Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.

Official Title
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A Prospective, MultiCenter, Single-arm, Post-market Study of Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts (ACCESS)

Conditions
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Dysfunctional AV Graft, Dysfunctional AV Fistula

Intervention / Treatment
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* Device: Lutonix Paclitaxel Drug Coated Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF) Hemodialysis access on the arm presenting with any clinical abnormalities as defined in the K/DOQI guidelines Native AV fistula or synthetic AV graft has been implanted ≥30 days Target de novo or non-stented restenotic lesion(s) consisting of a >50% stenosis by visual estimate. Successful treatment of non target lesion(s) (residual stenosis <30% by visual estimate) without procedural complication by standard of care Successful predilatation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon Intended target lesion(s) (maximum of 2) can be treated No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the treatment Exclusion Criteria: Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children Known contraindication (including allergic reaction) or sensitivity to contrast media, ASA, clopidogrel, ticlopidine, paclitaxel (mild to severe cases), that cannot be adequately managed with pre-and post-procedure medication Life expectancy <12months Scheduled for kidney transplant or peritoneal dialysis in the next 12months; Thrombosed access Stent in the target treatment area Blood coagulative disorder, sepsis, or current AV access infection Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study NOTE: Enrollment in another investigational drug, biologic, or device study during the follow- up period is not allowed

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 |
| --- | --- |
| Experimental: Lutonix Paclitaxel Drug Coated Balloon<br> | Device: Lutonix Paclitaxel Drug Coated Balloon<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Primary Patency | Target Lesion Primary Patency (TLPP): The interval following index procedure intervention until the next reintervention of the target lesion or access thrombosis. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Primary Patency (TLPP) |  | 12 months | 
| Access circuit primary patency |  | 6 and 12 months | 
| Abandonment of permanent access in the index extremity |  | 6 and 12 months | 
| Number of interventions required to maintain target lesion patency |  | 6 and 12 months | 
| Number of interventions, required to maintain access circuit patency | The access circuit is defined as the area from the AV access graft arterial anastomosis to the superior vena-cava right atrial junction. The outcome is recording all interventions that occur in the access circuit up until the time of circuit failure (patency). | 6 and 12 months | 
| Major vascular complications |  | < or at 1 month | 
| Rate of device and procedure related adverse events |  | 1, 6 and 12 months |