Minimally invasive method for creating hemodialysis access
Official title: Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
Run by Venova Medical · NCT06712251 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new, less invasive method to create access for hemodialysis in people with chronic kidney disease or end-stage renal disease to see how well it works and if it's safe.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Venova Medical Industry-sponsored |
| Locations | 5 sites (Dothan, Alabama and 4 other locations) |
| Trial ID | NCT06712251 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with stage 4 or 5 chronic kidney disease or end-stage renal disease who meet specific vascular criteria for the procedure.
✕Probably not a fit
Patients with significant vascular obstructions or previous dialysis access procedures in the study extremity may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the Velocity Percutaneous Arterio-Venous Fistula System, a new minimally invasive technique designed to create vascular access for hemodialysis in patients with chronic kidney disease or end-stage renal disease. The primary focus is to assess the clinical efficacy and initial safety of this device. Eligible participants will undergo the procedure, and their outcomes will be monitored to gather data on the device's performance and safety profile.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective method for establishing hemodialysis access, improving patient outcomes.
How similar studies have gone: While this approach is innovative, similar minimally invasive techniques have shown promise in other studies, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Trinity Research Group
Dothan, Alabama, United States Recruiting -
Apex Research
Riverside, California, United States Recruiting -
American Access Care of Jacksonville
Jacksonville, Florida, United States Recruiting -
Texas Research Institute
Fort Worth, Texas, United States Recruiting -
STAR Vascular
San Antonio, Texas, United States Recruiting
Study contacts
- Study coordinator: Shant Vartanian, MD
- Email: venos-2@venovamed.com
- Phone: 408-242-5897
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.