Actively Recruiting
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Led by C. R. Bard · Updated on 2026-03-27
280
Participants Needed
17
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject must be male or non-pregnant female aged 18 years or older with an expected lifespan sufficient to complete all study procedures
- Subject must voluntarily sign and date the Informed Consent Form before any study data collection or procedures
- Subject must be willing to comply with protocol requirements including clinical follow-up
- Subjects have established, non-reversible kidney failure and are currently on dialysis or expected to need dialysis within 6 months of endoAVF creation
- Target treatment vein diameter(s) for endoAVF creation must be at least 2.0 mm as measured by Duplex Ultrasound or Venography
- Target treatment artery diameter must be at least 2.0 mm as measured by Duplex Ultrasound or Arteriogram
- Subject must have adequate collateral circulation to the hand as judged by the Investigator
- At least one superficial outflow vein diameter must be at least 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein
You will not qualify if you...
- Subject is in a hypercoagulable state
- Subject has known bleeding diathesis
- Subject has insufficient cardiac output to support a native fistula as judged by the Investigator
- Subject has a known history of active intravenous drug abuse
- Planned major surgery within 6 months after the index procedure or major surgery within 30 days before the index procedure
- Subject has known allergy or hypersensitivity to contrast media that cannot be adequately pre-medicated
- Subject has known adverse effects to sedation or anesthesia that cannot be adequately pre-medicated
- Evidence of active infection on the day of the index procedure (fever of 38.0�b0 Celsius or higher and/or white blood cell count of 12,000 cells/�bcL or higher, if collected)
- Subject has another medical condition that may cause non-compliance, confound data interpretation, or limit life expectancy to complete study procedures
- Subject is currently in another investigational drug or device study that is not completed or interferes with study endpoints
- Subject has central venous stenosis or narrowing greater than 50% on the same side as planned endoAVF creation
- Absence of a proximal forearm perforating vein feeding the target cannulation vein from the target creation site
- Occlusion or stenosis greater than 50% of target cannulation veins such as cephalic, median cubital, basilic veins
- Significantly compromised venous or arterial flow in the treatment arm as determined by Investigator and imaging
- Presence of significant calcification at the target endoAVF location that could affect effectiveness of endoAVF creation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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