Arteriovenous Fistula, Chronic Kidney Disease, End Stage Renal Disease (ESRD), Hemodialysis Access
Conditions
Keywords
percutaneous AVF, pAVF, endovascular AVF, endoAVF, Arteriovenous Fistula, AVF, VENOS-3, VENOS3
Brief summary
This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access. People with kidney failure often require dialysis, which depends on having a reliable arteriovenous fistula (AVF). Traditionally, AVFs are created with surgery, but surgery can involve incisions, longer recovery, and sometimes additional procedures before the AVF can be used. The Velocity System is designed to create an AVF through a small puncture in the skin using a catheter-based approach, without open surgery. This pivotal study will assess how safe the procedure is and how well it works for patients who need dialysis. The study will take place at multiple centers in the United States and will enroll adults with kidney failure who are candidates for fistula creation. Participants will undergo the Velocity procedure and then be followed closely with exams, ultrasounds, and dialysis assessments for up to five years. Taking part is voluntary. Patients may benefit from a less invasive approach to dialysis access, but the main goal is to collect information that could improve future care for people with kidney failure.
Interventions
DEVICEVelocity Percutaneous Arteriovenous Fistula
The Velocity pAVF is a catheter-based device used to create an arteriovenous fistula for hemodialysis access through a minimally invasive, percutaneous procedure. Unlike surgical AVF creation or other pAVF systems, Velocity is designed to simplify the procedure and improve consistency of maturation and long-term function. All participants in this study will undergo AVF creation using the Velocity pAVF.
Sponsors
Venova Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months 2. Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm 3. Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm 4. Age \> 18 years and \< 80 years 5. Willing and competent to give written informed consent 6. Willing and able to complete all study assessments and follow-up requirements
Exclusion criteria
1. Study extremity systolic blood pressure \< 100mmHg 2. Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test 3. Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF. 4. Distance between Cubital Perforating Vein and Proximal Radial Artery \> 3.0 mm 5. Cephalic vein diameter \< 2.5 mm at any point from the CPV to the axillary vein 6. Central venous occlusion ipsilateral of the study extremity 7. Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment. 8. Evidence of active systemic infections or localized to the procedure access site within the past 7 days 9. 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 10. Any contraindication to antiplatelet therapy 11. Currently being treated with another investigational device or drug 12. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated 13. Uncontrolled or poorly controlled diabetes defined as a HbA1C \> 10% 14. Known hypercoagulable condition, bleeding diathesis or coagulation disorder 15. Lymphedema of the study extremity 16. Scheduled kidney transplant within 6 months of enrollment 17. Peripheral white blood cell count \< 1,500 cells/μL or \> 13,000 cells/μL and neutrophil \> 80% 18. Platelet count \< 75,000 cells/ μL 19. Current diagnosis of carcinoma (unless in remission \> 1 year) 20. Pregnant or currently breast feeding 21. Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System 22. 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 23. Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Device Effect | 30 days | Any Serious Adverse Event that reasonably suggests is caused by the device or procedure |
| Physiologic Maturation | 6 weeks | The proportion of participants that reach the binary outcome of Physiologic Maturation. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Velocity pAVF Primary Patency | Assessed up to 5 years | The interval of time from access creation until the first occurrence of reintervention or thrombosis directly attributable to a causative lesion within 5 mm of each end of the Velocity pAVF. |
| Access Circuit Cumulative Patency | Assessed up to 5 years | The interval of time from access creation until the final abandonment of the access, inclusive of all successful interventions to maintain or restore patency |
| Technical Success | Immediately after the intervention | The proportion of subjects with successful delivery of the implant between the perforating cubital vein and the radial artery, and removal of the delivery system, at the index procedure. |
| Procedural Success | Immediately after the intervention | The proportion of subjects with intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein |
| Freedom from Reintervention | Assessed up to 5 years | The duration from the time of access creation until the first occurrence of a reintervention required to maintain or restore patency of the pAVF |
| Total Reinterventions | Assessed up to 5 years | The total number of reinterventions over the life of the access until abandonment or when the subject exits the study. |
| Freedom from Serious Adverse Events | Assessed up to 5 years | Defined as the interval of time from access creation to the first occurrence of any serious adverse event. |
| Time to First Hemodialysis | Through 12 month follow up, on average at 3 months | The interval from the time of pAVF creation to the first hemodialysis session using 2-needles in the ESRD subgroup |
| Functional Maturation | 6 months | The number of participants with successful two needle cannulation for 75% of dialysis sessions over a consecutive 4 weeks period following pAVF creation |
| Unassisted Functional Maturation | 6 months | The number of participants that reach functional maturation without any endovascular or surgical interventions to facilitate maturation and/or manage complications |
| Number of Catheter Days | Through 12 month follow up, on average at 3 months | The number of days from pAVF creation to central venous catheter removal in the ESRD subgroup. |
| Physiologic Maturation | 3 months | The proportion of participants that reach the binary outcome of Physiologic Maturation. 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. |
| Access Circuit Primary Patency | Assessed up to 5 years | The interval of time from access creation until the first occurrence of any reintervention to maintain or reestablish patency or until access thrombosis or abandonment. |
Countries
United States
Contacts
CONTACTShant Vartanian, MD
Outcome results
None listed