A Prospective, Global, Multicenter, Single Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix® Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 213
- 试验地点
- 26
- 主要终点
- Percentage of Participants With Target Lesion Primary Patency (TLPP)
研究概览
简要总结
This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.
详细描述
This post-market approval study (PAS) is required by the FDA as a condition of approval for the Lutonix drug coated balloon catheter. It is intended to demonstrate safety and assess the clinical use and outcomes of the LUTONIX Catheter in dysfunctional arteriovenous fistulae (AVF) in a heterogeneous patient population in real world clinical practice.
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
- •Male or non-pregnant, non-breastfeeding female ≥18 years of age
- •Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits
- •Target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines
- •Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU)
- •Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein
- •Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as:
- •No clinically significant dissection;
- •No extravasation requiring treatment;
- •Residual stenosis ≤30% by angiographic measurement;
- •Ability to completely efface the waist using the pre-dilation balloon.
排除标准
- •Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study
- •Subject has a non-controllable allergy to contrast
- •Subject has another medical condition that, in the opinion of the Investigator, may confound the data interpretation or is associated with a life expectancy insufficient to allow for completion of subject study procedure and follow up
- •Target lesion is located central to the axillosubclavian junction
- •A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure
- •Prior surgical interventions of the access site ≤30 days before the index procedure
- •Target lesion is located within a bare metal or covered stent
研究组 & 干预措施
LUTONIX 035 Drug Coated Balloon PTA Catheter
This is a single-arm study. All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
干预措施: LUTONIX 035 Drug Coated Balloon PTA Catheter (Device)
结局指标
主要结局
Percentage of Participants With Target Lesion Primary Patency (TLPP)
时间窗: 6 Months
TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.
Percentage of Participants With No Primary Safety Events
时间窗: 30 days
Primary safety events include any serious adverse event(s) involving the AV access circuit through 30 days
次要结局
- Number of re-interventions required to maintain access circuit patency(6, 12, 18, 24 Months)
- Percentage of Participants With Abandonment of Permanent Access in the Index Extremity(6, 12, 18, 24 Months)
- Percentage of Participants With Secondary Patency of the Access Circuit(6, 12, 18, 24 Months)
- Time to loss of target lesion secondary patency following DCB intervention(24 Months)
- Percentage of Participants With Freedom from any Serious Adverse Event(s) Involving the AV Access Circuit(6, 12, 18, 24 Months)
- Percentage of Participants With Target Lesion Primary Patency(12, 18, 24 Months)
- Number of re-interventions required to maintain target lesion patency(6, 12, 18, 24 Months)
- Percentage of Participants With Access Circuit Primary Patency (ACPP)(6, 12, 18, 24 Months)
- Percentage of Participants With Device, Procedural, and Clinical Success(24 Months)
- Percentage of Participants With Device and Procedure Related Adverse Events(6, 12, 18, 24 Months)