Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) for the treatment of obstructive lesions of Arteriovenous (AV) Dialysis Fistulae/Grafts.

Conditions
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Obstructive Lesions of Arteriovenous Dialysis Fistulae

Intervention / Treatment
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* Device: NMB Paclitaxel Drug Ejecting Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 years old or older. Native arteriovenous fistula or synthetic arteriovenous access graft performed/implanted more than 45 days before enrollment and at least one successful hemodialysis session performed. Patient having obstructive lesion of native or synthetic arteriovenous dialysis fistulae/grafts, suitable for PTA procedure. Patient who is willing and able to sign a written informed consent and that complies with procedures (including adherence to follow-up visits). Exclusion Criteria: Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception. Previous participation in another study with any investigational drug or device within the past 30 days. Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult. Known hypersensitivity to paclitaxel or structurally-related compounds. Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure. Stenosis with corresponding thrombosis treated within 7 days before enrollment. Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy. Infected grafts/fistulae.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>NMB's PTA Balloon catheter with Paclitaxel drug | Device: NMB Paclitaxel Drug Ejecting Balloon<br>* NMB's PTA Balloon catheter with drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis rate | Binary Stenosis is defined as ≥50% narrowing in luminal diameter basen upon comparison with the adjacent normal vessel. Restenosis Rate - comparison shall be performed both to the patient previous data as well as to restenosis rate data published in the literature for standard PTA balloon catheter procedure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| restenosis rate | As defined above in the primary end point | 1, 3 and 12 months | 
| Easy insertion and removal |  | intraprocedural | 
| Major adverse events rate | All adverse events will be reviewed by the Investigator and evaluated as follows: Nature of the event. Severity of the event - serious, moderate, mild. Relation of the adverse event to the device - unrelated, possible, definite | intraprocedural 1, 3, 6 and 12 months |