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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• California Institute of Renal Research
  La Jolla, California, United States Recruiting
• San Francisco Vein & Vascular
  San Francisco, California, United States Recruiting
• First Coast Cardiovascular Institute Pa
  Jacksonville, Florida, United States Recruiting
• Radiology and Imaging Specialists
  Lakeland, Florida, United States Recruiting
• Kidney Care and Transplant Services of NE
  Springfield, Massachusetts, United States Recruiting
• Kidney Care & Transplant Services of New England
  West Springfield, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Eric Peden, MD — The Methodist Hospital Research Institute
• Study coordinator: Crystal Anderson
• Email: Crystal.Anderson@bd.com
• Phone: +16028305413

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.