Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon

Study Overview
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Brief Summary
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The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical application.

Detailed Description
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The registry is a prospective, multi-center, single-arm, real-world study to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, anterior tibial and peroneal arteries). Follow-up for all treated subjects will be performed at hospital discharge, 30 days, and 6 and 12 months post-index procedure.

Official Title
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A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon

Conditions
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Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases

Intervention / Treatment
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* Device: PTA (UltraScore Focused Force PTA Balloon)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures. Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures. Subject must be willing to comply with the protocol requirements, including the follow-up procedures. Subject must have a target lesion (de novo lesion or prior failed treatment) that can be treated with the UltraScore™ Focused Force PTA balloon according to the Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may be treated for this study. Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off. The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed). Exclusion Criteria: Subjects that are to receive one or more stents as adjunctive therapy at the target lesion (bail out stenting is allowed). The subject has a single target lesion that involves both ATK and BTK arteries. The subject has a target lesion in a previously placed stent or stent graft (in-stent restenosis). The subject has a lesion, which in the opinion of the Investigator, would preclude safe use of the UltraScore™ Focused Force PTA balloon. The subject has a flow limiting dissection at the target lesion prior to use of the UltraScore™ Focused Force PTA balloon. The subject has acute limb ischemia. The subject has been assessed Rutherford category 6. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated. The subject has another medical condition or is currently participating in an investigational drug or another device study that, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.

Ages Eligible for Study
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Minimum Age: 21 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 |
| --- | --- |
| PTA-UltraScore Focused Force PTA balloon<br>Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU. | Device: PTA (UltraScore Focused Force PTA Balloon)<br>* Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough. The UltraScore Focused Force PTA balloon through the blood vessel to the narrowed area to be treated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieve optimal PTA results | Optimal result is defined as ≤30% residual stenosis without major flow-limiting dissection, as measured by angiographic imaging. Major flow limiting dissections are classified by the National Heart, Lung, and Blood Institute (NHLBI) as Grade D (Spiral luminal filling defects), Grade E (Appearance of new and persistent filling defects with reduced flow), and Grade F (Total occlusion without distal flow). | Index procedure (Day 0); approximate duration of procedure is 90 minutes. | 
| Technical success of use of UltraScore™ Focused Force PTA balloon | Technical success is determined subjectively by the investigator according to delivery location of the study device relative to the target lesion, as assessed by angiographic imaging, and inflation without movement. | Index procedure (Day 0); approximate duration of procedure is 90 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of bail-out stenting due to dissection | Rate of emergency artery stent placement for abrupt or threatened artery closure caused by arterial dissection immediately following index procedure. | Index procedure (Day 0); approximate duration of procedure is 90 minutes. | 
| Freedom from target lesion revascularization (TLR). | TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure | 30 days, 6 months, and 12 months post-index procedure | 
| Freedom from major amputation of the target limb | Major amputation is defined as above the ankle amputation | 30 days, 6 months, and 12 months post-index procedure | 
| Improved clinical measures from baseline | Resting ankle brachial index (ABI) and Rutherford classification for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline. | 30 days, 6 months, and 12 months post-index procedure | 
| Primary patency for Above the Knee (ATK) subjects | ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency is measured by duplex ultrasound (DUS) core lab; a peak systolic velocity ratio (PSVR) ≥2.5 suggests 50% restenosis and loss of patency. | 30 days, 6 months, and 12 months post-index procedure |