Trial Parameters
Brief Summary
The objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).
Eligibility Criteria
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 int