NCT07211035 Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
| NCT ID | NCT07211035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amplifi Vascular, Inc. |
| Condition | End Stage Kidney Disease (ESRD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2026-05-12 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts
✉ edeperalta@amplifivascular.com📞 19784080949
Frequently Asked Questions
Who can join the NCT07211035 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying End Stage Kidney Disease (ESRD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07211035 currently recruiting?
Yes, NCT07211035 is actively recruiting participants. Contact the research team at edeperalta@amplifivascular.com for enrollment information.
Where is the NCT07211035 trial being conducted?
This trial is being conducted at Boston, United States, Houston, United States.
Who is sponsoring the NCT07211035 clinical trial?
NCT07211035 is sponsored by Amplifi Vascular, Inc.. The trial plans to enroll 160 participants.
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