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RECRUITINGNA

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

NCT04634916•C. R. Bard

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject must be either male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
•2. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
•3. Subject must be willing to comply with the protocol requirements, including clinical follow-up.
•4. Subjects who have established, non-reversible kidney failure, who are currently on dialysis at screening or are in immediate need (within 6 months of endoAVF creation) of dialysis.
•5. Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Venography.
•6. Target treatment artery diameter ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Arteriogram.
•7. Subject has adequate collateral circulation to the hand, in the opinion of the Investigator.
•8. At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein.

Exclusion Criteria

•1. The subject is in a hypercoagulable state.
•2. The subject has known bleeding diathesis.
•3. The subject has insufficient cardiac output to support a native fistula in the opinion of the Investigator.
•4. Known history of active intravenous drug abuse.
•5. "Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure.
•6. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
•7. The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
•8. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected).
•9. The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
•10. The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.
+5 more criteria

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

Key Dates

Start Date

March 26, 2021

Primary Completion Date

June 1, 2027

Completion Date

September 1, 2027

Last Updated

March 18, 2026

Enrollment

280

ESTIMATED participants

Conditions

Kidney Disease, End-StageEnd-stage Renal DiseaseArteriovenous Fistula

Interventions

EndoAVF Creation

DEVICE

Contacts

Lindsay Downing

CONTACT

804-307-0924 lindsay.downing@bd.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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