NCT06205576招募中不适用
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)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Target Lesion Primary Patency Rate
研究概览
简要总结
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).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
- •Dialysis access is located in the lower extremity
- •More than one lesion
- •Patient with hemodynamically significant central venous stenoses
- •Patient has presence of a stent located in the target AV access circuit
- •Patient has undergone prior intervention of access site within 30 days of index procedure
- •Patient with target AVF or access circuit which previously had or currently has a plan to surgery
- •Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
- •Patients undergoing immunotherapy or suspected/confirmed vasculitis
- •Patients with a history of coagulation dysfunction, thrombocytopenic purpura or RH-negative blood type
- •Patient has an infected AV access or systemic infection
- •Patient has a life expectancy of <24 months
- •Patient is anticipating a kidney transplant or with anticipated conversion to peritoneal dialysis
- •Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation
- •Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study
研究组 & 干预措施
DCB catheter
Experimental
Using DCB catheter for the treatment of subjects with a de novo or non-stented restenotic obstructive lesion located in the native arteriovenous dialysis fistulae.
干预措施: DCB catheter (Device)
结局指标
主要结局
Target Lesion Primary Patency Rate
时间窗: 6 months
Defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured.
Serious Adverse Event Rate
时间窗: 30 days
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit.
次要结局
- Target Lesion Primary Patency Rate(12 months，24 months)
- All-cause mortality Rate(24 months)
研究者
研究点 (1)
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