Clinical Research Directory

Inclusion Criteria: * Patient is ≥18 and ≤85 years of age * The target AV fistula has undergone successful dialysis for at least 1 time * Patient has a de novo and/or non-stented restenotic lesion located in the outflow vein（Arteries and Central Vein are excluded） * Patient has a de novo and/or non-stented restenotic lesion（≥50% stenosis）and at least one of the following occurs： * The physical examination was abnormal * Significant increase in dynamic venous pressure * Blood flow decreased significantly * Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length * Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a PTA balloon defined as: * Residual stenosis of ≤ 30% AND * Absence of a flow limiting dissection (Grade ≥C) or perforation * Patient provides written informed consent prior to enrollment in the study Exclusion Criteria: * Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children * Dialysis access is located in the lower extremity * More than one lesion * Patient with hemodynamically significant central venous stenoses * Patient has presence of a stent located in the target AV access circuit * Patient has undergone prior intervention of access site within 30 days of index procedure * Patient with target AVF or access circuit which previously had or currently has a plan to surgery * Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy * Patients undergoing immunotherapy or suspected/confirmed vasculitis * Patients with a history of coagulation dysfunction, thrombocytopenic purpura or RH-negative blood type * Patient has an infected AV access or systemic infection * Patient has a life expectancy of \<24 months * Patient is anticipating a kidney transplant or with anticipated conversion to peritoneal dialysis * Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation * Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study