Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae

Study Overview
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Brief Summary
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This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Detailed Description
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This post-market approval study (PAS) is required by the FDA as a condition of approval for the Lutonix drug coated balloon catheter. It is intended to demonstrate safety and assess the clinical use and outcomes of the LUTONIX Catheter in dysfunctional arteriovenous fistulae (AVF) in a heterogeneous patient population in real world clinical practice.

Official Title
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A Prospective, Global, Multicenter, Single Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix® Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae

Conditions
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Arteriovenous Fistula

Intervention / Treatment
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* Device: LUTONIX 035 Drug Coated Balloon PTA Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant, non-breastfeeding female ≥18 years of age Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits Target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU) Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as: No clinically significant dissection; No extravasation requiring treatment; Residual stenosis ≤30% by angiographic measurement; Ability to completely efface the waist using the pre-dilation balloon. Exclusion Criteria: Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study Subject has a non-controllable allergy to contrast Subject has another medical condition that, in the opinion of the Investigator, may confound the data interpretation or is associated with a life expectancy insufficient to allow for completion of subject study procedure and follow up Target lesion is located central to the axillosubclavian junction A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure Prior surgical interventions of the access site ≤30 days before the index procedure Target lesion is located within a bare metal or covered stent

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LUTONIX 035 Drug Coated Balloon PTA Catheter<br>This is a single-arm study. All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter. | Device: LUTONIX 035 Drug Coated Balloon PTA Catheter<br>* All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Target Lesion Primary Patency (TLPP) | TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. | 6 Months | 
| Percentage of Participants With No Primary Safety Events | Primary safety events include any serious adverse event(s) involving the AV access circuit through 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Target Lesion Primary Patency | TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. | 12, 18, 24 Months | 
| Number of re-interventions required to maintain target lesion patency | Clinically driven reintervention is defined as a lesion that has ≥ 50% stenosis and at least one clinical, physiological or hemodynamic abnormality attributable to the stenosis defined in the K/DOQI guidelines. | 6, 12, 18, 24 Months | 
| Percentage of Participants With Access Circuit Primary Patency (ACPP) | Access circuit is defined as the area from the AV access anastomosis to the superior vena cava-right atrial junction. | 6, 12, 18, 24 Months | 
| Number of re-interventions required to maintain access circuit patency | Clinically driven reintervention is defined as a lesion that has ≥ 50% stenosis and at least one clinical, physiological or hemodynamic abnormality attributable to the stenosis defined in the K/DOQI guidelines. | 6, 12, 18, 24 Months | 
| Percentage of Participants With Device, Procedural, and Clinical Success | Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure. Procedural Success: At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs). Clinical Success: The resumption of dialysis for at least one session after the index procedure. | 24 Months | 
| Percentage of Participants With Abandonment of Permanent Access in the Index Extremity | The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning. | 6, 12, 18, 24 Months | 
| Percentage of Participants With Secondary Patency of the Access Circuit | Survival of patency of access circuit from the time of intervention until access abandonment or achievement of a censored event (death, transfer to another hemodialysis unit, transfer to peritoneal dialysis, transplantation, and end of study period), and includes all surgical and endovascular interventions. | 6, 12, 18, 24 Months | 
| Time to loss of target lesion secondary patency following DCB intervention | Time between first reintervention with the DCB to the next loss of patency | 24 Months | 
| Percentage of Participants With Freedom from any Serious Adverse Event(s) Involving the AV Access Circuit | Safety events include any serious adverse event(s) involving the AV access circuit | 6, 12, 18, 24 Months | 
| Percentage of Participants With Device and Procedure Related Adverse Events | Freedom from device-related or procedure-related serious adverse events | 6, 12, 18, 24 Months |