Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae

Exclusion Criteria

• •1. Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception.
• •2. Previous participation in another study with any investigational drug or device within the past 30 days.
• •3. Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult.
• •4. Known hypersensitivity to paclitaxel or structurally-related compounds.
• •5. Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
• •6. Stenosis with corresponding thrombosis treated within 7 days before enrollment.
• •7. Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
• •8. Infected grafts/fistulae.