Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/23/2018
Start Date:May 2013
End Date:December 2020

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LIBERTY 360: Prospective, Observational, Multi-Center Clinical Study to Evaluate Acute and Long Term Clinical and Economic Outcomes of Endovascular Device Intervention in Patients With Distal Outflow Peripheral Arterial Disease (PAD)

The purpose of this study is to evaluate acute and long term clinical and economic outcomes
of endovascular procedures to treat Peripheral Arterial Disease (PAD).

This is a prospective, observational, multi-center, clinical study examining predictors of
clinical outcomes for patients undergoing endovascular treatment of lesions within or
extending into the target area (10 cm above the medial epicondyle to the digital arteries).
This includes disease in a vessel located within or extending into the distal superficial
femoral artery (SFA), popliteal (POP), tibial peroneal trunk (TPT), anterior tibial (AT),
posterior tibial (PT), and peroneal tibial (PR) arteries.

Inclusion Criteria:

1. Subject's age ≥ 18 years.

2. Subject presents with a Rutherford classification of 2 to 6.

3. Subject presents with clinical evidence of PAD requiring endovascular intervention on
one or both limbs that includes a target lesion in a native vessel located within or
extending into 10 cm above the medial epicondyle to the digital arteries.

- If subject presents with bilateral disease, the first limb treated with a lesion
in the target area will be considered the target limb.

- For subjects with one or more wounds on the target limb, the target lesion(s)
should be considered the lesion(s) in the vessel(s) that provide(s) blood flow to
the wound(s).

4. Subject has at least one lesion in a native vessel located within or extending into
the target area that is crossed and treated with an endovascular device.

Exclusion Criteria:

1. Subject is unwilling or unable to sign the IRB-approved informed consent form (ICF).

2. Subject is unable to understand or comply with the study protocol requirements.

3. Subject is currently participating in an investigational drug or other device study
that can clinically interfere with the endpoints of this study.

4. Subject requires a conversion from endovascular intervention to a surgical bypass
graft for any lesion(s) in the target area, as determined by the Investigator.

5. Subject has an in-stent restenosis in the target area, and this lesion is the only one
requiring treatment.

6. Subject is pregnant or planning to become pregnant within the study period.

7. Subject has an anticipated life span of less than one (1) year.
We found this trial at
53
sites
1 Saint Joseph Drive
Lexington, Kentucky 40504
155
mi
from 43215
Lexington, KY
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
1972
mi
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Los Angeles, CA
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1063
mi
from 43215
Austin, TX
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Carbondale, Illinois 62902
367
mi
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Carbondale, IL
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Chattanooga, Tennessee 37403
361
mi
from 43215
Chattanooga, TN
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Clearwater, Florida 33756
830
mi
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Clearwater, FL
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180 East Broad Street
Columbus, Ohio 43214
1
mi
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Columbus, OH
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Coon Rapids, Minnesota 55433
634
mi
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Coon Rapids, MN
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409
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Davenport, IA
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Dearborn, Michigan 48126
164
mi
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Dearborn, MI
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Denver, Colorado 80220
1158
mi
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Denver, CO
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Denver, Colorado 80220
1161
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Denver, CO
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Detroit, Michigan 48236
170
mi
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Detroit, MI
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El Paso, Texas 79902
1424
mi
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El Paso, TX
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993
mi
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Galveston, TX
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Gilbert, Arizona 85297
1648
mi
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Gilbert, AZ
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Glendale, Arizona 85306
1670
mi
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Glendale, AZ
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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...
554
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Hartford, CT
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995
mi
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Houston, TX
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Hudson, Florida 34766
649
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Hudson, FL
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Jacksonville, Florida 32216
673
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Jacksonville, FL
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Kansas City, Missouri 64111
619
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Kansas City, MO
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Kingsport, Tennessee 37660
237
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Kingsport, TN
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Knoxville, Tennessee 37909
283
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Knoxville, TN
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Lakeland, Florida 33805
822
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Lakeland, FL
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Lakewood, Colorado 80228
1171
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Lakewood, CO
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Largo, Florida 33770
832
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Largo, FL
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Little Rock, Arkansas 72211
628
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Little Rock, AR
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Lumberton, North Carolina 28358
430
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Lumberton, NC
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8900 N Kendall Dr
Miami, Florida 33176
(786) 596-1960
Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
996
mi
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Miami, FL
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Miami Beach, Florida 33140
991
mi
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Miami Beach, FL
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New Braunfels, Texas 78130
1108
mi
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New Braunfels, TX
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
537
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New Haven, CT
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New York, New York 10001
1760
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New York, NY
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
477
mi
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New York, NY
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
793
mi
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Orlando, FL
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Pensacola, Florida 32204
700
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Pensacola, FL
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Phoenix, Arizona
1662
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Phoenix, AZ
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Raleigh, North Carolina 27607
374
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Raleigh, NC
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Rockville, Maryland 20850
316
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Rockville, MD
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Saginaw, Michigan 48604
249
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Saginaw, MI
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1146
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San Antonio, TX
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Schaumburg, Illinois 60173
298
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Schaumburg, IL
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Sioux Falls, South Dakota 65104
746
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Sioux Falls, SD
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Southaven, Mississippi 38671
513
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Southaven, MS
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Springfield, Illinois 62701
351
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Springfield, IL
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Springfield, Missouri 65802
585
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Springfield, MO
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Sugar Land, Texas 77479
1009
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Sugar Land, TX
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Tampa, Florida 33613
831
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Tampa, FL
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Tulsa, Oklahoma 74104
750
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Tulsa, OK
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862
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Tyler, TX
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Waco, Texas 76712
985
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Waco, TX
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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
246
mi
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Wyoming, MI
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