RecruitingNot ApplicableNCT04634916

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

A Prospective, Multi-Center Clinical Study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis

Sponsor

C. R. Bard

Enrollment

280 participants

Start Date

Mar 26, 2021

Study Type

INTERVENTIONAL

Conditions

Kidney Disease, End-Stage

Summary

A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This post-market surveillance study is collecting real-world outcomes from patients who have received the BD WavelinQ EndoAVF system — a minimally invasive procedure that creates an internal fistula (a connection between an artery and vein) in the forearm to allow dialysis access, avoiding the need for a catheter. **You may be eligible if...** - You are 18 or older, male or female (non-pregnant) - You have established, irreversible kidney failure and are on dialysis or about to start within 6 months - Your forearm blood vessels are large enough to support fistula creation - You are willing to attend follow-up visits **You may NOT be eligible if...** - You have a blood clotting disorder or active IV drug abuse - Your heart cannot support a fistula - You are scheduled for major surgery within 6 months after the procedure - Your blood vessels are too small or not suitable for the procedure 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.

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Interventions

DEVICEEndoAVF Creation

Subjects will have an endoAVF created using the WavelinQ EndoAVF System

Locations(17)

California Institute of Renal Research

La Jolla, California, United States

San Francisco Vein & Vascular

San Francisco, California, United States

First Coast Cardiovascular Institute Pa

Jacksonville, Florida, United States

Radiology and Imaging Specialists

Lakeland, Florida, United States

Vascular and Spine Institute Inc

Miami, Florida, United States

Kidney Care and Transplant Services of NE

Springfield, Massachusetts, United States

Kidney Care & Transplant Services of New England

West Springfield, Massachusetts, United States

UMass Chan School of Medicine

Worcester, Massachusetts, United States

Albany Medical Center

Albany, New York, United States

NC Nephrology

Raleigh, North Carolina, United States

ProMedica Toledo Hospital

Toledo, Ohio, United States

Butler Memorial Hospital

Butler, Pennsylvania, United States

Vascular Institute of Chattanooga

Chattanooga, Tennessee, United States

Bluff City Vascular

Memphis, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist

Houston, Texas, United States

Southern Adelaide Local Health Network

Bedford Park, South Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT04634916

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