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New treatment option for Chronic Kidney Disease
Official title Pivotal Study of the Velocity™ pAVF System
ClinicalTrials.gov ID: NCT07153939
What this study is testing
- What it's testing
- This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access. People with kidney failure often require dialysis, which depends on having a reliable arteriovenous fistula (AVF).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months
- Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm
- Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm
- Age \> 18 years and \< 80 years
- Willing and competent to give written informed consent
You likely can't join if
- Study extremity systolic blood pressure \< 100mmHg
- people with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
- people with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.
- Distance between Cubital Perforating Vein and Proximal Radial Artery \> 3.0 mm
- Cephalic vein diameter \< 2.5 mm at any point from the CPV to the axillary vein
- Central venous occlusion ipsilateral of the study extremity
See the full eligibility criteria
- ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months
- Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm
- Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm
- Age \> 18 years and \< 80 years
- Willing and competent to give written informed consent
- Willing and able to complete all study assessments and follow-up requirements
- Study extremity systolic blood pressure \< 100mmHg
- people with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
- people with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.
- Distance between Cubital Perforating Vein and Proximal Radial Artery \> 3.0 mm
- Cephalic vein diameter \< 2.5 mm at any point from the CPV to the axillary vein
- Central venous occlusion ipsilateral of the study extremity
- Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.
- Evidence of active systemic infections or localized to 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...
- 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
- Lymphedema of the study extremity
- Scheduled kidney transplant within 6 months of enrollment
- Peripheral white blood cell count \ 13,000 cells/μL and neutrophil \> 80%
- Platelet count \< 75,000 cells/ μL
- Current diagnosis of carcinoma (unless in remission \> 1 year)
- Pregnant or currently breast feeding
- 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
- Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Concord, California, United States
- Riverside, California, United States
- Cocoa, Florida, United States
- Jacksonville, Florida, United States
- Staten Island, New York, United States
- Charlotte, North Carolina, United States
- Orangeburg, South Carolina, United States
- Houston, Texas, United States
- Humble, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Concord, California, United States; Riverside, California, United States; Cocoa, Florida, United States; Jacksonville, Florida, United States; Staten Island, New York, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.