NCT06712251Active, not recruitingNot Applicable
Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
Venova Medical10 sites in 1 country20 target enrollmentStarted: January 8, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 10
- Primary Endpoint
- Physiologic Maturation
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Secondary Outcomes
- Functional Patency(12 months)
- 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)
- Freedom from Reintervention(Up to 104 weeks)
- Technical Success(Day of study intervention)
- Primary Patency(6 months)
- Primary Assisted Patency(6 months)
- Cumulative Patency(6 months)
- Freedom from Serious Adverse Events(Up to 104 weeks)
Investigators
Study Sites (10)
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