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

NCT07211035 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CLINP2113
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

End Stage Kidney Disease (ESRD)

Keywords

Pre-vein dilation for AVF access

Outcome Measures

Primary Outcomes (3)

• Physiologic AVF Maturation - RC (Amplifi vs Control)

  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.

  2 weeks post-AVF creation

• Physiologic AVF Maturation - NRC (Non-Inferiority vs RC Control)

  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).

  6 weeks post-AVF creation

• Incidence of Major Device- or Procedure-Related Adverse Events

  Proportion of subjects experiencing at least one major device- or procedure-related adverse event (MAE) within 30 days of AVF surgery following Amplifi treatment.

  Through 30 days after AVF creation (primary safety window)

Secondary Outcomes (8)

• Functional AVF Maturation

  Within 12 months post AVF creation

• Time to Catheter-Free Dialysis

  From AVF creation through 12 months

• Total Number of Interventions Required to Achieve and Maintain Functional and Secondary Patency

  3, 6, and 12 months post-AVF creation

• Proportion of AVFs Maintaining Secondary Patency

  6 and 12 months post-AVF creation

• Proportion of AVFs that remain clinically usable for dialysis at 12 months post-creation

  Through 12 months post AVF creation

Study Arms (3)

Arm 1: Amplifi + AVF (Randomized Cohort) Subjects with suitable veins (≥2.5 mm)

EXPERIMENTAL

Subjects with suitable veins (≥2.5 mm) randomized 2:1 to Amplifi treatment followed by surgical creation of a distal radiocephalic arteriovenous fistula (AVF).

Device: 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.

Arm 2: Active Comparator - Control AVF (Randomized Cohort)

ACTIVE COMPARATOR

Subjects with suitable veins (≥2.5 mm) randomized to control group, undergoing standard surgical creation of a distal radiocephalic AVF without Amplifi pretreatment.

Procedure: Standard of Care (AVF creation)

Arm 3: Experimental - Amplifi + AVF (Non-Randomized Small Vein Cohort)

EXPERIMENTAL

Subjects with borderline small veins (1.7-\<2.5 mm) enrolled into a non-randomized cohort, treated with Amplifi prior to surgical creation of a distal radiocephalic AVF.

Device: 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.

Interventions

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. DEVICE

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. By increasing wall shear stress, the device promotes physiologic vein dilation, enabling successful creation of a distal radiocephalic arteriovenous fistula (AVF) in patients with small or borderline veins.

Arm 1: Amplifi + AVF (Randomized Cohort) Subjects with suitable veins (≥2.5 mm); Arm 3: Experimental - Amplifi + AVF (Non-Randomized Small Vein Cohort)

Standard of Care (AVF creation) PROCEDURE

Standard of Care AVF creation

Arm 2: Active Comparator - Control AVF (Randomized Cohort)

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amplifi Vascular, Inc.: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts

CONTACT

19784080949; edeperalta@amplifivascular.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment with two randomized arms (Amplifi vs control) and one non-randomized small vein cohort

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 7, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04