Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter

Study Overview
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Brief Summary
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The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.

Detailed Description
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The registry is a prospective, multicenter, single arm post-market real-world registry in the U.S. assessing the clinical use, safety and outcomes of the Lutonix 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects will be followed for up to three year's post-index procedure.

Official Title
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A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter in Arteries of the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) (SAFE-DCB U.S. Registry)

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

Intervention / Treatment
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* Device: PTA (Lutonix® 035 DCB Catheter)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site. The subject agrees to comply with the protocol-mandated follow-up procedures and visits. The subject is ≥ 21 years old. The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB Catheter according to IFU. Exclusion Criteria: The subject is unable or unwilling to provide informed consent. The subject is unable or unwilling to comply with the patient registry protocol follow-up procedures and visits. The subject has another medical condition or is currently participating in an investigational drug or an investigational device study that, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confounds the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of patient registry 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTA (Lutonix® 035 DCB Catheter)<br>Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU. | Device: PTA (Lutonix® 035 DCB Catheter)<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 Lutonix® DCB 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 |
| --- | --- | --- |
| Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure | TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure. | 12 months post-index procedure | 
| Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure | Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization. | 30 days post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure | TVR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, surgical bypass, etc.) in the target vessel after the index procedure (Kaplan-Meier estimates). | 6 , 12, 24, and 36 months | 
| Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure. | TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure (Kapln-Meier estimates). | 6, 24, and 36 months post index procedure | 
| Percentage of Participants With Acute Device and Procedural Success | Lesion success defined as attainment of < 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation) and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge. | At time of Index Procedure | 
| Percentage of Participants With Primary Patency at 12 Months Post Index Procedure | The absence of target lesion restenosis (defined by Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.5) and freedom from Target Lesion Revascularization (TLR). Primary Patency at 12-Months post index-procedure by Kaplan-Meier estimates using a Method in which all subjects without a confirmed TLR or loss of patency were censored at Day 395 or the date of study discontinuation, whichever occurred first. | 12 months post-index procedure | 
| Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure | Freedom from composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death (Kaplan-Meier estimates). | 6, 12, 24, and 36 Months Post Index Procedure | 
| Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure. | Freedom from major amputation of the target limb defined as above the ankle amputation | 6, 12, 24, and 36 Months Post Index Procedure |