
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24 Sturtevant St
Orlando, Florida 32806
2184
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Orlando, FL
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
2614
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Portland, ME
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Alexander City, Alabama 35010
1840
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Alexander City, AL
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Annapolis, Maryland 21401
2309
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Annapolis, MD
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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...
1918
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Atlanta, GA
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1211
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Austin, TX
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Austin, Texas 78705
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Austin, TX
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Bartlesville, Oklahoma 74006
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Bartlesville, OK
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Bellevue, Washington 98004
960
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Bellevue, WA
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Boynton Beach, Florida 33435
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Boynton Beach, FL
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Bradenton, Florida 34205
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Bryn Mawr, Pennsylvania 19010
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Chandler, Arizona 85224
356
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Chandler, AZ
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Charleston, West Virginia 25304
2038
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Charleston, WV
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3000 Hospital Drive
Cincinnati, Ohio 45211
1899
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Cincinnati, OH
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2116
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Clearwater, FL
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1576
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Davenport, IA
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Detroit, Michigan 48236
1974
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Detroit, MI
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Detroit, Michigan 48202
1965
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Detroit, MI
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El Paso, Texas 79902
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El Paso, TX
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Flushing, New York 11355
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Flushing, NY
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Gastonia, North Carolina 28054
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Germantown, Tennessee 38138
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Germantown, TN
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Green Bay, Wisconsin 54301
1745
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Green Bay, WI
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Greensboro, North Carolina 27401
2151
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Greensboro, NC
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
2430
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Hackensack, NJ
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Haddon Heights, New Jersey 08035
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Haddon Heights, NJ
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Harrisburg, Pennsylvania 17110
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Harrisburg, PA
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
2497
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Hartford, CT
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Hattiesburg, Mississippi 39402
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Honolulu, Hawaii 96819
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Houston, TX
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Hutchinson, KS
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Hyannis, Massachusetts 02601
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Indianapolis, Indiana 46237
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Indianapolis, IN
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
1528
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Iowa City, IA
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Jacksonville, Florida 32256
2138
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1102 W 32nd St
Joplin, Missouri 64804
(417) 347-1111
Freeman Health System Freeman in Joplin, Missouri, is a 485-bed, three-hospital system providing comprehensive healthcare...
1333
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Lakewood, Colorado 80228
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Lansing, Michigan 48912
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Madison, Wisconsin 53713
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Marquette, Michigan 49855
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Memphis, Tennessee 38120
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Milwaukee, Wisconsin 53211
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Neptune, New Jersey 07754
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New Bern, North Carolina 28562
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New York, New York 10003
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Oklahoma City, Oklahoma 73104
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Oklahoma City, Oklahoma
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Orangeburg, South Carolina 29118
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Peoria, IL
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Phoenix, Arizona 85006
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Pittsburgh, Pennsylvania 15212
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Portland, Oregon 97213
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Providence, Rhode Island 02906
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Raleigh, North Carolina 27607
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Richmond, Virginia 23225
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San Diego, California 92093
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Springfield, Illinois 62701
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Syracuse, New York 13210
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1987
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Toledo, Ohio 43606
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105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
1861
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Virginia Beach, Virginia 23542
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Washington, District of Columbia 20010
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Wormleysburg, Pennsylvania 17043
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