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
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
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
- All-cause mortality Rate(24 months)
- Target Lesion Primary Patency Rate(12 months，24 months)
研究者
研究点 (1)
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