Observational Study to Evaluate PAD Tre… | Clinical Trial

Key information

Conditions

Peripheral Arterial Occlusive Disease Peripheral Arterial Occlusive Disease 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mercy Gilbert Medical Center, Gilbert, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

PAD endovascular treatments

Other

All FDA-cleared endovascular PAD treatments

Primary outcomes

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.
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.
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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study 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)

Acronym: LIBERTY

Important dates

Study start: 2013
Primary completion: 2019
Study completion: 2019
First posted: May 16, 2013
Registry last updated: Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed