Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorC. R. Bard
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Known history of active intravenous drug abuse.
Trial design
Treatments tested in this trial
- EndoAVF Creation
Treatment groups
280 Participants
are divided into 1 treatment groupLocations
17Australia
Southern Adelaide Local Health Network5042, Bedford ParkSouth Australia, Australia
United States
California
California Institute of Renal Research92037, La Jolla United States
San Francisco Vein & Vascular94117, San Francisco United States
Florida
First Coast Cardiovascular Institute Pa32256, Jacksonville United States
Sponsors and collaborators
C. R. Bard
Lead sponsor
Source ClinicalTrials.gov