Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes
NCT ID: NCT01855412
Last Updated: 2023-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
1204 participants
OBSERVATIONAL
2013-05-31
2019-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Claudication (Rutherford 2-3)
Patients who have been diagnosed with PAD and are classified as on the Rutherford Scale as Rutherford 2-3. Patients may be treated with any FDA-cleared endovascular PAD treatment.
PAD endovascular treatments
All FDA-cleared endovascular PAD treatments
CLI Rutherford 4-5
Patients who have been diagnosed with PAD and classified on the Rutherford Scale as Rutherford 4-5. Patients may be treated with any FDA-cleared endovascular PAD treatment.
PAD endovascular treatments
All FDA-cleared endovascular PAD treatments
CLI Rutherford 6
Patients who have been diagnosed with PAD and classified on the Rutherford Scale as Rutherford 6. Patients may be treated with any FDA-cleared endovascular PAD treatment.
PAD endovascular treatments
All FDA-cleared endovascular PAD treatments
Interventions
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PAD endovascular treatments
All FDA-cleared endovascular PAD treatments
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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William Gray, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Gary Ansel, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio Health
George Adams, MD
Role: PRINCIPAL_INVESTIGATOR
Rex Healthcare
Jihad Mustapha, MD
Role: PRINCIPAL_INVESTIGATOR
Advanced Cardiac & Vascular Centers
Locations
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Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Phoenix Heart Cardiovascular
Glendale, Arizona, United States
St. Luke's Medical Center
Phoenix, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Cedars-Sinai Heart Institute
Los Angeles, California, United States
Denver Heart
Denver, Colorado, United States
VA Eastern Colorado Healthcare System
Denver, Colorado, United States
Colorado Heart and Vascular, PC
Lakewood, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
The Heart Institute of Largo
Largo, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Mount Sinai Medical Center Heart Institute
Miami Beach, Florida, United States
Florida Hospital
Orlando, Florida, United States
Coastal Vascular and Intervention
Pensacola, Florida, United States
Pepin Heart Institute
Tampa, Florida, United States
Memorial Hospital Carbondale
Carbondale, Illinois, United States
Chicago Vascular Clinic
Schaumburg, Illinois, United States
St. John's Hospital Springfield
Springfield, Illinois, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
St. Joseph Hospital
Lexington, Kentucky, United States
Shady Grove Adventist Hospital
Rockville, Maryland, United States
Michigan Outpatient Vascular Institute
Dearborn, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Mid-Michigan Heart and Vascular Center
Saginaw, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Metropolitan Heart and Vascular Institute
Coon Rapids, Minnesota, United States
Stern Cardiovascular Foundation
Southaven, Mississippi, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Cox Health System
Springfield, Missouri, United States
Gotham Cardiovascular Research
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Duke University Hospital
Lumberton, North Carolina, United States
Rex Heathcare
Raleigh, North Carolina, United States
Ohio Health
Columbus, Ohio, United States
St. John Health System
Tulsa, Oklahoma, United States
Sanford Research
Sioux Falls, South Dakota, United States
University Surgical Associates
Chattanooga, Tennessee, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
Premier Surgical Associates
Knoxville, Tennessee, United States
Cardiothoracic and Vascular Surgeons, P.A.
Austin, Texas, United States
El Paso Cardiology Associates
El Paso, Texas, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Mission Research Institute
New Braunfels, Texas, United States
San Antonio Endovascular & Heart Institute
San Antonio, Texas, United States
Houston Methodist Research Institute Sugar Land
Sugar Land, Texas, United States
Cardiovascular Associates of East Texas
Tyler, Texas, United States
Providence Health Services
Waco, Texas, United States
Countries
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References
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Adams GL, Mustapha J, Gray W, Hargus NJ, Martinsen BJ, Ansel G, Jaff MR. The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease. Am Heart J. 2016 Apr;174:14-21. doi: 10.1016/j.ahj.2015.12.013. Epub 2015 Dec 30.
Mustapha J, Gray W, Martinsen BJ, Bolduan RW, Adams GL, Ansel G, Jaff MR. One-Year Results of the LIBERTY 360 Study: Evaluation of Acute and Midterm Clinical Outcomes of Peripheral Endovascular Device Interventions. J Endovasc Ther. 2019 Apr;26(2):143-154. doi: 10.1177/1526602819827295. Epub 2019 Feb 6.
Mustapha JA, Igyarto Z, O'Connor D, Armstrong EJ, Iorio AR, Driver VR, Saab F, Behrens AN, Martinsen BJ, Adams GL. One-Year Outcomes of Peripheral Endovascular Device Intervention in Critical Limb Ischemia Patients: Sub-Analysis of the LIBERTY 360 Study. Vasc Health Risk Manag. 2020 Feb 10;16:57-66. doi: 10.2147/VHRM.S230934. eCollection 2020.
