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

NCT06712251 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CP0687
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chronic Kidney Disease Requiring Hemodialysis; End Stage Renal Disease (ESRD)

Keywords

Dialysis Access; Hemodialysis; AV Fistula; Percutaneous AVF

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Functional Maturation

  3 months

• Unassisted Functional Maturation

  3 months

• Time to First Hemodialysis

  Up to 52 weeks

• Number of Catheter Days

  Up to 52 weeks

• Total Reinterventions

  12 months

Study Arms (1)

Velocity Percutaneous Arterio-Venous Fistula System

EXPERIMENTAL

Device: Velocity pAVF System

Interventions

Velocity pAVF System DEVICE

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

Also known as: pAVF, endoAVF

Velocity Percutaneous Arterio-Venous Fistula System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Venova Medical: lead

Study Sites (5)

Trinity Research Group

Dothan, Alabama, 36301, United States

Location

Apex Research

Riverside, California, 92505, United States

Location

American Access Care of Jacksonville

Jacksonville, Florida, 32218, United States

Location

Texas Research Institute

Fort Worth, Texas, 76104, United States

Location

STAR Vascular

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 2, 2024
• Study Start: January 8, 2025
• Primary Completion: May 15, 2025
• Study Completion (Estimated): January 4, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (5)