ACOART AVF RENEW: A Post Market Clinical Study

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 outflowvein（Arteries and Central Vein are excluded）
• Patient has a de novo and/or non-stented restenotic lesion（≥50% stenosis）and at leastone 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 andpre-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 menintending 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 indexprocedure
• Patient with target AVF or access circuit which previously had or currently has a planto 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 orRH-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 toperitoneal dialysis
• Patient has a co-morbid condition that, in the judgment of the Investigator, may causehim/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 hasnot completed the primary endpoint, or was previously enrolled in this study