Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3

NCT07058610 | Completed FDA Device

• 1 other identifier: CLINP1837
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation. Conducted at a single site outside the United States, subjects were enrolled across multiple phases. The study focused on device-related safety, procedural success, percent change in vein dilation and AVF maturation outcomes.

Conditions

End-Stage Renal Disease Requiring Haemodialysis

Keywords

Amplifi; Pre-dilation

Outcome Measures

Primary Outcomes (5)

• Rate of AVF Maturation at 2 and 6 Weeks

  From post AVF creation to end of 6 weeks follow-up.

• Percent Change in Cephalic Vein Diameter and Blood Flow

  From baseline, during Amplifi System treatment (minimum daily), and prior to Amplifi System removal and AVF creation]

• Mean vein diameter of the cephalic vein and blood flow of brachial artery

  2 and 6 weeks post AVF creation

• Percentage of subjects who experience an increase in the cephalic vein diameter of ≥2.7 mm from their baseline measurement, or an increase of >1 mm from baseline, following treatment with the Amplifi System.

  From baseline measurement to intra-procedural assessment immediately prior to Amplifi System removal and AVF creation (same procedure day)

• Rate of Occurrence of Major Device-Related Adverse Events

  from device implantation and up to 30 days from device removal and AVF creation

Study Arms (1)

Interventional arm

EXPERIMENTAL

Single arm study

Device: Amplifi Vein Dilation System

Interventions

Amplifi Vein Dilation System DEVICE

An investigational extracorporeal blood pump and catheter system designed to promote vein dilation prior to AVF creation.

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice
• ESRD currently receiving maintenance hemodialysis via a tunneled, cuffed hemodialysis catheter
• Baseline wrist or distal forearm cephalic vein diameter of \>= 1.7 mm and \< 3.2 mm at the proposed Study AVF creation site, wherein the wrist or forearm cephalic vein at the proposed Study AVF creation site is suitable for Amplifi Distal Outflow Catheter placement and Amplifi System treatment, including:
• \>= 1.7 mm to \< 3.2 mm diameter of the wrist or forearm cephalic vein at the proposed Study AVF creation site;
• patency and continuity of blood flow from the proposed Study AVF creation site centrally to the upper arm at the elbow through at least one or more of: 1) the upper arm cephalic vein; 2) the median cubital vein to the upper arm basilic system; or 3) the perforator vein to the deep venous system; and
• no occlusion or stenosis \> 50% along the course of the forearm cephalic vein and at least one upper arm venous outflow up to the subclavian vein, as determined by duplex ultrasonography
• Estimated forearm hemodialysis needle cannulation zone length \> 18 cm after creation of the proposed Study AVF
• At least one patent internal jugular vein suitable for Amplifi Inflow Catheter insertion
• Subject has voluntarily signed written informed consent

You may not qualify if:

• Known allergy or hypersensitivity to any 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 uncorrected coagulopathy
• Known thrombophilia requiring treatment
• Hemoglobin \< 10 g/dL
• Platelet count \< 100,000/mm³
• Requirement for continued treatment with antiplatelet agents or 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
• History of recent ipsilateral central venous occlusion, \> 50% stenosis, angioplasty, or stent placement
• Pregnancy, lactation, or plans to become pregnant during the study
• Unwillingness or inability to comply with protocol-specified procedures or follow-up visits
• Participation in another investigational drug or medical device study that has not completed primary endpoint evaluation, that could clinically interfere with study endpoints, or planned participation in such a study prior to completion of this study

Sponsors & Collaborators

• Amplifi Vascular, Inc.: lead

Study Sites (1)

Sanatorio Italiano

Asunción, 1849, Paraguay

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: December 8, 2020
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-07

Locations

PA (1)