AzTrials
AzTrials

Chronic Kidney Disease Requiring HemodialysisVENOS-2NCT06712251

Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access

A study testing Velocity pAVF System in people with Chronic Kidney Disease Requiring Hemodialysis and End Stage Renal Disease (ESRD), run by Venova Medical at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Velocity pAVF System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesUnited States
Study dates
8 Jan 2025to 4 Jan 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • CKD stage 4/5 or ESRD
  • Eligible for a native surgical proximal forearm radiocephalic arteriovenous fistula following assessment by the principal investigator and study sponsor
  • Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm
  • Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm
  • Willing and competent to give written informed consent
  • Willing and able to complete all study assessments and follow-up requirements

Who cannot join

  • Distance between Proximal Radial Artery and Cubital Perforating Vein > 3 mm
  • Subject study extremity systolic blood pressure < 100mmHg Known central venous stenosis of > 50% ipsilateral to the study extremity
  • Any obstruction of superficial venous outflow from intended device implant site to the axillary vein
  • Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
  • Any previous dialysis vascular access procedures in the study extremity
  • History of access related hand ischemia from a previous hemodialysis vascular access of the non-study extremity which required intervention or access abandonment
Show all 25Show fewer
  • Upper extremity venous occlusion and/or vessel abnormality of the study extremity that precludes endovascular AVF creation as determined by principal investigator or study sponsor
  • Evidence of active systemic infections on day of the procedure or infection at the procedure access site within the past 7 days
  • History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
  • Any contraindication to antiplatelet therapy
  • Currently being treated with another investigational device or drug
  • Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
  • Uncontrolled or poorly controlled diabetes defined as a HbA1C > 10%
  • Known hypercoagulable condition, bleeding diathesis or coagulation disorder
  • Receiving anti-coagulant therapy that cannot be safely held in the peri-procedural period
  • Edema of the study extremity
  • Scheduled kidney transplant within 6 months of enrollment
  • Peripheral white blood cell count < 1,500 cells/microL or > 13,000 cells/microL and neutrophil > 80%
  • Platelet count < 75,000 cells/ microL
  • Serum procalcitonin level > 0.75 ng/mL for subjects with central venous catheters
  • Current diagnosis of carcinoma (unless in remission > 1 year)
  • Pregnant or currently breast feeding
  • History of substance abuse or anticipated to be non- compliant with medical care or study requirements based on investigator judgment
  • Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System
  • Any other medical condition that in the opinion of the investigator would put the welfare of the subject at risk or confound interpretation of the study data

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Trinity Research Group

    Dothan, Alabama, 36301

  • Texas Research Institute

    Fort Worth, Texas, 76104

  • American Access Care of Jacksonville

    Jacksonville, Florida, 32218

  • Apex Research

    Riverside, California, 92505

  • STAR Vascular

    San Antonio, Texas, 78207

Other trials in United States

About this study

Official title: Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System

The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.

Being tested
Velocity pAVF System
Keywords
Dialysis Access, Hemodialysis, AV Fistula, Percutaneous AVF
Medical subject headings
Kidney Failure, Chronic, Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Velocity pAVF SystemDevice

    Also called pAVF, endoAVF

    The Velocity Percutaneous Arterio-Venous Fistula System consists of a percutaneous method designed to create an arteriovenous fistula for hemodialysis vascular access.

Study groups in NCT06712251
Study groupRoleWhat they receive
Velocity Percutaneous Arterio-Venous Fistula SystemExperimentalNot described
Receives: Device: Velocity pAVF System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physiologic Maturation

    The proportion of participants that reach the binary outcome of Physiologic Maturation (mature/unmature). Physiologic Maturation is a composite measure, reached when Duplex ultrasound demonstrates a brachial artery blood flow of ≥ 500 ml/min and an outflow vein diameter of ≥ 5 mm.

    Measured: 6 weeks

  2. Serious Adverse Device Effect

    Any Serious Adverse Event that reasonably suggests is caused by the device or procedure

    Measured: 30 days

Secondary outcomes (12)

  1. Functional Maturation

    The number of participants with successful two needle cannulation for 75% of dialysis sessions over a consecutive 4 weeks period following pAVF creation

    Measured: 3 months

  2. Unassisted Functional Maturation

    The number of participants that reach functional maturation without any endovascular or surgical interventions to the pAVF to facilitate maturation and/or manage complications

    Measured: 3 months

  3. Time to First Hemodialysis

    The interval from the time of pAVF creation to the first hemodialysis session using 2-needles in the ESRD subgroup

    Measured: Up to 52 weeks

  4. Number of Catheter Days

    The number of days from pAVF creation to central venous catheter removal in the ESRD subgroup.

    Measured: Up to 52 weeks

  5. Total Reinterventions

    All reinterventions related to the access will be captured over the life of the access until abandonment or when the subject exits the study.

    Measured: 12 months

  6. Freedom from Reintervention

    The duration from the time of access creation until the first occurrence of a reintervention required to maintain or restore patency of the pAVF

    Measured: Up to 104 weeks

  7. Technical Success

    Intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein

    Measured: Day of study intervention

  8. Primary Patency

    The time of access creation until the first occurrence of any reintervention to maintain or reestablish patency or until access abandonment

    Measured: 6 months

  9. Primary Assisted Patency

    The time from access creation to the first reintervention to maintain patency, including reinterventions intended to prevent thrombosis or restenosis, without the occurrence of thrombosis or abandonment of the access

    Measured: 6 months

  10. Cumulative Patency

    The interval from the time of access creation or intervention until the final abandonment of the access, inclusive of all successful interventions to maintain or restore patency

    Measured: 6 months

  11. Freedom from Serious Adverse Events

    The time from access creation to the first occurrence of any serious adverse event (SAE)

    Measured: Up to 104 weeks

  12. Functional Patency

    Elapsed time from functional maturation to abandonment of the access site

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start8 Jan 2025
  3. Primary completion15 May 2025
  4. Study completion4 Jan 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06712251
Sponsor's protocol ID
CP0687
Acronym
VENOS-2
Status last verified
Aug 2025
First submitted
21 Nov 2024
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Velocity pAVF System in people with Chronic Kidney Disease Requiring Hemodialysis and End Stage Renal Disease (ESRD), run by Venova Medical at 5 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 6 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physiologic Maturation (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06712251.

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 17 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in