Clinical trial NCT06712251: Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access
Official title: Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Requiring Hemodialysis
End Stage Renal Disease (ESRD)
Keywords: Dialysis Access
Hemodialysis
AV Fistula
Percutaneous AVF
Lead sponsor: Venova Medical
Sponsor class: INDUSTRY
First posted: 2024-12-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Physiologic Maturation
timeFrame: 6 weeks
measure: Serious Adverse Device Effect
timeFrame: 30 days
Secondary outcomes:
measure: Functional Maturation
timeFrame: 3 months
measure: Unassisted Functional Maturation
timeFrame: 3 months
measure: Time to First Hemodialysis
timeFrame: Up to 52 weeks
measure: Number of Catheter Days
timeFrame: Up to 52 weeks
measure: Total Reinterventions
timeFrame: 12 months
measure: Freedom from Reintervention
timeFrame: Up to 104 weeks
measure: Technical Success
timeFrame: Day of study intervention
measure: Primary Patency
timeFrame: 6 months
measure: Primary Assisted Patency
timeFrame: 6 months
measure: Cumulative Patency
timeFrame: 6 months
measure: Freedom from Serious Adverse Events
timeFrame: Up to 104 weeks
measure: Functional Patency
timeFrame: 12 months
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trinity Research Group
state: Alabama
city: Riverside
country: United States
facility: Apex Research
state: California
city: Jacksonville
country: United States
facility: American Access Care of Jacksonville
state: Florida
city: Fort Worth
country: United States
facility: Texas Research Institute
state: Texas
city: San Antonio
country: United States
facility: STAR Vascular
state: Texas
Study officials:
References: