Pivotal Study of the Velocity™ pAVF System

Venova Medical126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Chronic Kidney Disease Hemodialysis Access

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (10)

Trinity Research Group

Dothan, Alabama, United States

RECRUITING

West Coast Kidney Institute Concord

Concord, California, United States

RECRUITING

Apex Research

Riverside, California, United States

RECRUITING

Vascular and Embolization Specialists

Cocoa, Florida, United States

RECRUITING

Azura Vascular Care Jacksonville

Jacksonville, Florida, United States

RECRUITING

Surgical Specialists of Charlotte

Charlotte, North Carolina, United States

RECRUITING

Aqua Research

Houston, Texas, United States

RECRUITING

Humble Vascular Surgical Center

Humble, Texas, United States

RECRUITING

Fresenius Vascular Care San Antonio

San Antonio, Texas, United States

RECRUITING

San Antonio Surgical Center

San Antonio, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Physiologic Maturation

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.

Time frame: 6 weeks

Serious Adverse Device Effect

Any Serious Adverse Event that reasonably suggests is caused by the device or procedure

Time frame: 30 days

Secondary Outcomes

Functional Maturation

The number of participants with successful two needle cannulation for 75% of dialysis sessions over a consecutive 4 weeks period following pAVF creation

Time frame: 6 months

Unassisted Functional Maturation

The number of participants that reach functional maturation without any endovascular or surgical interventions to facilitate maturation and/or manage complications

Time frame: 6 months

Physiologic Maturation

Time frame: 3 months

Time to First Hemodialysis

The interval from the time of pAVF creation to the first hemodialysis session using 2-needles in the ESRD subgroup

Time frame: Through 12 month follow up, on average at 3 months

Number of Catheter Days

The number of days from pAVF creation to central venous catheter removal in the ESRD subgroup.

Time frame: Through 12 month follow up, on average at 3 months

Access Circuit Primary Patency

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.

Time frame: Assessed up to 5 years

Velocity pAVF Primary Patency

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.

Time frame: Assessed up to 5 years

Access Circuit Cumulative Patency

The interval of time from access creation until the final abandonment of the access, inclusive of all successful interventions to maintain or restore patency

Time frame: Assessed up to 5 years

Technical Success

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.

Time frame: Immediately after the intervention

Procedural Success

The proportion of subjects with intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein

Time frame: Immediately after the intervention

Freedom from Reintervention

The duration from the time of access creation until the first occurrence of a reintervention required to maintain or restore patency of the pAVF

Time frame: Assessed up to 5 years

Total Reinterventions

The total number of reinterventions over the life of the access until abandonment or when the subject exits the study.

Time frame: Assessed up to 5 years

Freedom from Serious Adverse Events

Defined as the interval of time from access creation to the first occurrence of any serious adverse event.

Time frame: Assessed up to 5 years

Pivotal Study of the Velocity™ pAVF System

Overview

Conditions

Interventions

Eligibility

Locations (10)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts