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

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ClinicalTrials.gov Identifier: NCT01855412
Recruitment Status : Completed
First Posted : May 16, 2013
Results First Posted : May 18, 2021
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc

Study Description
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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).

Condition or disease Intervention/treatment
Peripheral Arterial Occlusive Disease Other: PAD endovascular treatments

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 Design
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Study Type : Observational
Actual Enrollment : 1204 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : May 2013
Actual Primary Completion Date : April 11, 2019
Actual Study Completion Date : April 11, 2019
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855412


Locations
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Sponsors and Collaborators
Cardiovascular Systems Inc
Investigators
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Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by Cardiovascular Systems Inc:
Study Protocol  [PDF] August 21, 2014
Statistical Analysis Plan  [PDF] March 24, 2018

More Information
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Publications of Results:
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 May 13 (Ahead of Issue).

Other Publications:

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Responsible Party: Cardiovascular Systems Inc
ClinicalTrials.gov Identifier: NCT01855412    
Other Study ID Numbers: CLN-0001-P
First Posted: May 16, 2013    Key Record Dates
Results First Posted: May 18, 2021
Last Update Posted: June 25, 2021
Last Verified: June 2021
Keywords provided by Cardiovascular Systems Inc:
PAD
LIBERTY
Observational
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases