FLEX®-DCB Dialysis ACCESS Stenosis Study

Study Overview
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Brief Summary
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This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.

Official Title
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FLEX®-DCB Dialysis ACCESS Stenosis Study

Conditions
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Arteriovenous Fistula

Intervention / Treatment
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* Combination Product: FLEX Scoring Catheter with Lutonix DCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the informed consent form. Arteriovenous fistula is located in the arm. Native AV fistula / graft was created ≥ 30 days prior to the initial procedure and has undergone at least one hemodialysis sessions. Venous stenosis of the AV fistula / graft with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines. Patients with a dysfunctional or thrombosed hemodialysis access and a >50% stenosis, regardless of prior treatment (All types of lesion and access failure) If AV access is thrombosed, must undergo a successful thrombectomy with minimal residual thrombus. Intended target lesion or if a tandem lesion can be treated with ≤120 mm of DCBs in length. Exclusion Criteria: Life expectancy < 9 months Women who are pregnant, lactating, or planning on becoming pregnant during the duration of the study. The hemodialysis access is located in the leg. Patient has more than two lesions in the access circuit. Patient has a secondary non-target lesion that cannot be successfully treated Target lesion is located central to the axillosubclavian junction. Surgical revision of the access site planned. Recent surgical interventions of the access site. Known allergy or sensitivity to iodinated contrast media, that cannot be adequately managed with pre- and post-procedure medication. Known allergy or sensitivity to paclitaxel. Patients who are taking immunosuppressive therapy, or routinely taking ≥ 10 mg of prednisone per day. Patients who have a medical condition, in the opinion of the Investigator, that may cause the patient to be noncompliant to the protocol or confound the data. Patients anticipating a kidney transplant. Patients anticipating a conversion to peritoneal dialysis. The patient has a stent located in the target or secondary non-target lesion. Patient has an active infection in the AV access or a systemic infection. Known hyper-coagulable state Currently participating in an investigational drug, biologic, or device study. Previously enrolled in this study.

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: FLEX Scoring Catheter plus DCB<br>This is a single-arm study. All patients will be treated with the FLEX Scoring Catheter, then a standard balloon angioplasty, followed by a Lutonix® drug-coated balloon (DCB). | Combination Product: FLEX Scoring Catheter with Lutonix DCB<br>* Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Primary Patency | Target Lesion Primary Patency at 9 months defined as the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index of Patency Function | Index of Patency Function defined as the average time between interventions. | 3, 6, 9 Months | 
| Assess Secondary Patency | Assess Secondary Patency defined as the time interval from initial study treatment to abandonment of the vascular access circuit. | 3, 6, 9 Months | 
| Number of Interventions | Mean cumulative interventions per subjects over study duration. | 9 Months | 
| Percentage of Patients with Freedom from Adverse Events | Freedom from major device, procedure and treatment site-related adverse events through 30 days' post procedure. | 1 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arteriovenous Fistula, Vascular Fistula, Scoring, Fistula, Cardiovascular Disease