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Clinical Trials in Australia / NCT04634916
Recruiting Not applicable

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

NCT04634916 · tracked via the Priya Life Science Australia tracker
Sponsor
Phase
Not applicable
Started
2021-03-26
Last updated
2026-08-10

Condition(s) studied

Kidney Disease, End-StageEnd-stage Renal DiseaseArteriovenous Fistula

Investigational drug(s) / intervention(s)

EndoAVF Creation

EndoAVF Creation: Subjects will have an endoAVF created using the WavelinQ EndoAVF System

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
California Institute of Renal Research La Jolla California Recruiting
San Francisco Vein & Vascular San Francisco California Recruiting
First Coast Cardiovascular Institute Pa Jacksonville Florida Recruiting
Radiology and Imaging Specialists Lakeland Florida Recruiting
Vascular and Spine Institute Inc Miami Florida Active Not Recruiting
Kidney Care and Transplant Services of NE Springfield Massachusetts Recruiting
Kidney Care & Transplant Services of New England West Springfield Massachusetts Recruiting
UMass Chan School of Medicine Worcester Massachusetts Recruiting
Albany Medical Center Albany New York Recruiting
NC Nephrology Raleigh North Carolina Completed
ProMedica Toledo Hospital Toledo Ohio Recruiting
Butler Memorial Hospital Butler Pennsylvania Recruiting
Vascular Institute of Chattanooga Chattanooga Tennessee Recruiting
Bluff City Vascular Memphis Tennessee Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Houston Methodist Houston Texas Recruiting
Southern Adelaide Local Health Network Bedford Park South Australia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04634916 on ClinicalTrials.gov ↗ ← All trials in Australia