Early Feasibility of the Velocity™ Percutaneous PAVF System (VENOS-1)

Venova Medical

Status

Completed

Conditions

Arteriovenous Fistula

Treatments

Device: Velocity pAVF system

Study type

Interventional

Funder types

Industry

Identifiers

NCT05757726

CP0251.A

Details and patient eligibility

About

An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring hemodialysis vascular access.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years or older
Diagnosed with ESRD and currently on hemodialysis for less than 12 months using a central venous catheter for access
Eligible for a native surgical brachiocephalic arteriovenous fistula following assessment by the principal investigator and study sponsor
Cubital perforating vein diameter of > 2.5 mm and length > 10.0 mm
Proximal radial artery diameter ≥ 2.0 mm
Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure
Willing and competent to give written informed consent

Exclusion criteria

Distance between Proximal Radial Artery and Cubital Perforating vein > 3mm
Ipsilateral arm systolic blood pressure < 110 mmHg
Known central venous stenosis or central vein narrowing > 50% ipsilateral to the study extremity
Any obstruction of venous outflow from device implant site to the axillary vein
Patients 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 steal syndrome (hand ischemia) from a previous hemodialysis vascular access of the non-study extremity which required intervention or access abandonment
Upper extremity venous occlusion(s) and/or vessel abnormality(ies) 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 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
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%
Hypercoagulable condition, bleeding diathesis or coagulation disorder
Receiving anti-coagulant therapy that cannot be safely held in the peri-procedural period
Edema of the upper arm of the study extremity
Scheduled kidney transplant within 6 months of enrollment
Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3
Current diagnosis of carcinoma (defined as 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 NiTi alloy or any of the components of the Velocity Implant or Delivery System
Written informed consent not obtainable