RecruitingNot ApplicableNCT06516653

Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula

Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.


Sponsor

Laminate Medical Technologies

Enrollment

300 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is following patients who receive a small surgical implant called VasQ — a device that wraps around the outside of a newly created arteriovenous (AV) fistula (a surgically made connection between an artery and vein in the arm used for dialysis). The goal is to see how well the fistula functions over time when supported by this device. **You may be eligible if...** - You are 18–80 years old - You need dialysis and are having a new AV fistula created in your wrist or upper arm (radiocephalic or brachiocephalic fistula) - You are male, or a female who is not pregnant - You are able and willing to attend follow-up visits over 12 months **You may NOT be eligible if...** - The surgery is a revision of an existing fistula (not a brand-new one) - The target vein has significant narrowing (50% or more) that would affect outcomes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEVasQ

External support implant for the arteriovenous fistula

PROCEDUREArteriovenous fistula creation for dialysis vascular access

End to side fistula creation in the arm for dialysis vascular access


Locations(7)

Fresenius Vascular Care Long Beach

Long Beach, California, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Greenwood Leflore Hospital

Greenwood, Mississippi, United States

Azura Surgery Center Las Vegas

Las Vegas, Nevada, United States

Fresenius Vascular Care Columbia

Columbia, South Carolina, United States

Fairlawn Surgery Center

Roanoke, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06516653


Related Trials