A Prospective, Multi-Center Clinical Study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis
C. R. Bard
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 dial…
Interventions
- DeviceEndoAVF Creation
Subjects will have an endoAVF created using the WavelinQ EndoAVF System
Locations (17)
- California Institute of Renal ResearchLa Jolla, California
- San Francisco Vein & VascularSan Francisco, California
- First Coast Cardiovascular Institute PaJacksonville, Florida
- Radiology and Imaging SpecialistsLakeland, Florida
- Vascular and Spine Institute IncMiami, Florida
- Kidney Care and Transplant Services of NESpringfield, Massachusetts