Phase
Condition
N/ATreatment
surgical intervention for creation of a fistula
AV graft
Clinical Study ID
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 60 years or older
End-stage kidney disease on hemodialysis via a central venous catheter
Hemodialysis is the long-term modality of treatment for end-stage kidney disease
Central venous catheter is the sole vascular access used for hemodialysis at thetime of referral for arteriovenous access creation
Referred by patient's nephrologist for placement of arteriovenous access
At least one of the following comorbid conditions: cardiovascular disease,peripheral vascular disease, and/or diabetes mellitus
Medically and surgically eligible to undergo surgical placement of an arteriovenousaccess, deemed by the treating healthcare providers
Native vasculature deemed preoperatively to be suitable for surgical creation ofeither type of arteriovenous access (arteriovenous fistula or arteriovenous graft)in the opinion of the surgeon
Patient agreed to study participation and signed the informed consent
Exclusion
Exclusion Criteria:
Severe cardiac disease defined as presence of either of the following threeconditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant,or ventricular assist device
Known or suspected central vein stenosis or vascular obstruction on the side ofplanned study access creation, unless corrected prior to randomization
Planned arteriovenous fistula creation by means other than suture or vascularanastomotic clips (e.g. endovascular surgery or other anastomotic creation devices)
Anticipated kidney transplant within 12 months
Anticipated conversion to peritoneal dialysis within 12 months
Anticipated transfer of nephrology care to a clinic outside the study participatingcenters within 12 months
Anticipated non-compliance with medical care based on physician judgment
A condition in which, in the opinion of the site PI renders the patient not a goodcandidate for study participation.
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama 35487
United StatesActive - Recruiting
UCLA
Los Angeles, California 90095
United StatesActive - Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland 21205
United StatesTerminated
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Atrium Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
Cleveland Clinic Glickman Urological and Kidney Institute
Cleveland, Ohio 44125
United StatesSite Not Available
Prisma Health Upstate
Greenville, South Carolina 29601
United StatesActive - Recruiting
University of Tennessee Medical Center at Knoxville
Knoxville, Tennessee 37920
United StatesActive - Recruiting
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin 53726
United StatesActive - Recruiting
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