FLEX®-DCB Dialysis ACCESS Stenosis Study

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.