Velocity™ pAVF System for Dialysis Access
This study is testing the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new way to create an arteriovenous fistula (AVF) for hemodialysis access. An AVF is a connection between an artery and a vein, which is essential for dialysis in people with chronic kidney disease (CKD) or end-stage renal disease (ESRD). Unlike traditional surgery, the Velocity System creates the AVF through a small skin puncture using a catheter, aiming for a simpler procedure and better maturation. The study will enroll about 126 participants aged 18 to 80 who need dialysis access. Researchers will look at how well the AVF matures after 6 weeks and any serious problems within 30 days. The current status of the study is unclear.
- Study design
- This interventional study plans to enroll 126 participants to evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed to assess AVF maturation at 6 weeks and serious adverse events at 30 days.
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Pivotal Study of the Velocity™ pAVF System
At a glance
Conditions
Where it's being run
12 sites across 7 statesWho to contact
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What this trial measures
- Physiologic Maturation6 weeks
The proportion of participants that reach the binary outcome of Physiologic Maturation. Physiologic Maturation is a composite measure, reached when Duplex ultrasound demonstrates a brachial artery blood flow of ≥ 500 ml/min and an outflow vein diameter of ≥ 5 mm.
- Serious Adverse Device Effect30 days
Any Serious Adverse Event that reasonably suggests is caused by the device or procedure