End Stage Kidney Disease (ESRD)AMPLIFI-1NCT07211035
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
A study of End Stage Kidney Disease (ESRD), run by Amplifi Vascular, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease (ESRD)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 May 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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:
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- 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
Who cannot join
- 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
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- 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 atrial thrombus
- 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 such studies prior to the completion of the Study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts contact
United States2 sites, 2 recruiting
- Recruiting
Brigham Women's Hospital
Boston, Massachusetts, 02115
Hussain, Mohamad A MD, PhD
Mohamad Hussain, MD, PhD
- Recruiting
Flow Vascular
Houston, Texas, 77091
Karl Illig, MD
Karl Illig, MD
About this study
Official title: A Pivotal Study to Evaluate the Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and Arteriovenous Fistula Maturation
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.
Read the detailed description
AMPLIFI-1 is a staged, multicenter clinical investigation evaluating the safety and effectiveness of the Amplifi™ Vein Dilation System in patients with end-stage renal disease (ESRD) undergoing distal arteriovenous fistula (AVF) creation. The system provides controlled, continuous extracorporeal blood flow to the cephalic vein over 24 to 72 hours, inducing flow-mediated dilation prior to surgery.
The study includes two cohorts based on baseline cephalic vein diameter:
Randomized Controlled (RC) Cohort: Subjects with vein diameter ≥2.5 mm are randomized 2:1 to receive either Amplifi therapy followed by AVF creation or AVF creation alone. This cohort supports the primary effectiveness endpoint and provides the control group reference.
Non-Randomized Cohort (NRC): Subjects with borderline cephalic veins (1.7 mm to <2.5 mm) are treated with Amplifi therapy followed by AVF creation. Effectiveness is evaluated against a performance goal informed by the RC control group and external benchmarks.
The primary endpoint is physiologic AVF maturation at 2 weeks post-creation, defined as brachial artery flow ≥500 mL/min and outflow vein diameter ≥5 mm on duplex ultrasound. Secondary endpoints include functional maturation, AVF patency, and early safety events.
The study uses a staged approach beginning with a 5-subject initial safety cohort. All procedures follow a standardized AVF surgical and imaging protocol. The trial includes centralized core lab review of imaging and adverse event adjudication. Data from both cohorts will be analyzed separately and pooled to support a proposed indication spanning the studied vein size range.
- Conditions
- End Stage Kidney Disease (ESRD)
- Being tested
- 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., Standard of Care (AVF creation)
- Keywords
- Pre-vein dilation for AVF access
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
Standard of Care AVF creation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Amplifi + AVF (Randomized Cohort) Subjects with suitable veins (≥2.5 mm) | Experimental | Subjects with suitable veins (≥2.5 mm) randomized 2:1 to Amplifi treatment followed by surgical creation of a distal radiocephalic arteriovenous fistula (AVF). Receives: 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. |
| Arm 2: Active Comparator - Control AVF (Randomized Cohort) | Active comparator | Subjects with suitable veins (≥2.5 mm) randomized to control group, undergoing standard surgical creation of a distal radiocephalic AVF without Amplifi pretreatment. Receives: Procedure: Standard of Care (AVF creation) |
| Arm 3: Experimental - Amplifi + AVF (Non-Randomized Small Vein Cohort) | Experimental | 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic AVF Maturation - RC (Amplifi vs Control)
Proportion of RC subjects meeting physiologic maturation by duplex ultrasound, defined as cephalic vein diameter ≥ 5.0 mm and brachial artery flow ≥ 500 mL/min. Primary effectiveness comparison is Amplifi + AVF vs Standard AVF (control) in the RC.
Measured: 2 weeks post-AVF creation
Physiologic AVF Maturation - NRC (Non-Inferiority vs RC Control)
Proportion of NRC subjects meeting the same physiologic maturation definition (diameter ≥ 5.0 mm and flow ≥ 500 mL/min), analyzed for non-inferiority against the RC control arm using a prespecified NI margin (e.g., -20% absolute).
Measured: 6 weeks post-AVF creation
Incidence of Major Device- or Procedure-Related Adverse Events
Proportion of subjects experiencing at least one major device- or procedure-related adverse event (MAE) within 30 days of AVF surgery following Amplifi treatment.
