Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes (LIBERTY)

July 14, 2023 updated by: Abbott Medical Devices

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Mercy Gilbert Medical Center
      • Glendale, Arizona, United States, 85306
        • Phoenix Heart Cardiovascular
      • Phoenix, Arizona, United States, 85006
        • St. Luke's Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Heart Institute
    • Colorado
      • Denver, Colorado, United States, 80220
        • VA Eastern Colorado Healthcare System
      • Denver, Colorado, United States, 80220
        • Denver Heart
      • Lakewood, Colorado, United States, 80228
        • Colorado Heart and Vascular, PC
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Haven, Connecticut, United States, 06510
        • Yale-New Haven Hospital
    • Florida
      • Clearwater, Florida, United States, 33756
        • Clearwater Cardiovascular Consultants
      • Jacksonville, Florida, United States, 32216
        • First Coast Cardiovascular Institute
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Medical Center
      • Largo, Florida, United States, 33770
        • The Heart Institute of Largo
      • Miami, Florida, United States, 33176
        • Baptist Cardiac and Vascular Institute
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center Heart Institute
      • Orlando, Florida, United States, 32803
        • Florida Hospital
      • Pensacola, Florida, United States, 32504
        • Coastal Vascular and Intervention
      • Tampa, Florida, United States, 33613
        • Pepin Heart Institute
    • Illinois
      • Carbondale, Illinois, United States, 62902
        • Memorial Hospital Carbondale
      • Schaumburg, Illinois, United States, 60173
        • Chicago Vascular Clinic
      • Springfield, Illinois, United States, 62701
        • St. John's Hospital Springfield
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Midwest Cardiovascular Research Foundation
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • St. Joseph Hospital
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Shady Grove Adventist Hospital
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Michigan Outpatient Vascular Institute
      • Detroit, Michigan, United States, 48236
        • St. John Hospital and Medical Center
      • Saginaw, Michigan, United States, 48604
        • Mid-Michigan Heart and Vascular Center
      • Wyoming, Michigan, United States, 49519
        • Metro Health Hospital
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Metropolitan Heart and Vascular Institute
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Stern Cardiovascular Foundation
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
      • Springfield, Missouri, United States, 65802
        • Cox Health System
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10001
        • Gotham Cardiovascular Research
    • North Carolina
      • Lumberton, North Carolina, United States, 28358
        • Duke University Hospital
      • Raleigh, North Carolina, United States, 27607
        • Rex Heathcare
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Ohio Health
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • St. John Health System
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • University Surgical Associates
      • Kingsport, Tennessee, United States, 37660
        • Wellmont CVA Heart Institute
      • Knoxville, Tennessee, United States, 37909
        • Premier Surgical Associates
    • Texas
      • Austin, Texas, United States, 78756
        • Cardiothoracic and Vascular Surgeons, P.A.
      • El Paso, Texas, United States, 79902
        • El Paso Cardiology Associates
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch at Galveston
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Institute
      • New Braunfels, Texas, United States, 78130
        • Mission Research Institute
      • San Antonio, Texas, United States, 78358
        • San Antonio Endovascular & Heart Institute
      • Sugar Land, Texas, United States, 77479
        • Houston Methodist Research Institute Sugar Land
      • Tyler, Texas, United States, 75701
        • Cardiovascular Associates of East Texas
      • Waco, Texas, United States, 76712
        • Providence Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other: 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.
Other: PAD endovascular treatments
All FDA-cleared endovascular PAD treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural Success of Endovascular PAD Treatment(s)
Time Frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
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)
Time Frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
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
Time Frame: One (1) year and three (3) years post-procedure

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Jihad Mustapha, MD, Advanced Cardiac & Vascular Centers
  • Principal Investigator: Gary Ansel, MD, Ohio Health
  • Principal Investigator: George Adams, MD, Rex Healthcare
  • Principal Investigator: William Gray, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

April 11, 2019

Study Completion (Actual)

April 11, 2019

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimated)

May 16, 2013

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-0001-P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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