A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon for the Treatment of the Obstructive Lesions in the Native Arteriovenous Dialysis Fistuae(AVF)
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).
• 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