50
Participants
Start Date
August 3, 2021
Primary Completion Date
September 30, 2026
Study Completion Date
September 30, 2026
Venography
The venography will be performed as part of the patient's standard of care. The dialysis access will be punctured upstream of the arteriovenous anastomosis in AVF or AVG using a 4-F coaxial access set (Micro- puncture; Cook, Inc, Bloomington, Indiana). The contrast will be injected intravenously by a pump with 200 psi and a bolus of 2m/sec for total of 5 ml during upper extremity vein filming and 10 ml of contrast bolus by 3 ml/s during central vein filming while holding the breath in inspiration in anterioposterior plane.
Intravascular ultrasound (IVUS)
IVUS will be performed through the same sheath of the coaxial access set using an Eagle Eye Platinum RX digital catheter 7F over a compatible guidewire under fluoroscopic guidance. The lesion will be estimated fluoroscopically from the marker IVUS catheter in the vein and the cranial and caudal margins of stenotic lesion will be directly visualized during pullback of the IVUS catheter.
Image processing
Image processing will be performed by two radiologists in a blinded manner on the images devoid of personal identifier. An adjudication committee will oversee the process and confirm their findings in case of a discrepancy.
RECRUITING
Boston Medical Center, Boston
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Boston Medical Center
OTHER