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Using the BD® WavelinQ™ EndoAVF System to create arteriovenous fistulas for dialysis patients

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

Not applicable Interventional C. R. Bard · NCT04634916

This study is testing a new device to see if it can safely create access points for dialysis in patients with severe kidney disease.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment280 (estimated)
Ages18 Years and up
SexAll
SponsorC. R. Bard Industry-sponsored
Locations17 sites (La Jolla, California and 16 other locations)
Trial IDNCT04634916 on ClinicalTrials.gov

What this trial studies

This study evaluates the BD® WavelinQ™ EndoAVF System, a device designed for the creation of arteriovenous fistulas in patients requiring dialysis due to end-stage kidney disease. It is a prospective, single-arm, multi-center post-market surveillance study that aims to gather data on the effectiveness and safety of this intervention. Participants will be monitored for their compliance with the protocol and clinical follow-up to assess outcomes related to the procedure. The study is conducted across multiple locations to ensure a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with established kidney failure who are currently on dialysis or in need of dialysis within six months.

Not a fit: Patients who do not require dialysis or have reversible kidney failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the creation of arteriovenous fistulas, leading to better dialysis access and outcomes for patients with kidney disease.

How similar studies have performed: While this approach is being evaluated in a post-market setting, similar interventions have shown promise in improving dialysis access in previous studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

La Jolla, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Kidney Disease, End-StageEnd-stage Renal DiseaseArteriovenous FistulaEndoAVF
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.