NCT02440022已完成3 期
A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing Lutonix® 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae
C. R. Bard46 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2015年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 285
- 试验地点
- 46
- 主要终点
- Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure
研究概览
简要总结
This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA 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
- Single (Participant)
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
- •Age ≥21 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);
- •Arteriovenous fistula located in the arm;
- •Native AV fistula was created ≥30 days prior to the index procedure and has undergone one or more hemodialysis sessions;
- •Venous stenosis of an AV fistula 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.;
- •Successful pre-dilation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon;
- •Intended target lesion.
排除标准
- •Women who are pregnant, lactating, or planning on becoming pregnant during the study;
- •Hemodialysis access is located in the leg;
- •Subject has more than two lesions in the access circuit;
- •Subject has a secondary non-target lesion that cannot be successfully treated;
- •Target lesion is located central to the axillosubclavian junction;
- •The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction);
- •A thrombosed access;
- •Surgical revision of the access site planned;
- •Recent prior surgical interventions of the access site;
- •Other planned treatment during the index procedure;
- •Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication;
- •Known contraindication (including allergic reaction) or sensitivity to paclitaxel.
- •Subjects who are taking immunosuppressive therapy or are routinely taking
- •≥10mg of prednisone per day;
- •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;
- •Subject has a life expectancy <12 months;
- •Anticipated for a kidney transplant;
- •Anticipated conversion to peritoneal dialysis;
- •Subject has a stent located in the target or secondary non target lesion;
- •Subject has an infected AV access or systemic infection;
- •Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study.
结局指标
主要结局
Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure
时间窗: 6 months post index procedure
Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.
Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure.
时间窗: 30 Days Post Index Procedure
The primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days that reasonably suggests the involvement of the AV access circuit (CEC adjudicated).
次要结局
- Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure(3, 6, 9, 12, 18 and 24 Months Post Index Procedure)
- Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated)(1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure)
- Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure(6 Months Post Index Procedure)
- Percentage of Participants With Device, Procedural and Clinical Success(Device and Procedural Success: At time of Index Procedure; Clinical Success: at 1st session of dialysis following index procedure)
- Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure(1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure)
- Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months(3, 9, 12, 18, and 24 Months Post Index Procedure)
- Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure(3, 6, 9, 12, 18 and 24 Months Post Index Procedure)
- Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure(3, 6, 9, 12, 18, and 24 Months Post Index Procedure)
研究者
研究点 (46)
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