RecruitingKidney Disease, End-StageEnd-stage Renal DiseaseArteriovenous Fistula

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

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

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.

Sponsor: C. R. Bard

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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).