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NCT04634916NARecruiting

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

C. R. Bard

Start Date

3/26/2021

Completion Date

9/1/2027

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 Criteria

Age Range: 18 years to No maximum

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. 11. The subject has central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned endoAVF creation. 12. Absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via Duplex Ultrasound (DUS) or Venography. 13. Occlusion or stenosis \> 50% of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via Duplex Ultrasound (DUS) or Venography. 14. Significantly compromised venous or arterial flow in the treatment arm as determined by Investigator and Duplex Ultrasound (DUS) or Venography. 15. Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the Investigator.

Interventions

DEVICE

EndoAVF Creation

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Conditions

Kidney Disease, End-StageEnd-stage Renal DiseaseArteriovenous Fistula

Locations

California Institute of Renal Research

La Jolla, California 92037

United States

San Francisco Vein & Vascular

San Francisco, California 94117

United States

First Coast Cardiovascular Institute Pa

Jacksonville, Florida 32256

United States

Radiology and Imaging Specialists

Lakeland, Florida 33801

United States

Vascular and Spine Institute Inc

Miami, Florida 33156

United States

Kidney Care and Transplant Services of NE

Springfield, Massachusetts 01089

United States

Kidney Care & Transplant Services of New England

West Springfield, Massachusetts 01089

United States

UMass Chan School of Medicine

Worcester, Massachusetts 01655

United States

Albany Medical Center

Albany, New York 12208

United States

NC Nephrology

Raleigh, North Carolina 27609

United States

ProMedica Toledo Hospital

Toledo, Ohio 43606

United States

Butler Memorial Hospital

Butler, Pennsylvania 16001

United States

Vascular Institute of Chattanooga

Chattanooga, Tennessee 37421

United States

Bluff City Vascular

Memphis, Tennessee 38104

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Houston Methodist

Houston, Texas 77030

United States

Southern Adelaide Local Health Network

Bedford Park, South Australia 5042

Australia