Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System (NCT04634916) | Clinical Trial Compass
RecruitingNot Applicable
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
United States280 participantsStarted 2021-03-26
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. The subject is in a hypercoagulable state.
✕. The subject has known bleeding diathesis.
✕. The subject has insufficient cardiac output to support a native fistula in the opinion of the Investigator.
What they're measuring
1
Functional Cannulation Success
Timeframe: 6-months post index procedure
2
Primary Patency
Timeframe: 6-months post index procedure
3
Device- and procedure-related serious adverse events (SAE)
✕. "Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure.
✕. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
✕. The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
✕. 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).