FLEX Arteriovenous Access Registry

Study Overview
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Brief Summary
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Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.

Official Title
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FLEX Arteriovenous Access Registry

Conditions
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Peripheral Artery Disease, Arteriovenous Fistula Stenosis, Arteriovenous Graft Stenosis

Intervention / Treatment
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* Device: FLEX Vessel Prep System followed by angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities. The patient is ≥18 years of age. Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the inform consent form. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. The patient understands the study and is willing and able to comply with follow-up requirements. The patient is willing to provide informed consent. Exclusion Criteria: The patient has a known or suspected systemic infection. The patient has a known or suspected infection of the hemodialysis graft. The patient has an untreatable allergy to radiographic contrast material. In the opinion of the operating physician, the patient's hemodialysis access is unsuitable for endovascular treatment.

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 |
| --- | --- |
| FLEX Vessel Prep followed by angioplasty<br> | Device: FLEX Vessel Prep System followed by angioplasty<br>* Eligible Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) will be treated with the FLEX Vessel Prep system followed by angioplasty.<br>* Other names: Balloon Angioplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomic Success | Defined as the angiographic percentage of stenosis post procedure as <30% | At the completion of the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success of the Device | Delivery to the target lesion, deployment of the treatment element, and retrieval | At the index procedure | 
| Clinical Success | The resumption of normal dialysis for at least one session. | 6 Months | 
| Procedural Success | Composite of anatomic and clinical success | 6 Months | 
| Target Lesion Primary Patency | The time interval of uninterrupted patency from initial study treatment to the next thrombosis or intervention performed on the target lesion | 6, 9 and 12 Months | 
| Circuit Primary Patency | The time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit. | 6, 9, and Months | 
| Assisted Primary Patency | The time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. | 6, 9, and 12 Months | 
| Access Secondary Patency | The time interval from initial study treatment to abandonment of the vascular access circuit. | 6, 9, and 12 Months |