Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

Official title

A Prospective, Multicenter, Single-Arm Target Value Clinical Study to Evaluate the Safety and Effectiveness of Peripheral Scoring Drug-coated Balloon Dilation Catheter in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

Overview

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.

Detailed description

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 (SDCB) in the treatment of hemodialysis arteriovenous fistula stenosis. A total of 328 participants will be enrolled across multiple clinical trial sites. Participants will undergo a surgical procedure using a peripheral scoring drug-coated balloon dilation catheter, with follow-up within 5 days, at 1 month, and 6 months after the procedure, then at 12, 18, and 24 months post-procedure. The target lesion primary patency (TLPP) at 6 months post-procedure is the defined primary endpoint to evaluate the safety and effectiveness of the peripheral scoring drug balloon dilatation catheter.

Interventions

• Device Dissolve AV Peripheral Scoring Drug-coated Balloon
  Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon

Primary outcome measures

• Target Lesion Primary Patency (TLPP) at 6 months post-procedure [Time frame: 6 months post-procedure]

Secondary outcome measures (7)

• Target Lesion Primary Patency (TLPP) [Time frame: 12, 24 months post-procedure]
• 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 [Time frame: 6, 12, 24 months post-procedure]
• Clinically-driven Target Lesion Revascularization (CD-TLR) [Time frame: 1, 6, 12, 18, and 24 months post-procedure]
• Clinically-driven Target Shunt Revascularization (CD-TSR) [Time frame: 1, 6, 12, 18, and 24 months post-procedure]
• Device Success [Time frame: During the procedure]
• Technical Success [Time frame: 0-5 days post-procedure]
• Clinical Success [Time frame: 0-5 days post-procedure]

Eligibility criteria

Inclusion criteria

• 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.;
• The target lesion is a primary or restenotic lesion, consisting of one or more tandem lesions (if the total length of adjacent tandem lesions is ≤ 60 mm, it can be considered a single target lesion);
• Visual inspection of the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤ 60mm;
• The patient voluntarily signs the informed consent form.

Exclusion criteria

• 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;
• The target lesion is located at the blood supply artery and arterial anastomosis;
• Patients known to be allergic to or intolerant to contrast media and paclitaxel;
• The patient's life expectancy is less than 2 years;
• Patients with systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated small vessel vasculitis;
• Patients with kidney transplantation or those who planned to undergo kidney transplantation or switch to peritoneal dialysis;
• Vascular access infection or systemic active infection;
• Those who have participated in unfinished clinical trials of other drugs or devices;
• Patients with other medical conditions that the investigator believes are not suitable to participate in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 33 centers

• The Second Hospital of Anhui Medical University — Hefei
• Beijing Haidian Hospital — Beijing
• The First Affiliated Hospital of Chongqing Medical University — Chongqing
• Guangzhou First People's Hospital — Guanzhou
• Huizhou Central People's Hospital — Huizhou
• Peking University Shenzhen Hospital — Shenzhen
• The Eighth Affiliated Hospital, Sun Yat-sen University — Shenzhen
• Liuzhou Traditional Chinese Medical Hospital — Liuzhou
• … and 25 more centers

Identifiers

NCT: NCT06422845 · VP-P-24-012

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