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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
EndoAVF Creation
DeviceSubjects will have an endoAVF created using the WavelinQ EndoAVF System
Treatment groups
220 Participants
are divided into 1 treatment groupGroup A: EndoAVFExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Functional Cannulation Success
The percentage of subjects dialyzed using successful 2-needle access of the endoAVF for at least 75% of dialysis sessions over a continuous 28-day period
Time frame
6-months post index procedure2
Primary Patency
Subjects maintaining primary patency of the endoAVF
Time frame
6-months post index procedure3
Device- and procedure-related serious adverse events (SAE)
Freedom from device-related or procedure-related SAEs
Time frame
30-days post index procedureSecondary outcomes
1
Physiological Maturation
Defined by duplex ultrasound flow in the brachial artery of at least 500ml/min and outflow vein diameter ≥ 4mm
Time frame
2-weeks, 6-weeks, 6-months, and 24-months post index procedure2
Functional Maturation
Successful prescribed dialysis with 2-needle cannulation of the endoAVF for three continuous weeks
Time frame
6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure3
Procedure Success
Successful endoAVF creation
Time frame
Index procedure4
Cannulation Success
Successful 2-needle endoAVF cannulation
Time frame
6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure Source ClinicalTrials.gov