Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes

NCT01855412 | Completed Results

• 1 other identifier: CLN-0001-P
• Study Type: observational
• Target: 1,204
• Locations: 1 country
• Sites: 52

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).

Conditions

Peripheral Arterial Occlusive Disease

Keywords

PAD; LIBERTY; Observational

Outcome Measures

Primary Outcomes (3)

• Procedural Success of Endovascular PAD Treatment(s)

  Final post-procedural result of \<50% residual stenosis for all treated lesions for a participant during index procedure and without angiographic complications as determined by the Angiographic Core Laboratory.

  Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours

• Lesion Success of Endovascular PAD Treatment(s)

  Final post-procedural result of \<50% residual stenosis for a given lesion treated during index procedure without angiographic complications as determined by the Angiographic Core Laboratory.

  Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours

• Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years

  A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event through 1 year and 3 years. 1- and 3-year MAE is composed of: * Death within 30 days of index procedure * Unplanned major (above the ankle) amputation of the target limb * Clinically-driven TVR (Target Vessel Revascularization) of the target limb

  One (1) year and three (3) years post-procedure

Study Arms (3)

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.

Other: PAD endovascular 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.

Other: PAD endovascular 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.

Other: PAD endovascular treatments

Interventions

PAD endovascular treatments OTHER

All FDA-cleared endovascular PAD treatments

CLI Rutherford 4-5; CLI Rutherford 6; Claudication (Rutherford 2-3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been determined by their physician to require endovascular device treatment for their PAD.

You may qualify if:

• Subject's age ≥ 18 years.
• Subject presents with a Rutherford classification of 2 to 6.
• 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).
• 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.

You may not qualify if:

• Subject is unwilling or unable to sign the IRB-approved informed consent form (ICF).
• Subject is unable to understand or comply with the study protocol requirements.
• Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this study.
• 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.
• Subject has an in-stent restenosis in the target area, and this lesion is the only one requiring treatment.
• Subject is pregnant or planning to become pregnant within the study period.
• Subject has an anticipated life span of less than one (1) year.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (52)

Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

Location

Phoenix Heart Cardiovascular

Glendale, Arizona, 85306, United States

Location

St. Luke's Medical Center

Phoenix, Arizona, 85006, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Cedars-Sinai Heart Institute

Los Angeles, California, 90048, United States

Location

Denver Heart

Denver, Colorado, 80220, United States

Location

VA Eastern Colorado Healthcare System

Denver, Colorado, 80220, United States

Location

Colorado Heart and Vascular, PC

Lakewood, Colorado, 80228, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

The Heart Institute of Largo

Largo, Florida, 33770, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Mount Sinai Medical Center Heart Institute

Miami Beach, Florida, 33140, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Coastal Vascular and Intervention

Pensacola, Florida, 32504, United States

Location

Pepin Heart Institute

Tampa, Florida, 33613, United States

Location

Memorial Hospital Carbondale

Carbondale, Illinois, 62902, United States

Location

Chicago Vascular Clinic

Schaumburg, Illinois, 60173, United States

Location

St. John's Hospital Springfield

Springfield, Illinois, 62701, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

St. Joseph Hospital

Lexington, Kentucky, 40504, United States

Location

Shady Grove Adventist Hospital

Rockville, Maryland, 20850, United States

Location

Michigan Outpatient Vascular Institute

Dearborn, Michigan, 48126, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Mid-Michigan Heart and Vascular Center

Saginaw, Michigan, 48604, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Metropolitan Heart and Vascular Institute

Coon Rapids, Minnesota, 55433, United States

Location

Stern Cardiovascular Foundation

Southaven, Mississippi, 38671, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Cox Health System

Springfield, Missouri, 65802, United States

Location

Gotham Cardiovascular Research

New York, New York, 10001, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University Hospital

Lumberton, North Carolina, 28358, United States

Location

Rex Heathcare

Raleigh, North Carolina, 27607, United States

Location

Ohio Health

Columbus, Ohio, 43214, United States

Location

St. John Health System

Tulsa, Oklahoma, 74104, United States

Location

Sanford Research

Sioux Falls, South Dakota, 57104, United States

Location

University Surgical Associates

Chattanooga, Tennessee, 37403, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Premier Surgical Associates

Knoxville, Tennessee, 37909, United States

Location

Cardiothoracic and Vascular Surgeons, P.A.

Austin, Texas, 78756, United States

Location

El Paso Cardiology Associates

El Paso, Texas, 79902, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Mission Research Institute

New Braunfels, Texas, 78130, United States

Location

San Antonio Endovascular & Heart Institute

San Antonio, Texas, 78358, United States

Location

Houston Methodist Research Institute Sugar Land

Sugar Land, Texas, 77479, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Location

Providence Health Services

Waco, Texas, 76712, United States

Location

Related Publications (14)

• 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.

  PMID: 26995365 BACKGROUND

• 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.

  PMID: 30722718 RESULT

• 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.

  PMID: 32103970 RESULT

• 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.

  PMID: 32618486 RESULT

• 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.

  PMID: 32753875 RESULT

• 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.

  PMID: 32780436 RESULT

• 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.

  PMID: 33016805 RESULT

• 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.

  PMID: 33094679 RESULT

• 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.

  PMID: 33866936 RESULT

• 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.

  PMID: 33932282 RESULT

• 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.

  RESULT

• 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.

  PMID: 34057276 RESULT

• 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.

  PMID: 37066103 RESULT

• 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.

  PMID: 35503774 RESULT

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Results Point of Contact

• Title: Clinical Trials Manager
• Organization: Cardiovascular Systems, Inc.

clinicaltrials_csi@csi360.com

651.259.2500

Study Officials

• William Gray, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Gary Ansel, MD

  Ohio Health

  PRINCIPAL INVESTIGATOR

• George Adams, MD

  Rex Healthcare

  PRINCIPAL INVESTIGATOR

• Jihad Mustapha, MD

  Advanced Cardiac & Vascular Centers

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 16, 2013
• Study Start: May 1, 2013
• Primary Completion: April 11, 2019
• Study Completion: April 11, 2019
• Last Updated: July 18, 2023
• Results First Posted: May 18, 2021

Record last verified: 2023-07

Locations

US (52)