Clinical trial NCT01855412: Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Occlusive Disease
Keywords: PAD
LIBERTY
Observational
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-05-16
Enrollment: 1204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been determined by their physician to require endovascular device treatment for their PAD.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedural Success of Endovascular PAD Treatment(s)
timeFrame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
measure: Lesion Success of Endovascular PAD Treatment(s)
timeFrame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
measure: Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years
timeFrame: One (1) year and three (3) years post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Glendale
country: United States
facility: Phoenix Heart Cardiovascular
state: Arizona
city: Phoenix
country: United States
facility: St. Luke's Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Cedars-Sinai Heart Institute
state: California
city: Denver
country: United States
facility: Denver Heart
state: Colorado
city: Denver
country: United States
facility: VA Eastern Colorado Healthcare System
state: Colorado
city: Lakewood
country: United States
facility: Colorado Heart and Vascular, PC
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Largo
country: United States
facility: The Heart Institute of Largo
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center Heart Institute
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Intervention
state: Florida
city: Tampa
country: United States
facility: Pepin Heart Institute
state: Florida
city: Carbondale
country: United States
facility: Memorial Hospital Carbondale
state: Illinois
city: Schaumburg
country: United States
facility: Chicago Vascular Clinic
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital Springfield
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Lexington
country: United States
facility: St. Joseph Hospital
state: Kentucky
city: Rockville
country: United States
facility: Shady Grove Adventist Hospital
state: Maryland
city: Dearborn
country: United States
facility: Michigan Outpatient Vascular Institute
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Saginaw
country: United States
facility: Mid-Michigan Heart and Vascular Center
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Metropolitan Heart and Vascular Institute
state: Minnesota
city: Southaven
country: United States
facility: Stern Cardiovascular Foundation
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Springfield
country: United States
facility: Cox Health System
state: Missouri
city: New York
country: United States
facility: Gotham Cardiovascular Research
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Lumberton
country: United States
facility: Duke University Hospital
state: North Carolina
city: Raleigh
country: United States
facility: Rex Heathcare
state: North Carolina
city: Columbus
country: United States
facility: Ohio Health
state: Ohio
city: Tulsa
country: United States
facility: St. John Health System
state: Oklahoma
city: Sioux Falls
country: United States
facility: Sanford Research
state: South Dakota
city: Chattanooga
country: United States
facility: University Surgical Associates
state: Tennessee
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Knoxville
country: United States
facility: Premier Surgical Associates
state: Tennessee
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons, P.A.
state: Texas
city: El Paso
country: United States
facility: El Paso Cardiology Associates
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: New Braunfels
country: United States
facility: Mission Research Institute
state: Texas
city: San Antonio
country: United States
facility: San Antonio Endovascular & Heart Institute
state: Texas
city: Sugar Land
country: United States
facility: Houston Methodist Research Institute Sugar Land
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas
state: Texas
city: Waco
country: United States
facility: Providence Health Services
state: Texas
Study officials:
affiliation: Columbia University
name: William Gray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio Health
name: Gary Ansel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rex Healthcare
name: George Adams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Cardiac & Vascular Centers
name: Jihad Mustapha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.