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

Launched by VENOVA MEDICAL · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new device called the Velocity Percutaneous Arterio-Venous Fistula System. It offers a less invasive way to create a connection between an artery and a vein, which is important for patients who need hemodialysis due to chronic kidney disease or end-stage renal disease. The goal of the study is to gather information on how well the device works and to check its safety for patients.

To be eligible for this trial, participants need to be adults aged between 21 and 74 years who have advanced kidney disease and are suitable for a certain type of vascular access procedure. Key requirements include having specific sizes of blood vessels in their arm and being able to give consent and follow study procedures. Participants can expect to have regular assessments and follow-ups to monitor their progress. It's important to note that there are certain health conditions and factors that might prevent someone from joining this study, such as severe heart issues or active infections. Overall, this trial aims to improve the way patients receive hemodialysis through innovative technology.

Gender

ALL

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
• • 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