VasQ External Support Implant for Dialysis Fistulas
This study is looking at a device called VasQ, which is an external support implant for arteriovenous fistulas (a connection made between an artery and a vein, usually in the arm, to create better access for dialysis). The goal is to see if using VasQ helps these fistulas work better for dialysis compared to the standard way of creating them. You might be able to join if you are between 18 and 80 years old, male or female, and need a new fistula created for dialysis. The study will measure how well the fistula works after 6 months. The current status of the study is unclear, but it plans to enroll 300 patients.
- Study design
- This is a multi-center, randomized study with 300 participants. You would be randomly assigned to either receive a fistula with VasQ support or a standard fistula.
- What's involved
- You would have a procedure to create an arteriovenous fistula. The primary endpoint is measured at 6 months after the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 12 months after the initial fistula creation procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
At a glance
Conditions
Where it's being run
9 sites across 9 statesStudy leadership
- John F Lucas III, MD FACS FSVS · PRINCIPAL_INVESTIGATOR · Greenwood Leflore Hospital
Who to contact
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What this trial measures
- Fistula functional success6 months
The time, in days, to the first day of a 28-day period in which the study fistula was able to be cannulated with two dialysis needles for at least 75% of dialysis sessions to achieve the prescribed dialysis