Tests a device for creating dialysis access in people with kidney failure

Trial details

Who runs it

C. R. Bard

Trial code

NCT04634916

Record updated

10 August 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: "Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure; 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 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; The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated; 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; 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 is in a hypercoagulable state; The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated; 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.

ClinicalTrials.gov NCT04634916