This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
304
Subjects assigned to the Diagnostic Arm will have the EchoMark implanted at the time of AVF creation. The subject will return every 2 weeks for a follow-up assessment to include an EchoSure scan until fistula maturation and/or permanent access use is achieved. The EchoSure scans are to be reviewed by the investigator(s) or delegated study staff and aid in the determination when a further assessment, including a physical exam, is required to determine cannulation clearance or if an intervention(s) may be required to prevent failure of fistula maturation. All physical exams will include assessing the fistula for bruit and thrill. The subject's medical history will be reviewed at each visit and will include all interventions, cannulation attempts, and adverse event reporting.
Subjects are assessed using standard of care per KDOQI guidelines, which includes a physical exam at the 2-week follow-up visit and at the 4-6-week follow-up visit. All follow-up visits will include an assessment of adverse events and medical history review to include all interventions, cannulation attempts, and laboratory results. If evaluation yields an abnormal finding, subjects will undergo a Duplex ultrasound assessment and treatment under the institution's standard of care. All SOC Arm subjects will be followed per the institution's standard of care until fistula maturation occurs and/or permanent access use is achieved but no more frequently than once per month.
Trinity Research Group
Dothan, Alabama, United States
Primary Safety Endpoint
Freedom from the following through 6 months as adjudicated by the CEC: 1. Clinically significant misplacement or migration of the EchoMark implant. 2. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention. 3. Infection of tissues surrounding the EchoMark implant requiring IV/ 4. Complication requiring explantation of the EchoMark implant.
Time frame: 6 months
Primary Effectiveness Endpoint
Time to clinical maturation
Time frame: 6 months
Difference between EchoSure and Duplex Flow Measurements
Difference between log10-transformed EchoSure and Duplex flow measurements of blood flow for assessment of measurement agreement in the diagnostic arm.
Time frame: 6 Months
EchoSure Depth Comparison
Difference between EchoSure and CoreLab measurements of depth for assessment of measurement agreement in the diagnostic arm.
Time frame: 6 Months
EchoSure Diameter Comparison
Difference between EchoSure and CoreLab measurement of diameter for assessment of measurement agreement in the diagnostic arm.
Time frame: 6 Months
EchoMark/EchoSure System Technical Success
Technical Success defined as the successful implantation of the EchoMark implant and the ability to complete each scan to determine the blood flow, diameter, and depth measurements at the EchoMark using the EchoSure diagnostic ultrasound system from baseline to Clinical Maturation, fistula failure, or 4 months, whichever is sooner.
Time frame: 4 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Southwest Kidney Institute
Phoenix, Arizona, United States
RECRUITINGAKDHC Medical Research Services
Phoenix, Arizona, United States
RECRUITINGAKDHC Center Tucson
Tucson, Arizona, United States
RECRUITINGOrlando Health Heart and Vascular Institute
Orlando, Florida, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGKansas Nephrology Research Institute
Wichita, Kansas, United States
RECRUITINGBoston Medical Center
Boston, Massachusetts, United States
RECRUITINGMSU Health Care Heart and Vascular
Lansing, Michigan, United States
RECRUITINGCapital Medical Center
Pennington, New Jersey, United States
RECRUITING...and 10 more locations
CVC Removal
Time to CVC removal by subject group
Time frame: 6 Months
Rate of Hospitalization
Rate of hospitalization(s) by subject group from baseline to Clinical Maturation.
Time frame: 6 Months
AV Fistula Maturation Rate
Percent of AVFs created that mature by 180 days by subject group.
Time frame: 6 Months
Total Cost of Care
Total cost of care, defined by National average Medicare payment rate (facility and professional fees) for procedures and care provided to subject by subject group from baseline to Clinical Maturation.
Time frame: 6 Months
Freedom from Events through 30 and 90 Days
Freedom from the following through 30 and 90 days from the baseline procedure as adjudicated by the CEC: 1. Clinically significant misplacement or migration of the EchoMark implant. 2. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention. 3. Infection of tissues surrounding the EchoMark implant requiring IV antibiotic treatment. 4. Complication requiring explantation of the EchoMark implant.
Time frame: 30 Days and 90 Days