VENOS-1: Early Feasibility of the Velocity™ Percutaneous pAVF System

Sponsor

Venova Medical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05757726

Collaborator

(none)

Enrollment

Location

Arm

14.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arteriovenous Fistula	Device: Velocity pAVF system	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System

Actual Study Start Date :

Feb 14, 2023

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional Arm	Device: Velocity pAVF system A second generation percutaneous AVF device that creates an AVF between the proximal radial artery and cubital perforating vein.

Arm

Intervention/Treatment

Experimental: Interventional Arm

Device: Velocity pAVF system

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

Outcome Measures

Primary Outcome Measures

Procedural Success [Immediate]
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
Serious Adverse Device Events [6 weeks]
Defined as any Serious Adverse Event that reasonably suggests is caused by the device or procedure.
Major Reintervention [6 weeks]
Defined as any open surgery, thrombectomy or thrombolysis in the index limb following pAVF creation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanatorio Italiano	Asunción		Paraguay

Sponsors and Collaborators

Venova Medical

Investigators

Principal Investigator: Adrian Ebner, MD, Sanatorio Italiano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Venova Medical

ClinicalTrials.gov Identifier:

NCT05757726

Other Study ID Numbers:

CP0251.A

First Posted:

Mar 7, 2023

Last Update Posted:

Mar 7, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Arteriovenous Fistula

Fistula

Study Results

No Results Posted as of Mar 7, 2023