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
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Hudson, Florida 34766
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
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Austin, TX
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Carbondale, Illinois 62902
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Chattanooga, Tennessee 37403
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Clearwater, Florida 33756
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180 East Broad Street
Columbus, Ohio 43214
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Coon Rapids, Minnesota 55433
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Dearborn, Michigan 48126
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Denver, Colorado 80220
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Denver, Colorado 80220
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Detroit, Michigan 48236
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El Paso, Texas 79902
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Gilbert, Arizona 85297
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Glendale, Arizona 85306
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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...
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Jacksonville, Florida 32216
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Kansas City, Missouri 64111
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Kingsport, Tennessee 37660
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Knoxville, Tennessee 37909
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Lakeland, Florida 33805
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Lakewood, Colorado 80228
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Largo, Florida 33770
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1 Saint Joseph Drive
Lexington, Kentucky 40504
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Little Rock, Arkansas 72211
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Lumberton, North Carolina 28358
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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...
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Miami Beach, Florida 33140
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New Braunfels, Texas 78130
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
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New York, New York 10001
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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...
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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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Pensacola, Florida 32204
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Phoenix, Arizona
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Raleigh, North Carolina 27607
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Rockville, Maryland 20850
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Saginaw, Michigan 48604
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Schaumburg, Illinois 60173
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Sioux Falls, South Dakota 65104
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Southaven, Mississippi 38671
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Springfield, Illinois 62701
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Springfield, Missouri 65802
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Sugar Land, Texas 77479
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Tampa, Florida 33613
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Tulsa, Oklahoma 74104
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Waco, Texas 76712
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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
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