ACTIVE_NOT_RECRUITING

Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access

Conditions

Chronic Kidney Disease Requiring Hemodialysis End Stage Renal Disease (ESRD)Dialysis Access Hemodialysis AV Fistula Percutaneous AVF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-08

Study Completion:2027-01-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06712251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

Trinity Research Group

Dothan, Alabama, 36301

United States

Apex Research

Riverside, California, 92505

United States

American Access Care of Jacksonville

Jacksonville, Florida, 32218

United States

Texas Research Institute

Fort Worth, Texas, 76104

United States

STAR Vascular

San Antonio, Texas, 78207

United States

Collaborators and Investigators

Sponsor: Venova Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-08

Study Completion Date2027-01-04

Study Record Updates

Study Start Date2025-01-08

Study Completion Date2027-01-04

Terms related to this study

Keywords Provided by Researchers

Dialysis Access
Hemodialysis
AV Fistula
Percutaneous AVF

Additional Relevant MeSH Terms

Chronic Kidney Disease Requiring Hemodialysis
End Stage Renal Disease (ESRD)