Amplifi Vein Dilation System to Aid AV Fistula Maturation in ESRD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

AMPLIFI-1 is a multicenter, prospective trial evaluating the safety and effectiveness of temporarily circulating blood through a vein to dilate it before AVF creation. It includes a randomized cohort with vein diameters ≥2.5 mm and a non-randomized cohort with borderline veins (1.7 to <2.5 mm), comparing Amplifi plus AVF to standard AVF creation and to historical/benchmark expectations. The primary endpoint is physiologic AVF maturation at 2 weeks, defined by brachial artery flow and outflow vein size on duplex ultrasound. Secondary endpoints cover functional maturation, AVF patency, and early safety events, with imaging reviewed centrally. The study follows standardized surgical and imaging protocols across sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice
3. End-Stage Renal Disease (ESRD) receiving maintenance hemodialysis.
4. 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:

     1. the upper arm cephalic vein,
     2. the median cubital vein connecting to the upper arm basilic vein,
     3. the perforator vein connecting to the deep venous system.
   * Upper arm veins must show central continuity with no detectable occlusions.
5. Palpable radial artery with a diameter of ≥ 2.0 mm at the site of proposed AVF creation without significant stenosis along the course
6. Positive Allen's Test
7. At least one patent internal jugular vein suitable for Amplifi Inflow Catheter insertion
8. Subject has voluntarily signed written informed consent

Exclusion Criteria:

1. Known allergy to Amplifi System components (polyurethane, nitinol), iodinated contrast agents, heparin, or apixaban
2. Known or suspected active infection at the proposed time of Amplifi System placement
3. Known bleeding diathesis, including from uncorrected coagulopathy
4. Known thrombophilia, requiring treatment
5. Hb \<7 gm/dL
6. Platelet level \< 100,000 /mm3
7. Significant radial artery calcification
8. Need for continued treatment with anti-platelet agents or other anticoagulants (other than apixaban) during the Amplifi System treatment period
9. Known history of patent foramen ovale \> 2 mm
10. History of recent intracranial or gastrointestinal bleeding
11. Documented recent central venous or right atrial thrombus
12. 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
13. History of recent ipsilateral central venous occlusion, stenosis \> 50%, angioplasty, or stent placement
14. Pregnancy, lactation, or plans to become pregnant during the Study
15. Expected survival less than 12 months
16. Unwillingness or inability to comply with procedures specified in the Protocol, or difficulty or inability to return for follow-up visits as specified by the Protocol
17. Participation in any other investigational drug or medical device study that has not completed primary endpoint evaluation or clinically interferes with the endpoints from the Study, or planned future participation in such studies prior to the completion of the Study

Where it's running

• Brigham Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Flow Vascular
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts
• Email: edeperalta@amplifivascular.com
• Phone: 19784080949

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.