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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 328
- 试验地点
- 33
- 主要终点
- Target Lesion Primary Patency (TLPP) at 6 months post-procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Target Lesion Primary Patency (TLPP) at 6 months post-procedure
时间窗: 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.
次要结局
- Clinically-driven Target Lesion Revascularization (CD-TLR)(1, 6, 12, 18, and 24 months post-procedure)
- Device Success(During the procedure)
- Technical Success(0-5 days post-procedure)
- Clinical Success(0-5 days post-procedure)
- Target Lesion Primary Patency (TLPP)(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(6, 12, 24 months post-procedure)
- Clinically-driven Target Shunt Revascularization (CD-TSR)(1, 6, 12, 18, and 24 months post-procedure)