NCT03828253Unknown不适用
Ellipsys Percutaneous Arteriovenous Fistula for Hemodialysis Access
Richmond Vascular Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年8月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Blood flow Volume
研究概览
简要总结
To report the outcomes of patients having percutaneous proximal radial artery fistula creation.
详细描述
The study would like to enroll up to 100 patients without age, gender-based, race and ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing potential are not excluded. If a pregnant patient required, an arteriovenous fistula for hemodialysis an Ellipsys® fistula would be an option. The Investigator would like to consent previous Ellipsys® patients with appropriate medical records so that the Investigator may capture participants data for outcomes reporting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient age > 18 years or older
- •Diagnosed with ESRD or chronic kidney disease requiring dialysis or anticipating start of dialysis
- •Adjacent vein diameter of > 2.0 mm at target anastomosis site and confirmed clinically significant outflow
- •Arterial lumen diameter of > 2.0 mm at target anastomosis site
- •Adequate collateral arterial perfusion: Barbeau test grade A through C
- •Radial artery -adjacent vein proximity < 1.5 mm measured lumen edge-to-lumen edge via ultrasound
排除标准
- •Target vessel that are < 2mm is diameter
- •Distance between the target artery and vein > 1.5 mm
- •Edema of the upper extremity on the ipsilateral side
- •Barbeau test grade D
结局指标
主要结局
Blood flow Volume
时间窗: 90 days
Brachial Artery flow volume of 500ml as measured on Ultrasound Duplex
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Prospective Registry on Vascular Access in Interventions in Lazio RegionPostoperative HemorrhagesNCT00674778San Filippo Neri General Hospital1,052
招募中
3 期
Arteriovenous fistula anastomosis in patients with chronic renal failureChronic renal failure.Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal diseaseI13.11IRCT20190717044255N6Arak University of Medical Sciences72
已完成
不适用
Distal Radial Access for Primary PCI in STEMI Patients to Prevent RAOST Segment Elevation Myocardial InfarctionNCT05461781Beijing Luhe Hospital512
Unknown
3 期
Efficacy and success rate of distal radial artery access at the anatomical snuffbox for coronary intervention at Central Chest Institute of ThailandThe study was efficacy and success rate of distal radial artery access at the anatomical snuffbox for coronary interventionanatomical snuffbox, transradial cathterizationTCTR20220929001Central chest institute of Thailand115
已完成
不适用
Increasing Security With End-zone Arterial Blood Pressure Monitoring During SurgeryCatheterization, PeripheralNCT06033677Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital101