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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Amplifi Vascular, Inc.
Study ID
NCT07211035
Status
Recruiting
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Conditions

  • End Stage Kidney Disease (ESRD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Standard of Care (AVF creation) — PROCEDURE
    Standard of Care AVF creation

Study Details

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.

Key Dates

Start date
May 12, 2026
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Amplifi + AVF (Randomized Cohort) Subjects with suitable veins (≥2.5 mm)
    Subjects with suitable veins (≥2.5 mm) randomized 2:1 to Amplifi treatment followed by surgical creation of a distal radiocephalic arteriovenous fistula (AVF).
  • Active Comparator: Arm 2: Active Comparator - Control AVF (Randomized Cohort)
    Subjects with suitable veins (≥2.5 mm) randomized to control group, undergoing standard surgical creation of a distal radiocephalic AVF without Amplifi pretreatment.
  • Experimental: Arm 3: Experimental - Amplifi + AVF (Non-Randomized Small Vein Cohort)
    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.

Primary Outcome Measure

Physiologic AVF Maturation - RC (Amplifi vs Control) [ Time Frame: 2 weeks post-AVF creation ]

Central Contacts

  • Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts
    19784080949
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham Women's HospitalBostonMassachusetts02115-

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By research site
Brigham Women's Hospital· Boston, MA

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