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

Venova Medical

Status

Enrolling

Conditions

Chronic Kidney Disease Requiring Hemodialysis

End Stage Renal Disease (ESRD)

Treatments

Device: Velocity pAVF System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06712251

CP0687

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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