NCT07211035 · Amplifi Vascular, Inc.
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
(AMPLIFI-1)
What this study is about
The AMPLIFI-1 Study is a forward-looking, conducted at multiple hospitals 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 randomly assigned controlled (RC) group of participants of patients with suitable cephalic veins (≥2.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Boston, Massachusetts
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations