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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Subjects will have an endoAVF created using the WavelinQ EndoAVF System
California Institute of Renal Research
La Jolla, California, United States
RECRUITINGSan Francisco Vein & Vascular
San Francisco, California, United States
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 procedure
Primary Patency
Subjects maintaining primary patency of the endoAVF
Time frame: 6-months post index procedure
Device- and procedure-related serious adverse events (SAE)
Freedom from device-related or procedure-related SAEs
Time frame: 30-days post index procedure
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 procedure
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 procedure
Procedure Success
Successful endoAVF creation
Time frame: Index procedure
Cannulation Success
Successful 2-needle endoAVF cannulation
Time frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Primary Patency
Subjects maintaining primary patency of the endoAVF
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Radiology and Imaging Specialists
Lakeland, Florida, United States
RECRUITINGVascular and Interventional Specialists
Miami, Florida, United States
RECRUITINGUMass Chan School of Medicine
Worcester, Massachusetts, United States
RECRUITINGSSM St. Mary's
St Louis, Missouri, United States
COMPLETEDAlbany Medical Center
Albany, New York, United States
RECRUITINGSUNY Upstate Medical University Hospital
Syracuse, New York, United States
TERMINATEDNC Nephrology
Raleigh, North Carolina, United States
RECRUITINGButler Memorial Hospital
Butler, Pennsylvania, United States
RECRUITING...and 4 more locations
Time frame: 6-weeks, 3-, 12-, 18-, and 24-months post index procedure
Assisted Primary Patency
Subjects maintaining assisted primary patency of the endoAVF
Time frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Secondary Patency
Subjects maintaining secondary patency of the endoAVF
Time frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Functional Patency
Interval of time from endoAVF cannulation success to involuntary access abandonment
Time frame: through 24-months
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: 3-, 12-, 18-, and 24-months post index procedure
CVC Exposure/Use
Time frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Procedural Adjunctive Procedures
Adjunctive procedures performed at the time of the index procedure
Time frame: Index Procedure
Post Procedural Secondary Procedures
Number of secondary procedures conducted after the index procedure, broken down to identify interventions and second stage procedures
Time frame: 2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure