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
El Paso, Texas 79902
1375
mi
from 98109
El Paso, TX
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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...
962
mi
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Los Angeles, CA
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1768
mi
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Austin, TX
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Carbondale, Illinois 62902
1799
mi
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Carbondale, IL
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Chattanooga, Tennessee 37403
2083
mi
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Chattanooga, TN
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Clearwater, Florida 33756
2512
mi
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Clearwater, FL
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180 East Broad Street
Columbus, Ohio 43214
2008
mi
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Columbus, OH
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Coon Rapids, Minnesota 55433
1385
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Coon Rapids, MN
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1606
mi
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Davenport, IA
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Dearborn, Michigan 48126
1927
mi
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Dearborn, MI
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Denver, Colorado 80220
1023
mi
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Denver, CO
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Denver, Colorado 80220
1020
mi
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Denver, CO
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Detroit, Michigan 48236
1937
mi
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Detroit, MI
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1937
mi
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Galveston, TX
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Gilbert, Arizona 85297
1136
mi
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Gilbert, AZ
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Glendale, Arizona 85306
1100
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...
2429
mi
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Hartford, CT
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1892
mi
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Houston, TX
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Hudson, Florida 34766
2236
mi
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Hudson, FL
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Jacksonville, Florida 32216
2457
mi
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Jacksonville, FL
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Kansas City, Missouri 64111
1504
mi
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Kansas City, MO
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Kingsport, Tennessee 37660
2151
mi
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Kingsport, TN
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Knoxville, Tennessee 37909
2105
mi
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Knoxville, TN
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Lakeland, Florida 33805
2543
mi
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Lakeland, FL
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Lakewood, Colorado 80228
1015
mi
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Lakewood, CO
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Largo, Florida 33770
2513
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Largo, FL
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1 Saint Joseph Drive
Lexington, Kentucky 40504
2004
mi
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Lexington, KY
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Little Rock, Arkansas 72211
1776
mi
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Little Rock, AR
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Lumberton, North Carolina 28358
2390
mi
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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...
2732
mi
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Miami, FL
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Miami Beach, Florida 33140
2732
mi
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Miami Beach, FL
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New Braunfels, Texas 78130
1786
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...
2432
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New Haven, CT
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New York, New York 10001
877
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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...
2401
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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
2547
mi
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Orlando, FL
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Pensacola, Florida 32204
2200
mi
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Pensacola, FL
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Phoenix, Arizona
1116
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Phoenix, AZ
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Raleigh, North Carolina 27607
2361
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Raleigh, NC
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Rockville, Maryland 20850
2307
mi
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Rockville, MD
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Saginaw, Michigan 48604
1858
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Saginaw, MI
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1915
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San Antonio, TX
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Schaumburg, Illinois 60173
1709
mi
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Schaumburg, IL
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Sioux Falls, South Dakota 65104
1263
mi
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Sioux Falls, SD
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Southaven, Mississippi 38671
1873
mi
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Southaven, MS
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Springfield, Illinois 62701
1705
mi
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Springfield, IL
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Springfield, Missouri 65802
1634
mi
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Springfield, MO
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Sugar Land, Texas 77479
1887
mi
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Sugar Land, TX
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Tampa, Florida 33613
2527
mi
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Tampa, FL
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Tulsa, Oklahoma 74104
1560
mi
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Tulsa, OK
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1763
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Tyler, TX
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Waco, Texas 76712
1726
mi
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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
1794
mi
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Wyoming, MI
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