NCT02183194撤回不适用
A Prospective, MultiCenter, Single-arm, Post-market Study of Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts (ACCESS)
C. R. Bard4 个研究点 分布在 2 个国家开始时间: 2014年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Efficacy: Primary Patency
研究概览
简要总结
The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF)
- •Hemodialysis access on the arm presenting with any clinical abnormalities as defined in the K/DOQI guidelines
- •Native AV fistula or synthetic AV graft has been implanted ≥30 days
- •Target de novo or non-stented restenotic lesion(s) consisting of a >50% stenosis by visual estimate. Successful treatment of non target lesion(s) (residual stenosis <30% by visual estimate) without procedural complication by standard of care
- •Successful predilatation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon
- •Intended target lesion(s) (maximum of 2) can be treated
- •No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the treatment
排除标准
- •Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children
- •Known contraindication (including allergic reaction) or sensitivity to contrast media, ASA, clopidogrel, ticlopidine, paclitaxel (mild to severe cases), that cannot be adequately managed with pre-and post-procedure medication
- •Life expectancy <12months
- •Scheduled for kidney transplant or peritoneal dialysis in the next 12months;
- •Thrombosed access
- •Stent in the target treatment area
- •Blood coagulative disorder, sepsis, or current AV access infection
- •Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study NOTE: Enrollment in another investigational drug, biologic, or device study during the follow- up period is not allowed
研究组 & 干预措施
Lutonix Paclitaxel Drug Coated Balloon
Experimental
干预措施: Lutonix Paclitaxel Drug Coated Balloon (Device)
结局指标
主要结局
Efficacy: Primary Patency
时间窗: 6 months
Target Lesion Primary Patency (TLPP): The interval following index procedure intervention until the next reintervention of the target lesion or access thrombosis.
次要结局
- Number of interventions required to maintain target lesion patency(6 and 12 months)
- Target Lesion Primary Patency (TLPP)(12 months)
- Access circuit primary patency(6 and 12 months)
- Abandonment of permanent access in the index extremity(6 and 12 months)
- Number of interventions, required to maintain access circuit patency(6 and 12 months)
- Major vascular complications(< or at 1 month)
- Rate of device and procedure related adverse events(1, 6 and 12 months)
研究者
研究点 (4)
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