A Prospective, Single-Centre Study Investigating the Clinical Use and Safety of the Jetstream Atherectomy With Drug Coated Balloon (Ranger) for the Treatment of Dysfunctional Arterio-Venous Graft Stenosis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Target Lesion Primary Patency (TLPP) through 6 months
研究概览
简要总结
This single-centre, single-arm, prospective study will enroll 30 subjects presenting with clinical and hemodynamic abnormalities in arteriovenous graft (AVG) in the arm. Subjects will be treated with the Jetstream™ atherectomy device and Ranger™ Drug Coated Balloons (DCB). Subjects will be followed up clinically via office visit or phone visit at 6 and 12 months post procedure. This study is to demonstrate safety and assess the clinical use and outcomes of the Jetstream ™atherectomy device and Ranger™ DCB for the treatment of dysfunctional AV graft.
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 graft presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines;
- •Subject has a target lesion at the venous anastomosis of the AVG;
- •Successful crossing of the stenosis;
- •Each lesion length is ≤20mm, which may include tandem lesions that are ≤20mm apart
排除标准
- •Subject is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this study;
- •Subject has a non-controllable allergy to contrast;
- •Subject has more than 3 lesions in the access circuit requiring intervention;
- •Target lesion diameter >10mm;
- •A thrombosed access or an access with a thrombosis treated ≤30 days prior 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
Dysfunction AV graft
Dysfunctional AV graft stenosis treated with atherectomy and drug coated balloon angioplasty
干预措施: Atherectomy and balloon angioplasty (Device)
结局指标
主要结局
Target Lesion Primary Patency (TLPP) through 6 months
时间窗: within 6 months post intervention
50% re-stenosis of the target lesion
次要结局
未报告次要终点