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

Venova Medical5 sites in 1 country20 target enrollmentJanuary 8, 2025

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Venova Medical
Enrollment: 20
Locations: 5
Primary Endpoint: Physiologic Maturation
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 8, 2025

End Date

January 4, 2027

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Venova Medical

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Physiologic Maturation

Time Frame: 6 weeks

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.

Serious Adverse Device Effect

Time Frame: 30 days

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