A Study of the Effect of the ROX Percutaneous Arteriovenous Fistula System (ROX AC1) on Exercise Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Improvement in exercise capacity.
研究概览
简要总结
To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease that leads to irreversible changes in the lung structure, but also to systemic changes in the body that can influence the severity of the disease. The irreversible changes to the lungs can be seen in limitations in the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX AC1 on exercise capacity and respiratory quality of life.
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
- •Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.
排除标准
- •Subject not qualifying because of physical or psychological condition that may put them at risk of participating.
研究组 & 干预措施
Experimental: Group A Anastomotic Coupler
Device: ROX Anastomotic Coupler System (ACS). The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
干预措施: Arteriovenous Fistula (ROX AC1) (Device)
结局指标
主要结局
Improvement in exercise capacity.
时间窗: 12 weeks post-procedure
次要结局
- Improvement in quality of life.(12 weeks post-procedure)