Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 3, 2021

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
End Stage Renal Disease
Interventions
DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

OTHER

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.

Trial Locations (1)

02118

RECRUITING

Boston Medical Center, Boston

Sponsors
All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Boston Medical Center

OTHER

NCT04399941 - Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis | Biotech Hunter | Biotech Hunter