Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access (VENOS-2)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: End Stage Renal Disease (ESRD); Chronic Kidney Disease Requiring Hemodialysis
• Intervention / Treatment: Device: Velocity pAVF System

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Trinity Research Group
  • California
    • Riverside, California, United States, 92505
      • Apex Research
  • Florida
    • Jacksonville, Florida, United States, 32218
      • American Access Care of Jacksonville
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Texas Research Institute
    • San Antonio, Texas, United States, 78207
      • STAR Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Velocity Percutaneous Arterio-Venous Fistula System	Device: Velocity pAVF System; The Velocity Percutaneous Arterio-Venous Fistula System consists of a percutaneous method designed to create an arteriovenous fistula for hemodialysis vascular access.; Other Names: pAVF; endoAVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
Serious Adverse Device Effect	Any Serious Adverse Event that reasonably suggests is caused by the device or procedure	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
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	3 months
Time to First Hemodialysis	The interval from the time of pAVF creation to the first hemodialysis session using 2-needles in the ESRD subgroup	Up to 52 weeks
Number of Catheter Days	The number of days from pAVF creation to central venous catheter removal in the ESRD subgroup.	Up to 52 weeks
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.	12 months
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	Up to 104 weeks
Technical Success	Intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein	Day of study intervention
Primary Patency	The time of access creation until the first occurrence of any reintervention to maintain or reestablish patency or until access abandonment	6 months
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	6 months
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	6 months
Freedom from Serious Adverse Events	The time from access creation to the first occurrence of any serious adverse event (SAE)	Up to 104 weeks
Functional Patency	Elapsed time from functional maturation to abandonment of the access site	12 months

Collaborators and Investigators

• Sponsor: Venova Medical

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Actual): May 15, 2025
• Study Completion (Estimated): January 4, 2027

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Hemodialysis; AV Fistula; Dialysis Access; Percutaneous AVF
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: CP0687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No