Measured: Through 30 days after AVF creation (primary safety window)
Secondary outcomes (8)
Functional AVF Maturation
Proportion of subjects achieving functional use for hemodialysis, defined as successful two-needle cannulation at prescribed blood flow for ≥ 75% of sessions over a consecutive 4-week period.
Measured: Within 12 months post AVF creation
Time to Catheter-Free Dialysis
Days from AVF surgery to first successful dialysis using the study AVF without a central venous catheter.
Measured: From AVF creation through 12 months
Total Number of Interventions Required to Achieve and Maintain Functional and Secondary Patency
otal count of endovascular or surgical interventions required to achieve and maintain both functional and secondary AVF patency. Interventions may include angioplasty, thrombectomy, surgical revision, or other procedures intended to restore or maintain access patency.
Measured: 3, 6, and 12 months post-AVF creation
Proportion of AVFs Maintaining Secondary Patency
Proportion of AVFs that remain patent, with or without intervention, at 6 and 12 months following surgical creation. Secondary patency is defined as continued functional access use until abandonment, thrombosis, or surgical revision that precludes further use.
Measured: 6 and 12 months post-AVF creation
Proportion of AVFs that remain clinically usable for dialysis at 12 months post-creation
Proportion of AVFs that remain clinically usable for dialysis at 12 months following surgical creation, as determined by the ability to provide adequate dialysis without abandonment, thrombosis, or surgical revision that precludes use.
Measured: Through 12 months post AVF creation
Proportion of AVFs abandoned within 12 months
Proportion of AVFs abandoned within 12 months of surgical creation, with documentation of reasons for abandonment (e.g., failure to mature, infection, thrombosis, or dysfunction requiring abandonment).
Measured: 12 months post-AVF creation
Major Device-Related Adverse Events in Amplifi-Treated Subjects
Proportion of Amplifi-treated subjects experiencing ≥1 major device-related adverse event (AE). Major device-related AEs include device-attributed death; major bleeding, pneumothorax, air embolism, thrombosis, thromboembolism, hemolysis, or thrombocytopenia; localized device-related infection; Amplifi-related re-hospitalization, prolonged hospitalization, or major surgery; and any complication adjudicated by the Investigator and Clinical Events Committee (CEC) as both major and device-related.
Measured: From Amplifi System implantation through 30 days post-device removal and AVF creation
Overall Adverse Event Rate
Proportion of all subjects (Amplifi-treated and control) experiencing any adverse event during the first 6 months of study participation.
Measured: 6 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start12 May 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment with two randomized arms (Amplifi vs control) and one non-randomized small vein cohort
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amplifi Vascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211035
- Sponsor's protocol ID
- CLINP2113
- Acronym
- AMPLIFI-1
- Status last verified
- May 2026
- First submitted
- 30 Sep 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study to Evaluate the Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and Arteriovenous Fistula Maturation
- ClinicalTrials.gov ID
- NCT07211035
- Acronym / sponsor ID
- AMPLIFI-1 / CLINP2113
- Conditions
- End Stage Kidney Disease (ESRD)
- Keywords
- Pre-vein dilation for AVF access
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Amplifi Vascular, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 May 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AMPLIFI-1 is a staged, multicenter clinical investigation evaluating the safety and effectiveness of the Amplifi™ Vein Dilation System in patients with end-stage renal disease (ESRD) undergoing distal arteriovenous fistula (AVF) creation. The system provides controlled, continuous extracorporeal blood flow to the cephalic vein over 24 to 72 hours, inducing flow-mediated dilation prior to surgery.
The study includes two cohorts based on baseline cephalic vein diameter:
Randomized Controlled (RC) Cohort: Subjects with vein diameter ≥2.5 mm are randomized 2:1 to receive either Amplifi therapy followed by AVF creation or AVF creation alone. This cohort supports the primary effectiveness endpoint and provides the control group reference.
Non-Randomized Cohort (NRC): Subjects with borderline cephalic veins (1.7 mm to <2.5 mm) are treated with Amplifi therapy followed by AVF creation. Effectiveness is evaluated against a performance goal informed by the RC control group and external benchmarks.
