This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis.
Age ≥ 18 and ≤ 80 years old;
The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;
The target lesion is located at the AVF/AVG return vein and venous side anastomosis;
Hemodynamically significant AVF/AVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical symptoms, signs or indicators are present, including significant increase in venous pressure during dialysis, abnormal physical examination, decreased pump-controlled blood flow, decreased adequacy of dialysis, brachial artery blood flow < 600 ml/min or decreased by 25% compared with the previous follow-up visit, etc.;
Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;
Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
Calcified lesions that are not expected to be expandable with balloons;
Patients with thrombosis at the access stenosis site;
Single group
Dissolve AV Peripheral Scoring Drug-coated Balloon
DeviceSubjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon
Target Lesion Primary Patency (TLPP) at 6 months post-procedure
Target Lesion Primary Patency is defined as freedom from clinically driven Target Lesion Failure (TLF) (including +/-5mm proximal or distal of the target lesion) or Vascular Access Thrombosis. TLF is defined as the presence of at least one clinical symptom, sign or indicator (defined according to the NKF-K/DOQI guideline) due to target lesion stenosis (≥ 50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including a significant increase in venous pressure during dialysis, high blood pressure, abnormal physical examination, decreased pump-controlled blood flow, decreased dialysis adequacy, brachial artery blood flow \< 600 ml/min or decreased by 25% compared with the previous follow-up, etc.
Target Lesion Primary Patency (TLPP)
TLF is defined as the presence of at least one clinical symptom, sign or indicator (defined according to the NKF-K/DOQI guideline) due to target lesion stenosis (≥ 50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including a significant increase in venous pressure during dialysis, high blood pressure, abnormal physical examination, decreased pump-controlled blood flow, decreased dialysis adequacy, brachial artery blood flow \< 600 ml/min or decreased by 25% compared with the previous follow-up, etc.
Proportion of patients whose peak systolic flow velocity ratio (PSVR) ≤ 2.0, as determined by Doppler ultrasound (DUS), so as to confirm the absence of restenosis
Proportion of patients whose peak systolic flow velocity ratio (PSVR) ≤ 2.0, as determined by Doppler ultrasound (DUS), at 6, 12, and 24 months post-procedure, so as to confirm the absence of restenosis.
Clinically-driven Target Lesion Revascularization (CD-TLR)
Any reintervention of a target lesion (including +/-5 mm proximal or distal to the target lesion) as determined by clinical symptoms or dialysis indicators indicating that it is unable to perform dialysis.
Clinically-driven Target Shunt Revascularization (CD-TSR)
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