jRCT2032240406招募中不适用
A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis (RANGER AV Japan study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 主要终点
- target lesion primary patency (TLPP) rate at 6 months post index procedure
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subject is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits.
- •Subject at least 18 years of age.
- •Subject has a native AV fistula created >= 60 days prior to enrollment.
- •The target AVF has undergone successful dialysis for at least 8 of 12 sessions during a four-week period prior to enrollment.
- •Subjects on stable dialysis has all of the following criteria meet.
- •No significant decrease in blood pressure during dialysis during a four-week period prior to enrollment
- •No significant edema
- •No signs of heart failure
- •Target lesion is located between the arteriovenous anastomosis and axillosubclavian junction.
- •Note: If the lesion is in the anastomosis, the treatment may be delivered up to 2 cm upstream on the arterial side. Note: If the lesion is in the cephalic arch, the treatment may be delivered up to 2 cm into the subclavian vein.
- •Angiographic evidence that target lesion consists of a de novo and/or non-stented restenotic lesion with >= 50% stenosis by visual estimate.
- •Most recent standard PTA (ie. non-drug coated) treatment must be > 3 months prior to enrollment and most recent DCB treatment must be > 6 months prior to enrollment.
- •A target lesion with total lesion length up to 130 mm by visual estimate. Note: Tandem (or adjacent) lesions may be enrolled provided they meet all of the following criteria:
- •a. Separated by a gap of <= 30mm (3 cm).
- •b. Total combined lesion length, including 30 mm gap, is <= 130 mm.
- •c. Able to be treated as a single lesion.
- •Reference vessel diameter >= 4.0 mm and <= 8.0 mm by visual estimate.
- •Subject underwent successful crossing of the target lesion with the guide wire and pre-dilatation with only high pressure PTA balloon(s) defined as:
- •a. Residual stenosis of <= 30% AND.
- •b. Absence of a flow limiting dissection (Grade >= C) or perforation.
排除标准
- •Life expectancy, documented in the investigators opinion, of less than 12 months.
- •Receiving immunosuppressive therapy.
- •Anticipating a kidney transplant within 6 months of enrollment into the study.
- •Patient with anticipated conversion to peritoneal dialysis.
- •Patient with AVF infection or systemic infection.
- •Patient has planned surgical revision of AVF.
- •Presence of secondary non-target lesion requiring treatment within 30-days post index procedure.
- •Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion.
- •Patient with target AVF or access circuit which had within 1 year prior to enrollment or currently has a thrombosis.
- •Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.
- •Target lesion located central to the axillosubclavian junction.
- •Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AVF.
- •Presence of aneurysm requiring treatment at the lesion site.
- •Presence of a stent or graft located in the target access circuit.
- •Known allergies or sensitivities to paclitaxel and/or raw materials of test devices including ATBC (refer to Kiki-gaiyosho).
- •Known contraindication, including allergic reaction, or sensitivity to contrast material that, in the opinion of the investigator, cannot be adequately pretreated.
- •Patient who cannot receive antiplatelet and/or anticoagulant therapy in accordance with the investigators direction.
- •Clinically significant Steal Syndrome requiring treatment.
- •Women who are breastfeeding, pregnant, or the subject with known intention to procreate within 6 months after index procedure. Note: 6-month contraception after index procedure is required.
- •Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint, or subject was previously enrolled in this study.
- •Subject intends to participate in another investigational drug or device clinical trial within 6 months after the index procedure.
- •Patient has a co-morbid condition that, in the opinion of the investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation.
结局指标
主要结局
target lesion primary patency (TLPP) rate at 6 months post index procedure
时间窗: 6 months post index procedure
Primary patency is a binary endpoint, defined as freedom from clinically-driven target lesion revascularization (clinically-driven TLR) or access circuit thrombosis measured at 6 months post index procedure. Note: Clinically-driven TLR is defined as any re-intervention involving the target lesion in which: - The subject has a >=50% diameter stenosis (per angiographic core laboratory assessment) in the presence of clinical or physiologic abnormalities that indicate dialysis access dysfunction OR - >=70% stenosis (per angiographic core laboratory assessment) without the presence of clinical or physiologic abnormalities indicating dialysis access dysfunction
次要结局
未报告次要终点
研究者
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