Clinical trial NCT05757726: Early Feasibility of the Velocity™ Percutaneous PAVF System
Official title: Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Fistula
Lead sponsor: Venova Medical
Sponsor class: INDUSTRY
First posted: 2023-03-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring hemodialysis vascular access.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Diagnosed with ESRD and currently on hemodialysis for less than 12 months using a central venous catheter for access
* Eligible for a native surgical brachiocephalic arteriovenous fistula following assessment by the principal investigator and study sponsor
* Cubital perforating vein diameter of \> 2.5 mm and length \> 10.0 mm
* Proximal radial artery diameter ≥ 2.0 mm
* Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure
* Willing and competent to give written informed consent

Exclusion Criteria:

* Distance between Proximal Radial Artery and Cubital Perforating vein \> 3mm
* Ipsilateral arm systolic blood pressure \< 110 mmHg
* Known central venous stenosis or central vein narrowing \> 50% ipsilateral to the study extremity
* Any obstruction of venous outflow from device implant site to the axillary vein
* Patients 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 steal syndrome (hand ischemia) from a previous hemodialysis vascular access of the non-study extremity which required intervention or access abandonment
* Upper extremity venous occlusion(s) and/or vessel abnormality(ies) 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 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
* 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%
* Hypercoagulable condition, bleeding diathesis or coagulation disorder
* Receiving anti-coagulant therapy that cannot be safely held in the peri-procedural period
* Edema of the upper arm of the study extremity
* Scheduled kidney transplant within 6 months of enrollment
* Peripheral white blood cell count \< 1.5 K/mm3 or platelet count \< 75,000 cells/mm3
* Current diagnosis of carcinoma (defined as 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 NiTi alloy or any of the components of the Velocity Implant or Delivery System
* Written informed consent not obtainable

Primary outcomes:
measure: Procedural Success
timeFrame: Immediate
measure: Serious Adverse Device Events
timeFrame: 6 weeks
measure: Major Reintervention
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Sanatorio Italiano
Study officials:
affiliation: Sanatorio Italiano
name: Adrian Ebner, MD
role: PRINCIPAL_INVESTIGATOR
References: