NCT03566927终止不适用
FLEX®-DCB Dialysis ACCESS Stenosis Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Target Lesion Primary Patency
研究概览
简要总结
This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the informed consent form.
- •Arteriovenous fistula is located in the arm.
- •Native AV fistula / graft was created ≥ 30 days prior to the initial procedure and has undergone at least one hemodialysis sessions.
- •Venous stenosis of the AV fistula / graft with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.
- •Patients with a dysfunctional or thrombosed hemodialysis access and a >50% stenosis, regardless of prior treatment (All types of lesion and access failure)
- •If AV access is thrombosed, must undergo a successful thrombectomy with minimal residual thrombus.
- •Intended target lesion or if a tandem lesion can be treated with ≤120 mm of DCBs in length.
排除标准
- •Life expectancy < 9 months
- •Women who are pregnant, lactating, or planning on becoming pregnant during the duration of the study.
- •The hemodialysis access is located in the leg.
- •Patient has more than two lesions in the access circuit.
- •Patient has a secondary non-target lesion that cannot be successfully treated
- •Target lesion is located central to the axillosubclavian junction.
- •Surgical revision of the access site planned.
- •Recent surgical interventions of the access site.
- •Known allergy or sensitivity to iodinated contrast media, that cannot be adequately managed with pre- and post-procedure medication.
- •Known allergy or sensitivity to paclitaxel.
- •Patients who are taking immunosuppressive therapy, or routinely taking ≥ 10 mg of prednisone per day.
- •Patients who have a medical condition, in the opinion of the Investigator, that may cause the patient to be noncompliant to the protocol or confound the data.
- •Patients anticipating a kidney transplant.
- •Patients anticipating a conversion to peritoneal dialysis.
- •The patient has a stent located in the target or secondary non-target lesion.
- •Patient has an active infection in the AV access or a systemic infection.
- •Known hyper-coagulable state
- •Currently participating in an investigational drug, biologic, or device study.
- •Previously enrolled in this study.
结局指标
主要结局
Target Lesion Primary Patency
时间窗: 9 Months
Target Lesion Primary Patency at 9 months defined as the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.
次要结局
- Percentage of Patients with Freedom from Adverse Events(1 Month)
- Assess Secondary Patency(3, 6, 9 Months)
- Index of Patency Function(3, 6, 9 Months)
- Number of Interventions(9 Months)
研究者
研究点 (2)
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