Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Peripheral Arterial Occlusive Disease

Intervention / Treatment
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* Other: PAD endovascular treatments


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Claudication (Rutherford 2-3)<br>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<br>* All FDA-cleared endovascular PAD treatments<br>|
| CLI Rutherford 4-5<br>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<br>* All FDA-cleared endovascular PAD treatments<br>|
| CLI Rutherford 6<br>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<br>* All FDA-cleared endovascular PAD treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, LIBERTY, Observational