Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (A… (NCT07211035) | Clinical Trial Compass
RecruitingNot Applicable
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
United States160 participantsStarted 2026-05-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years
. Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice
. 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:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Physiologic AVF Maturation - RC (Amplifi vs Control)
Timeframe: 2 weeks post-AVF creation
2
Physiologic AVF Maturation - NRC (Non-Inferiority vs RC Control)
Timeframe: 6 weeks post-AVF creation
3
Incidence of Major Device- or Procedure-Related Adverse Events
Timeframe: Through 30 days after AVF creation (primary safety window)
Trial details
NCT IDNCT07211035
SponsorAmplifi Vascular, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-06-01
Contact for this trial
Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts