Actively Recruiting
A Prospective, Multi-Center Clinical Study of the BD WavelinQ EndoAVF System for the Creation of Arteriovenous Fistula in Patients Requiring Dialysis
Led by C. R. Bard · Updated on 2026-03-27
280
Participants Needed
17
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the BD4 WavelinQ122 EndoAVF System for creating arteriovenous (AV) fistulas in patients who require dialysis due to end-stage kidney disease. This prospective, single-arm, multi-center post-market surveillance study aims to monitor the device's performance and safety in real-world use. The study focuses on patients with established, non-reversible kidney failure who are already on dialysis or need dialysis within six months. Participants will have an endoAVF created using the WavelinQ EndoAVF System, a device designed to form AV fistulas through an endovascular procedure. The study includes follow-up visits at multiple time points up to 24 months after the procedure to assess functional and physiological maturation, patency rates, cannulation success, and the need for additional procedures. The initial procedure success and safety, including device- and procedure-related serious adverse events within 30 days, are also closely monitored. During the study, participants will undergo regular evaluations such as ultrasound imaging and clinical assessments at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months after the procedure. Researchers will measure key outcomes including functional cannulation success, primary and assisted patency rates, and exposure to central venous catheters. The study aims to gather comprehensive data on safety, effectiveness, and long-term outcomes while ensuring participant follow-up and compliance over the two-year period.
CONDITIONS
Brief Title
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female aged 18 years or older with expected lifespan to complete study procedures
- Voluntarily signed informed consent before study data collection or procedures
- Willingness to comply with study protocol and clinical follow-up
- Established, non-reversible kidney failure on dialysis or needing dialysis within 6 months
- Target treatment vein diameter of at least 2.0 mm measured by ultrasound or venography
- Target treatment artery diameter of at least 2.0 mm measured by ultrasound or arteriogram
- Adequate collateral circulation to the hand as judged by the investigator
- At least one superficial outflow vein diameter of at least 2.5 mm connected to target site via proximal forearm perforating vein
You will not qualify if you...
- Hypercoagulable state
- Known bleeding diathesis
- Insufficient cardiac output to support native fistula as judged by investigator
- Active intravenous drug abuse history
- Planned major surgery within 6 months after or major surgery within 30 days before index procedure
- Allergy or hypersensitivity to contrast media not manageable by pre-medication
- Known adverse effects to sedation or anesthesia not manageable by pre-medication
- Active infection on day of procedure (fever 38.0�b0 Celsius or high white blood cell count)
- Medical conditions preventing compliance or with limited life expectancy as judged by investigator
- Participation in another investigational drug or device study interfering with endpoints
- Central venous stenosis or narrowing over 50% on same side as planned fistula
- Absence of proximal forearm perforating vein feeding target cannulation veins
- Occlusion or stenosis over 50% of target cannulation veins
- Significantly compromised venous or arterial flow in treatment arm
- Significant calcification at target fistula location affecting procedure effectiveness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Index procedure day
Participants will have an endoAVF created using the WavelinQ EndoAVF System.
1 visit (in-person)
Duration - Up to 24 months post-procedure
Participants are monitored regularly after the procedure to assess device function, maturation, and patency over time.
Multiple visits at 2 weeks, 6 weeks, 3, 6, 12, 18, and 24 months post-procedure
Trial Site Locations
Total: 17 locations
1
California Institute of Renal Research
La Jolla, California, United States, 92037
Actively Recruiting
2
San Francisco Vein & Vascular
San Francisco, California, United States, 94117
Actively Recruiting
3
First Coast Cardiovascular Institute Pa
Jacksonville, Florida, United States, 32256
Actively Recruiting
4
Radiology and Imaging Specialists
Lakeland, Florida, United States, 33801
Actively Recruiting
5
Vascular and Spine Institute Inc
Miami, Florida, United States, 33156
Active, Not Recruiting
6
Kidney Care and Transplant Services of NE
Springfield, Massachusetts, United States, 01089
Actively Recruiting
7
Kidney Care & Transplant Services of New England
West Springfield, Massachusetts, United States, 01089
Actively Recruiting
8
UMass Chan School of Medicine
Worcester, Massachusetts, United States, 01655
Actively Recruiting
9
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
10
NC Nephrology
Raleigh, North Carolina, United States, 27609
Completed
11
ProMedica Toledo Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
12
Butler Memorial Hospital
Butler, Pennsylvania, United States, 16001
Actively Recruiting
13
Vascular Institute of Chattanooga
Chattanooga, Tennessee, United States, 37421
Actively Recruiting
14
Bluff City Vascular
Memphis, Tennessee, United States, 38104
Actively Recruiting
15
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
16
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
17
Southern Adelaide Local Health Network
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
Research Team
C
Crystal Anderson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here