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AMPLIFI-1 Study: Amplifi™ Vein Dilation System for AV Fistula Maturation

The AMPLIFI-1 study is testing a new device called the Amplifi™ Vein Dilation System for people with End Stage Kidney Disease (ESRD) who need an AV fistula (a connection between an artery and a vein) for hemodialysis. The Amplifi System is a temporary blood pump that helps widen a vein before the AV fistula is created. This study wants to see if using the Amplifi System helps the AV fistula mature (become ready for use) better than standard care. To join, you must be at least 18 years old, have ESRD, and be scheduled for a specific type of AV fistula in your wrist or forearm. The study is looking for 160 participants, but its current status is unclear.

Study design
This is an interventional study with two groups: one where participants are randomly assigned to receive the Amplifi System or standard care, and another where participants with smaller veins all receive the Amplifi System. The study plans to enroll 160 participants.
What's involved
The Amplifi System is used for 24-72 hours prior to AV fistula creation. Participants will have their AV fistula maturation measured at 2 weeks and 6 weeks after creation.
Compensation
Not stated in the trial record.
Follow-up
Safety events are monitored through 30 days after AV fistula creation. AV fistula maturation is measured at 2 weeks and 6 weeks post-creation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07211035

Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)

Recruiting
NAAges 18+InterventionalTreatment
Amplifi Vascular, Inc.
~160 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested: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.Standard of Care (AVF creation)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Physiologic AVF Maturation - RC (Amplifi vs Control)
Measured over 2 weeks post-AVF creation
+2 more outcomes measured

Conditions

End Stage Kidney Disease (ESRD)

Explore related trials

Chronic Kidney Disease, Stage 5

Where it's being run

2 sites across 2 states
Massachusetts1
Texas1

Who to contact

Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts
[email protected]
19784080949
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

What this trial measures

  • 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 EventsThrough 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.