Early Feasibility of the Velocity™ Percutaneous PAVF System

NCT05757726 | Completed FDA Device

• 1 other identifier: CP0251.A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Fistula

Outcome Measures

Primary Outcomes (3)

• Procedural Success

  Defined as Velocity deployment and delivery system withdrawal with intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein 2 cm central from the pAVF anastomosis

  Immediate

• Serious Adverse Device Events

  Defined as any Serious Adverse Event that reasonably suggests is caused by the device or procedure.

  6 weeks

• Major Reintervention

  Defined as any open surgery, thrombectomy or thrombolysis in the index limb following pAVF creation.

  6 weeks

Study Arms (1)

Interventional Arm

EXPERIMENTAL

Device: Velocity pAVF system

Interventions

Velocity pAVF system DEVICE

A second generation percutaneous AVF device that creates an AVF between the proximal radial artery and cubital perforating vein.

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Venova Medical: lead

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian Ebner, MD

  Sanatorio Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 7, 2023
• Study Start: February 14, 2023
• Primary Completion: November 15, 2023
• Study Completion: October 8, 2024
• Last Updated: March 19, 2025

Record last verified: 2024-10

Locations

PA (1)