A Prospective, Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Tri-wire Balloon Dilatation Catheter for the Treatment of Dysfunctional AV Fistula
试验速览
- 阶段
- 不适用
- 入组人数
- 168
- 试验地点
- 7
- 主要终点
- Technical Success
研究概览
简要总结
This prospective, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Tri-wire Peripheral Balloon Dilatation Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years;
- •Able to understand the purpose of the study, willing to participate and sign the informed consent, able and willing to accept the follow-up;
- •Indications of percutaneous transluminal angioplasty for target lesion: target lesion shows >50% narrowing relative to adjacent normal vein diameter by angiography or ultrasound with one of the indicators listed in KDOQI vascular access guideline 2019 update Table 13.
- •Reference vessel diameter of target lesion from 3.0 mm to 8.0 mm.
- •Target lesion located from proximal to the anastomosis to the reflux vein at the distal end of the subclavian vein.
- •De novo or restenosis lesion.
- •Single or tandem lesion, length of which ≤ 60mm.
排除标准
- •Women who are pregnant, nursing, or planning to become pregnant during the study.
- •Patients who have accepted major surgeries within 30 days prior to the enrollment. (such as thoracic surgery, cranial surgery).
- •Patients who plan to accept major surgeries within 30 days after the enrollment. (such as thoracic surgery, cranial surgery).
- •Occlusion lesion or thrombosis.
- •Infected fistula or severe systemic infection.
- •Patients who suffer from central venous diseases.
- •Patients known to be allergic or contraindicated to contrast agents.
- •Patients who have participated in another clinical trial within 3 months prior to the study, or previous enrollment in this study.
- •Subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol or confound the data interpretation.
研究组 & 干预措施
Experimental: Tri-wire Peripheral Balloon Dilatation Catheter
Percutaneous transluminal angiography (PTA) will be performed using the Tri-wire Peripheral Balloon Dilatation Catheter. Interventions: Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter; Procedure: Percutaneous Transluminal Angiography.
干预措施: Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter (Combination Product)
Active Comparator: OHICHO Ⅱ PTA Balloon Catheter.
Percutaneous transluminal angiography (PTA) will be performed using OHICHO Ⅱ PTA Balloon Catheter, a commercially available high-pressure PTA balloon. Multiple balloons, inflations and/or prolonged inflation may be used. Interventions: Device: OHICHO Ⅱ PTA Balloon Catheter. Procedure: Percutaneous Transluminal Angiography.
干预措施: Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter (Combination Product)
结局指标
主要结局
Technical Success
时间窗: Right after operation
The target lesion residual stenosis\<30%
次要结局
- Adverse Events(1 month)
- Device Success(Right after operation)
- Procedural Success(12-48 hours)
- Dilating Pressure(During the operation)
- Pain Score(Right after operation)
- Target Lesion Primary Patency (TLPP)(1 month)
- Target lesion restenosis(1 month)
- Fistula Blood Flow(1 month)