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New treatment option for End Stage Kidney Disease (ESRD)
Official title Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
ClinicalTrials.gov ID: NCT07211035
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- A forearm cephalic vein segment of ≥ 14 cm in length that provides an approximately 10 cm cannulation zone, free of detectable occlusions or...
You likely can't join 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
See the full eligibility criteria
- 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...
- 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
- 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...
- 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
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.