Actively Recruiting
A Pivotal Study to Evaluate the Effect of the Amplifi12 Vein Dilation System on Outflow Vein Dilation and Arteriovenous Fistula Maturation
Led by Amplifi Vascular, Inc. · Updated on 2026-05-20
160
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Amplifi12 Vein Dilation System in patients with end-stage renal disease (ESRD) who need distal arteriovenous fistula (AVF) creation for hemodialysis. This prospective, multicenter pivotal clinical trial includes two groups based on the size of the patient's cephalic vein. The study aims to determine if the Amplifi system improves vein dilation and AVF maturation compared to standard AVF creation alone. The Amplifi System is a temporary extracorporeal blood pump that delivers controlled blood flow through the peripheral vein for 24 to 72 hours before surgery. Patients with suitable veins (2.5 mm or larger) are randomized 2:1 to receive either Amplifi therapy followed by AVF creation or AVF creation alone. Patients with borderline smaller veins (1.7 to less than 2.5 mm) receive Amplifi therapy followed by AVF creation in a separate non-randomized cohort. The study starts with a small safety group and uses standardized surgical and imaging protocols. Participants will undergo imaging assessments including duplex ultrasound to measure AVF maturation at 2 and 6 weeks post-surgery. Researchers will monitor vein size, blood flow, and adverse events through 12 months. Additional evaluations include functional AVF use, patency rates, and number of interventions needed. Safety monitoring continues through 30 days after AVF creation and overall adverse events are tracked for 6 months. The study includes follow-up visits and data reviews to assess the device's performance and patient outcomes.
CONDITIONS
Brief Title
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice
- Diagnosed with End-Stage Renal Disease (ESRD) and receiving maintenance hemodialysis
- Baseline cephalic vein diameter greater than 1.7 mm and less than 3.2 mm at the proposed AVF creation site
- Forearm cephalic vein segment of at least 14 cm in length with an approximately 10 cm cannulation zone free of occlusions or stenosis
- Central continuity of the forearm cephalic vein through specified pathways with no occlusions
- Radial artery at proposed AVF site with a diameter of at least 2.0 mm without significant stenosis
- Positive Allen's Test
- At least one patent internal jugular vein suitable for Amplifi Inflow Catheter insertion
- Voluntarily signed written informed consent
You will not qualify if you...
- Known allergy to Amplifi System components (polyurethane, nitinol), iodinated contrast agents, heparin, or apixaban
- Known or suspected active infection at time of Amplifi System placement
- Known bleeding diathesis including uncorrected coagulopathy
- Known thrombophilia requiring treatment
- Hemoglobin less than 7 gm/dL
- Platelet count less than 100,000/mm3
- Significant radial artery calcification
- Need for continued treatment with antiplatelet agents or other anticoagulants (other than apixaban) during Amplifi treatment
- Known history of patent foramen ovale greater than 2 mm
- History of recent intracranial or gastrointestinal bleeding
- Recent central venous or right atrial thrombus
- Recent ipsilateral central venous occlusion, stenosis greater than 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 study procedures or follow-up visits
- Participation in any other investigational drug or device study that interferes with this study's endpoints or planned future participation prior to study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 to 72 hours
Participants receive Amplifi therapy, which involves controlled extracorporeal blood flow through the cephalic vein for 24 to 72 hours to promote vein dilation prior to arteriovenous fistula (AVF) surgery.
1 visit (in-person) for device placement and monitoring
Duration - 1 day
Participants undergo surgical creation of a distal radiocephalic arteriovenous fistula (AVF) following Amplifi therapy or as standard care for control participants.
1 visit (in-person) for AVF creation
Duration - Up to 12 months
Participants are monitored for AVF maturation, safety, and functional outcomes after surgery, including assessment of vein dilation and blood flow.
Multiple visits including assessments at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months post-AVF creation
Trial Site Locations
Total: 1 location
1
Brigham Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
E
Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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