End Stage Kidney Disease (ESRD)
Conditions
Keywords
Pre-vein dilation for AVF access
Brief summary
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.
Detailed description
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. The study uses a staged approach beginning with a 5-subject initial safety cohort. All procedures follow a standardized AVF surgical and imaging protocol. The trial includes centralized core lab review of imaging and adverse event adjudication. Data from both cohorts will be analyzed separately and pooled to support a proposed indication spanning the studied vein size range.
Interventions
DEVICEThe 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.
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. By increasing wall shear stress, the device promotes physiologic vein dilation, enabling successful creation of a distal radiocephalic arteriovenous fistula (AVF) in patients with small or borderline veins.
PROCEDUREStandard of Care (AVF creation)
Standard of Care AVF creation
Sponsors
Amplifi Vascular, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel assignment with two randomized arms (Amplifi vs control) and one non-randomized small vein cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice 3. End-Stage Renal Disease (ESRD) receiving maintenance hemodialysis. 4. 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: 1. the upper arm cephalic vein, 2. the median cubital vein connecting to the upper arm basilic vein, 3. the perforator vein connecting to the deep venous system. * Upper arm veins must show central continuity with no detectable occlusions. 5. Palpable radial artery with a diameter of ≥ 2.0 mm at the site of proposed AVF creation without significant stenosis along the course 6. Positive Allen's Test 7. At least one patent internal jugular vein suitable for Amplifi Inflow Catheter insertion 8. Subject has voluntarily signed written informed consent
Exclusion criteria
1. Known allergy to Amplifi System components (polyurethane, nitinol), iodinated contrast agents, heparin, or apixaban 2. Known or suspected active infection at the proposed time of Amplifi System placement 3. Known bleeding diathesis, including from uncorrected coagulopathy 4. Known thrombophilia, requiring treatment 5. Hb \<7 gm/dL 6. Platelet level \< 100,000 /mm3 7. Significant radial artery calcification 8. Need for continued treatment with anti-platelet agents or other anticoagulants (other than apixaban) during the Amplifi System treatment period 9. Known history of patent foramen ovale \> 2 mm 10. History of recent intracranial or gastrointestinal bleeding 11. Documented recent central venous or right atrial thrombus 12. 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 13. History of recent ipsilateral central venous occlusion, stenosis \> 50%, angioplasty, or stent placement 14. Pregnancy, lactation, or plans to become pregnant during the Study 15. Expected survival less than 12 months 16. 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 17. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiologic AVF Maturation - RC (Amplifi vs Control) | 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) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional AVF Maturation | Within 12 months post AVF creation | Proportion of subjects achieving functional use for hemodialysis, defined as successful two-needle cannulation at prescribed blood flow for ≥ 75% of sessions over a consecutive 4-week period. |
| Time to Catheter-Free Dialysis | From AVF creation through 12 months | Days from AVF surgery to first successful dialysis using the study AVF without a central venous catheter. |
| Total Number of Interventions Required to Achieve and Maintain Functional and Secondary Patency | 3, 6, and 12 months post-AVF creation | otal count of endovascular or surgical interventions required to achieve and maintain both functional and secondary AVF patency. Interventions may include angioplasty, thrombectomy, surgical revision, or other procedures intended to restore or maintain access patency. |
| Proportion of AVFs Maintaining Secondary Patency | 6 and 12 months post-AVF creation | Proportion of AVFs that remain patent, with or without intervention, at 6 and 12 months following surgical creation. Secondary patency is defined as continued functional access use until abandonment, thrombosis, or surgical revision that precludes further use. |
| Proportion of AVFs that remain clinically usable for dialysis at 12 months post-creation | Through 12 months post AVF creation | Proportion of AVFs that remain clinically usable for dialysis at 12 months following surgical creation, as determined by the ability to provide adequate dialysis without abandonment, thrombosis, or surgical revision that precludes use. |
| Proportion of AVFs abandoned within 12 months | 12 months post-AVF creation | Proportion of AVFs abandoned within 12 months of surgical creation, with documentation of reasons for abandonment (e.g., failure to mature, infection, thrombosis, or dysfunction requiring abandonment). |
| Major Device-Related Adverse Events in Amplifi-Treated Subjects | From Amplifi System implantation through 30 days post-device removal and AVF creation | Proportion of Amplifi-treated subjects experiencing ≥1 major device-related adverse event (AE). Major device-related AEs include device-attributed death; major bleeding, pneumothorax, air embolism, thrombosis, thromboembolism, hemolysis, or thrombocytopenia; localized device-related infection; Amplifi-related re-hospitalization, prolonged hospitalization, or major surgery; and any complication adjudicated by the Investigator and Clinical Events Committee (CEC) as both major and device-related. |
| Overall Adverse Event Rate | 6 months post-enrollment | Proportion of all subjects (Amplifi-treated and control) experiencing any adverse event during the first 6 months of study participation. |
Countries
United States
Contacts
CONTACTErdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts
Outcome results
None listed