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

Launched by C. R. BARD · Nov 16, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the BD® WavelinQ™ EndoAVF System, which is a device used to create a special type of connection called an arteriovenous (AV) fistula. This connection is important for patients who need dialysis, a treatment for end-stage kidney disease, as it allows blood to flow easily during the process. The trial is looking for patients aged 18 and older who have serious kidney failure and are either already on dialysis or will need it soon. Participants should also have certain vein and artery sizes that meet specific criteria.

If you choose to participate, you will need to sign a consent form and agree to follow the study's guidelines, which include regular check-ups. The study is currently recruiting and is open to all genders. It's important to note that there are some health conditions that may prevent someone from participating, such as certain blood disorders or active infections. If eligible, you'll be contributing to research that could help improve treatment options for people with kidney disease.

Gender

ALL

Eligibility 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.