A Pivotal Study to Evaluate the Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and Arteriovenous Fistula Maturation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Physiologic AVF Maturation - RC (Amplifi vs Control)
研究概览
简要总结
The AMPLIFI-1 Study is a prospective, multicenter pivotal clinical trial designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula (AVF) creation for hemodialysis. The study has two cohorts: a randomized controlled (RC) cohort of patients with suitable cephalic veins (≥2.5 mm) randomized 2:1 to Amplifi treatment plus AVF creation versus standard AVF creation alone, and a non-randomized small vein cohort (NRC) of patients with borderline veins (1.7 to <2.5 mm) treated with Amplifi therapy followed by AVF creation.
详细描述
AMPLIFI-1 is a staged, multicenter clinical investigation evaluating the safety and effectiveness of the Amplifi™ Vein Dilation System in patients with end-stage renal disease (ESRD) undergoing distal arteriovenous fistula (AVF) creation. The system provides controlled, continuous extracorporeal blood flow to the cephalic vein over 24 to 72 hours, inducing flow-mediated dilation prior to surgery.
The study includes two cohorts based on baseline cephalic vein diameter:
Randomized Controlled (RC) Cohort: Subjects with vein diameter ≥2.5 mm are randomized 2:1 to receive either Amplifi therapy followed by AVF creation or AVF creation alone. This cohort supports the primary effectiveness endpoint and provides the control group reference.
Non-Randomized Cohort (NRC): Subjects with borderline cephalic veins (1.7 mm to <2.5 mm) are treated with Amplifi therapy followed by AVF creation. Effectiveness is evaluated against a performance goal informed by the RC control group and external benchmarks.
The primary endpoint is physiologic AVF maturation at 2 weeks post-creation, defined as brachial artery flow ≥500 mL/min and outflow vein diameter ≥5 mm on duplex ultrasound. Secondary endpoints include functional maturation, AVF patency, and early safety events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •End-Stage Renal Disease (ESRD) receiving maintenance hemodialysis.
- •Baseline cephalic vein diameter between >1.7 mm and <3.2 mm at the proposed Study AVF creation site in the distal forearm, with a continuous distal segment or tributary suitable for Amplifi System Outflow Catheter placement, including:
- •A forearm cephalic vein segment of ≥ 14 cm in length that provides an approximately 10 cm cannulation zone, free of detectable occlusions or stenosis, with collaterals.
- •Central continuity of the forearm cephalic vein at the elbow demonstrated through one or any combination of the following pathways:
- •the upper arm cephalic vein,
- •the median cubital vein connecting to the upper arm basilic vein,
- •the perforator vein connecting to the deep venous system.
- •Upper arm veins must show central continuity with no detectable occlusions.
- •Palpable radial artery with a diameter of ≥ 2.0 mm at the site of proposed AVF creation without significant stenosis along the course
- •Positive Allen's Test
- •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 to 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 from uncorrected coagulopathy
- •Known thrombophilia, requiring treatment
- •Hb <7 gm/dL
- •Platelet level < 100,000 /mm3
- •Significant radial artery calcification
- •Need for continued treatment with anti-platelet agents or other 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
- •Known presence or recent history of intracranial or gastrointestinal bleeding or presence of underlying conditions that would predispose to intracranial or internal bleeding. Documented recent central venous or right atrial thrombus
- •History of recent ipsilateral central venous occlusion, stenosis > 50%, angioplasty, or stent placement
- •Pregnancy, lactation, or plans to become pregnant during the Study
- •Expected survival less than 12 months
- •Unwillingness or inability to comply with procedures specified in the Protocol, or difficulty or inability to return for follow-up visits as specified by the Protocol
- •Participation in any other investigational drug or medical device study that has not completed primary endpoint evaluation or clinically interferes with the endpoints from the Study, or planned future participation in such studies prior to the completion of the Study
研究组 & 干预措施
Arm 1: Amplifi + AVF (Randomized Cohort) Subjects with suitable veins (≥2.5 mm)
Subjects with suitable veins (≥2.5 mm) randomized 2:1 to Amplifi treatment followed by surgical creation of a distal radiocephalic arteriovenous fistula (AVF).
干预措施: The Amplifi System is a temporary extracorporeal blood pump designed to deliver controlled flow through a peripheral vein for 24-72 hours prior to AVF creation. (Device)
Arm 3: Experimental - Amplifi + AVF (Non-Randomized Small Vein Cohort)
Subjects with borderline small veins (1.7-<2.5 mm) enrolled into a non-randomized cohort, treated with Amplifi prior to surgical creation of a distal radiocephalic AVF.
干预措施: The Amplifi System is a temporary extracorporeal blood pump designed to deliver controlled flow through a peripheral vein for 24-72 hours prior to AVF creation. (Device)
Arm 2: Active Comparator - Control AVF (Randomized Cohort)
Subjects with suitable veins (≥2.5 mm) randomized to control group, undergoing standard surgical creation of a distal radiocephalic AVF without Amplifi pretreatment.
干预措施: Standard of Care (AVF creation) (Procedure)
结局指标
主要结局
Physiologic AVF Maturation - RC (Amplifi vs Control)
时间窗: 2 weeks post-AVF creation
Proportion of RC subjects meeting physiologic maturation by duplex ultrasound, defined as cephalic vein diameter ≥ 5.0 mm and brachial artery flow ≥ 500 mL/min. Primary effectiveness comparison is Amplifi + AVF vs Standard AVF (control) in the RC.
Physiologic AVF Maturation - NRC (Non-Inferiority vs RC Control)
时间窗: 6 weeks post-AVF creation
Proportion of NRC subjects meeting the same physiologic maturation definition (diameter ≥ 5.0 mm and flow ≥ 500 mL/min), analyzed for non-inferiority against the RC control arm using a prespecified NI margin (e.g., -20% absolute).
Incidence of Major Device- or Procedure-Related Adverse Events
时间窗: Through 30 days after AVF creation (primary safety window)
Proportion of subjects experiencing at least one major device- or procedure-related adverse event (MAE) within 30 days of AVF surgery following Amplifi treatment.
次要结局
- Functional AVF Maturation(Within 12 months post AVF creation)
- Time to Catheter-Free Dialysis(From AVF creation through 12 months)
- Total Number of Interventions Required to Achieve and Maintain Functional and Secondary Patency(3, 6, and 12 months post-AVF creation)
- Proportion of AVFs Maintaining Secondary Patency(6 and 12 months post-AVF creation)
- Proportion of AVFs that remain clinically usable for dialysis at 12 months post-creation(Through 12 months post AVF creation)
- Proportion of AVFs abandoned within 12 months(12 months post-AVF creation)
- Major Device-Related Adverse Events in Amplifi-Treated Subjects(From Amplifi System implantation through 30 days post-device removal and AVF creation)
- Overall Adverse Event Rate(6 months post-enrollment)