NCT05757726已完成不适用
Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
Venova Medical1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Major Reintervention
研究概览
简要总结
An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring hemodialysis vascular access.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 or older
- •Diagnosed with ESRD and currently on hemodialysis for less than 12 months using a central venous catheter for access
- •Eligible for a native surgical brachiocephalic arteriovenous fistula following assessment by the principal investigator and study sponsor
- •Cubital perforating vein diameter of > 2.5 mm and length > 10.0 mm
- •Proximal radial artery diameter ≥ 2.0 mm
- •Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure
- •Willing and competent to give written informed consent
排除标准
- •Distance between Proximal Radial Artery and Cubital Perforating vein > 3mm
- •Ipsilateral arm systolic blood pressure < 110 mmHg
- •Known central venous stenosis or central vein narrowing > 50% ipsilateral to the study extremity
- •Any obstruction of venous outflow from device implant site to the axillary vein
- •Patients with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
- •Any previous dialysis vascular access procedures in the study extremity
- •History of steal syndrome (hand ischemia) from a previous hemodialysis vascular access of the non-study extremity which required intervention or access abandonment
- •Upper extremity venous occlusion(s) and/or vessel abnormality(ies) of the study extremity that precludes endovascular AVF creation as determined by principal investigator or study sponsor
- •Evidence of active systemic infections on day of the procedure or infection at the access site within the past 7 days
- •History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- •Currently being treated with another investigational device or drug
- •Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
- •Uncontrolled or poorly controlled diabetes defined as a HbA1C > 10%
- •Hypercoagulable condition, bleeding diathesis or coagulation disorder
- •Receiving anti-coagulant therapy that cannot be safely held in the peri-procedural period
- •Edema of the upper arm of the study extremity
- •Scheduled kidney transplant within 6 months of enrollment
- •Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3
- •Current diagnosis of carcinoma (defined as in remission < 1 year)
- •Pregnant or currently breast feeding
- •History of substance abuse or anticipated to be non- compliant with medical care or study requirements based on investigator judgment
- •Allergies to NiTi alloy or any of the components of the Velocity Implant or Delivery System
- •Written informed consent not obtainable
结局指标
主要结局
Major Reintervention
时间窗: 6 weeks
Defined as any open surgery, thrombectomy or thrombolysis in the index limb following pAVF creation.
Procedural Success
时间窗: Immediate
Defined as Velocity deployment and delivery system withdrawal with intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein 2 cm central from the pAVF anastomosis
Serious Adverse Device Events
时间窗: 6 weeks
Defined as any Serious Adverse Event that reasonably suggests is caused by the device or procedure.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular AccessNCT06712251Venova Medical20
招募中
不适用
Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening IschemiaCritical Limb-Threatening IschemiaPeripheral Arterial DiseaseDiabetic FootNCT06277362EndoCore Lab s.r.l.50
已完成
1 期
Safety/Feasibility of Vonapanitase Following Angioplasty for Patients With Peripheral Artery Disease (PAD) Below the Knee (BTK)Peripheral Artery DiseaseNCT02956993Proteon Therapeutics29
撤回
1 期
Safety/ Feasibility of Percutaneous Administration of Vonapanitase as Monotherapy for Peripheral Artery Disease (PAD) of the SFA and Popliteal ArteriesPeripheral Artery DiseaseNCT02953496Proteon Therapeutics
招募中
不适用
Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose SensorDiabetes MellitusNCT06764069Glucotrack10