The primary endpoint is physiologic AVF maturation at 2 weeks post-creation, defined as brachial artery flow ≥500 mL/min and outflow vein diameter ≥5 mm on duplex ultrasound. Secondary endpoints include functional maturation, AVF patency, and early safety events.
The study uses a staged approach beginning with a 5-subject initial safety cohort. All procedures follow a standardized AVF surgical and imaging protocol. The trial includes centralized core lab review of imaging and adverse event adjudication. Data from both cohorts will be analyzed separately and pooled to support a proposed indication spanning the studied vein size range.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel assignment with two randomized arms (Amplifi vs control) and one non-randomized small vein cohort
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Amplifi + AVF (Randomized Cohort) Subjects with suitable veins (≥2.5 mm) | Experimental | 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.Subjects with suitable veins (≥2.5 mm) randomized 2:1 to Amplifi treatment followed by surgical creation of a distal radiocephalic arteriovenous fistula (AVF). |
| Arm 2: Active Comparator - Control AVF (Randomized Cohort) | Active comparator | Procedure: Standard of Care (AVF creation)Subjects with suitable veins (≥2.5 mm) randomized to control group, undergoing standard surgical creation of a distal radiocephalic AVF without Amplifi pretreatment. |
| Arm 3: Experimental - Amplifi + AVF (Non-Randomized Small Vein Cohort) | Experimental | 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.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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 placement, including:
- Palpable radial artery with a diameter of ≥ 2.0 mm at the site of proposed AVF creation without significant stenosis along the course
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.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. | Device | Arm 1: Amplifi + AVF (Randomized Cohort) Subjects with suitable veins (≥2.5 mm), Arm 3: Experimental - Amplifi + AVF (Non-Randomized Small Vein Cohort) |
| Standard of Care (AVF creation)Standard of Care AVF creation | Procedure or surgery | Arm 2: Active Comparator - Control AVF (Randomized Cohort) |
Primary outcome
Physiologic AVF Maturation - RC (Amplifi vs Control)
Time frame: 2 weeks post-AVF creation
Proportion of RC subjects meeting physiologic maturation by duplex ultrasound, defined as cephalic vein diameter ≥ 5.0 mm and brachial artery flow ≥ 500 mL/min. Primary effectiveness comparison is Amplifi + AVF vs Standard AVF (control) in the RC.
Physiologic AVF Maturation - NRC (Non-Inferiority vs RC Control)
Time frame: 6 weeks post-AVF creation
Proportion of NRC subjects meeting the same physiologic maturation definition (diameter ≥ 5.0 mm and flow ≥ 500 mL/min), analyzed for non-inferiority against the RC control arm using a prespecified NI margin (e.g., -20% absolute).
Incidence of Major Device- or Procedure-Related Adverse Events
Time frame: Through 30 days after AVF creation (primary safety window)
Proportion of subjects experiencing at least one major device- or procedure-related adverse event (MAE) within 30 days of AVF surgery following Amplifi treatment.
8 secondary outcomes
Functional AVF Maturation
Time frame: Within 12 months post AVF creation
Time to Catheter-Free Dialysis
Time frame: From AVF creation through 12 months
Total Number of Interventions Required to Achieve and Maintain Functional and Secondary Patency
Time frame: 3, 6, and 12 months post-AVF creation
Proportion of AVFs Maintaining Secondary Patency
Time frame: 6 and 12 months post-AVF creation
Proportion of AVFs that remain clinically usable for dialysis at 12 months post-creation
Time frame: Through 12 months post AVF creation
Proportion of AVFs abandoned within 12 months
Time frame: 12 months post-AVF creation
Major Device-Related Adverse Events in Amplifi-Treated Subjects
Time frame: From Amplifi System implantation through 30 days post-device removal and AVF creation
Overall Adverse Event Rate
Time frame: 6 months post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of End Stage Kidney Disease (ESRD), run by Amplifi Vascular, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erdie De Peralta Vice President, Regulatory and Clinical Affairs, Master of Arts (19784080949, edeperalta@amplifivascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiologic AVF Maturation - RC (Amplifi vs Control) (time frame: 2 weeks post-AVF creation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.