Giannopoulos S, Secemsky EA, Mustapha JA, Adams G, Beasley RE, Pliagas G, Armstrong EJ. Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia. J Endovasc Ther. 2020 Oct;27(5):714-725. doi: 10.1177/1526602820935611. Epub 2020 Jul 3.
Giannopoulos S, Shammas NW, Cawich I, Staniloae CS, Adams GL, Armstrong EJ. Sex-Related Differences in the Outcomes of Endovascular Interventions for Chronic Limb-Threatening Ischemia: Results from the LIBERTY 360 Study. Vasc Health Risk Manag. 2020 Jul 8;16:271-284. doi: 10.2147/VHRM.S246528. eCollection 2020.
Narcisse DI, Weissler EH, Rymer JA, Armstrong EJ, Secemsky EA, Gray WA, Mustapha JA, Adams GL, Ansel GM, Patel MR, Jones WS. The impact of chronic kidney disease on outcomes following peripheral vascular intervention. Clin Cardiol. 2020 Nov;43(11):1308-1316. doi: 10.1002/clc.23444. Epub 2020 Aug 11.
Giannopoulos S, Mustapha J, Gray WA, Ansel G, Adams G, Secemsky EA, Armstrong EJ. Three-Year Outcomes From the LIBERTY 360 Study of Endovascular Interventions for Peripheral Artery Disease Stratified by Rutherford Category. J Endovasc Ther. 2021 Apr;28(2):262-274. doi: 10.1177/1526602820962972. Epub 2020 Oct 5.
Weissler EH, Narcisse DI, Rymer JA, Armstrong EJ, Secemsky E, Gray WA, Mustapha JA, Adams GL, Ansel GM, Patel MR, Jones WS. Characteristics and Outcomes of Patients With Diabetes Mellitus Undergoing Peripheral Vascular Intervention for Infrainguinal Symptomatic Peripheral Artery Disease. Vasc Endovascular Surg. 2021 Feb;55(2):124-134. doi: 10.1177/1538574420968671. Epub 2020 Oct 23.
Magnuson EA, Li H, Vilain K, Armstrong EJ, Secemsky EA, Giannopoulos S, Adams GL, Mustapha J, Cohen DJ; LIBERTY 360 degrees Trial Investigators. Two-year PAD-related health care costs in patients undergoing lower extremity endovascular revascularization: results from the LIBERTY 360 degrees trial. J Med Econ. 2021 Jan-Dec;24(1):570-580. doi: 10.1080/13696998.2021.1917141.
Giannopoulos S, Pliagas G, Armstrong EJ. Procedural and 3-Year Outcomes of Peripheral Vascular Interventions Performed in Office-Based Labs: LIBERTY 360 Sub-Analysis. J Invasive Cardiol. 2021 May;33(5):E365-E377. doi: 10.25270/jic/20.00594.
Giannopoulos, S, Fakorede FA, Cawich I, Dishmon D, Horne A, Raja ML, Mustapha JA, Adams GL, Armstrong EJ. Racial Disparities in Risk for Major Amputation or Death After Endovascular Interventions for Peripheral Artery Disease: A LIBERTY 360 Study. J Crit Limb Ischemia. 2021 June;1(2):E62-E72.
Salahuddin T, Giannopoulos S, Adams G, Armstrong EJ. Anterior, posterior, or all-vessel infrapopliteal revascularization in patients with moderate-severe claudication: Insights from the LIBERTY 360 study. Catheter Cardiovasc Interv. 2021 Sep;98(3):559-569. doi: 10.1002/ccd.29780. Epub 2021 May 31.
Jammeh ML, Suggs J, Adams GL, Armstrong EJ, Mustapha J, Zayed MA. Outcomes of Orbital Atherectomy in Patients with Critical Limb Threatening Ischemia and Diabetes. J Crit Limb Ischemia. 2022 Jun;2(2):E29-E37. Epub 2022 Apr 12.
Metser G, Puma J, Mustapha J, Adams GL, Ratcliffe J, Khullar P, Rosero JHC, Armstrong EJ, Zayed M, Green P. Clinical Outcomes of Additional Below-The-Ankle Intervention Compared to Below-The-Knee Intervention Alone: A Post-Hoc Analysis of a Prospective Multicenter Study. J Endovasc Ther. 2023 Oct;30(5):711-720. doi: 10.1177/15266028221092981. Epub 2022 May 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLN-0001-P
Identifier Type: -
Identifier Source: org_study_id
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