Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (A… (NCT07211035) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of the Amplifiâ„¢ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
120 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice
✓. 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:
✓. 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.
✓. Palpable radial artery with a diameter of ≥ 2.0 mm at the site of proposed AVF creation without significant stenosis along the course
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
What they're measuring
1
Physiologic AVF Maturation - RC (Amplifi vs Control)
Timeframe: 2 weeks post-AVF creation
2
Physiologic AVF Maturation - NRC (Non-Inferiority vs RC Control)
Timeframe: 6 weeks post-AVF creation
3
Incidence of Major Device- or Procedure-Related Adverse Events
Timeframe: Through 30 days after AVF creation (primary safety window)
Trial details
NCT IDNCT07211035
SponsorAmplifi Vascular, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-06-01
Contact for this trial
Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts