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

Recruiting now · Not applicable

Conditions studied: Kidney Disease, End-Stage, End-stage Renal Disease, Arteriovenous Fistula

In brief

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.

Key facts

Study ID

NCT04634916

Run by

C. R. Bard

People needed

220

Starts

2021-03-26

Expected to finish

2027-09-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
• Subject must be willing to comply with the protocol requirements, including clinical follow-up.
• 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.
• Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Venography.
• Target treatment artery diameter ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Arteriogram.
• Subject has adequate collateral circulation to the hand, in the opinion of the Investigator.
• At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein.

You may not qualify if…

• The subject is in a hypercoagulable state.
• The subject has known bleeding diathesis.
• The subject has insufficient cardiac output to support a native fistula in the opinion of the Investigator.
• Known history of active intravenous drug abuse.
• "Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure.
• The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
• The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
• 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).
• 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.
• 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.
• The subject has central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned endoAVF creation.
• Absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via Duplex Ultrasound (DUS) or Venography.
• Occlusion or stenosis > 50% of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via Duplex Ultrasound (DUS) or Venography.
• Significantly compromised venous or arterial flow in the treatment arm as determined by Investigator and Duplex Ultrasound (DUS) or Venography.
• Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the Investigator.

Where it is running

• Southern Adelaide Local Health Network — Bedford Park, South Australia, Australia (enrolling)
• San Francisco Vein & Vascular — San Francisco, California, United States (enrolling)
• First Coast Cardiovascular Institute Pa — Jacksonville, Florida, United States (enrolling)
• Radiology and Imaging Specialists — Lakeland, Florida, United States (enrolling)
• Houston Methodist — Houston, Texas, United States (enrolling)
• California Institute of Renal Research — La Jolla, California, United States (enrolling)
• Kidney Care and Transplant Services of NE — Springfield, Massachusetts, United States (enrolling)
• Kidney Care & Transplant Services of New England — West Springfield, Massachusetts, United States (enrolling)
• UMass Chan School of Medicine — Worcester, Massachusetts, United States (enrolling)
• Albany Medical Center — Albany, New York, United States (enrolling)
• ProMedica Toledo Hospital — Toledo, Ohio, United States (enrolling)
• Butler Memorial Hospital — Butler, Pennsylvania, United States (enrolling)
• Vascular Institute of Chattanooga — Chattanooga, Tennessee, United States (enrolling)
• Bluff City Vascular — Memphis, Tennessee, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Vascular and Spine Institute Inc — Miami, Florida, United States
• NC Nephrology — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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