Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Percent Change in Cephalic Vein Diameter and Blood Flow
研究概览
简要总结
This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation. Conducted at a single site outside the United States, subjects were enrolled across multiple phases. The study focused on device-related safety, procedural success, percent change in vein dilation and AVF maturation outcomes.
详细描述
The Amplifi System was used to promote vein dilation prior to AVF creation. Subjects with ESRD or CKD were treated across three phases of enrollment. The protocol incorporated learnings from earlier phases, including improvements to the device design and procedural protocols. This registration covers all phases of the study (Phase 1-3), with updates planned as new data becomes available.
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
- •Age ≥ 18 years
- •Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice
- •ESRD currently receiving maintenance hemodialysis via a tunneled, cuffed hemodialysis catheter
- •Baseline wrist or distal forearm cephalic vein diameter of >= 1.7 mm and < 3.2 mm at the proposed Study AVF creation site, wherein the wrist or forearm cephalic vein at the proposed Study AVF creation site is suitable for Amplifi Distal Outflow Catheter placement and Amplifi System treatment, including:
- •>= 1.7 mm to < 3.2 mm diameter of the wrist or forearm cephalic vein at the proposed Study AVF creation site;
- •patency and continuity of blood flow from the proposed Study AVF creation site centrally to the upper arm at the elbow through at least one or more of: 1) the upper arm cephalic vein; 2) the median cubital vein to the upper arm basilic system; or 3) the perforator vein to the deep venous system; and
- •no occlusion or stenosis > 50% along the course of the forearm cephalic vein and at least one upper arm venous outflow up to the subclavian vein, as determined by duplex ultrasonography
- •Estimated forearm hemodialysis needle cannulation zone length > 18 cm after creation of the proposed Study AVF
- •At least one patent internal jugular vein suitable for Amplifi Inflow Catheter insertion
- •Subject has voluntarily signed written informed consent
排除标准
- •Known allergy or hypersensitivity to any Amplifi System components (polyurethane, nitinol), iodinated contrast agents, heparin, or apixaban
- •Known or suspected active infection at the proposed time of Amplifi System placement
- •Known bleeding diathesis, including uncorrected coagulopathy
- •Known thrombophilia requiring treatment
- •Hemoglobin < 10 g/dL
- •Platelet count < 100,000/mm³
- •Requirement for continued treatment with antiplatelet agents or anticoagulants other than apixaban during the Amplifi System treatment period
- •Known history of patent foramen ovale > 2 mm
- •History of recent intracranial or gastrointestinal bleeding
- •Documented recent central venous or right atrial thrombus
- •History of recent ipsilateral central venous occlusion, > 50% stenosis, angioplasty, or stent placement
- •Pregnancy, lactation, or plans to become pregnant during the study
- •Unwillingness or inability to comply with protocol-specified procedures or follow-up visits
- •Participation in another investigational drug or medical device study that has not completed primary endpoint evaluation, that could clinically interfere with study endpoints, or planned participation in such a study prior to completion of this study
结局指标
主要结局
Percent Change in Cephalic Vein Diameter and Blood Flow
时间窗: From baseline, during Amplifi System treatment (minimum daily), and prior to Amplifi System removal and AVF creation]
Rate of AVF Maturation at 2 and 6 Weeks
时间窗: From post AVF creation to end of 6 weeks follow-up.
Mean vein diameter of the cephalic vein and blood flow of brachial artery
时间窗: 2 and 6 weeks post AVF creation
Rate of Occurrence of Major Device-Related Adverse Events
时间窗: from device implantation and up to 30 days from device removal and AVF creation
Rate of AVF Maturation at 2 and 6 Weeks
时间窗: From post AVF creation to end of 6 weeks follow-up.
Mean vein diameter of the cephalic vein and blood flow of brachial artery
时间窗: 2 and 6 weeks post AVF creation
Percent Change in Cephalic Vein Diameter and Blood Flow
时间窗: From baseline, during Amplifi System treatment (minimum daily), and prior to Amplifi System removal and AVF creation]
Percentage of subjects who experience an increase in the cephalic vein diameter of ≥2.7 mm from their baseline measurement, or an increase of >1 mm from baseline, following treatment with the Amplifi System.
时间窗: From baseline measurement to intra-procedural assessment immediately prior to Amplifi System removal and AVF creation (same procedure day)
Rate of Occurrence of Major Device-Related Adverse Events
时间窗: from device implantation and up to 30 days from device removal and AVF creation
次要结局
未报告次要终点