Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
NCT Number: NCT06567938
Acronym: IVUS-CKD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Disease|Chronic Kidney Diseases
Interventions: PROCEDURE: Percutaneous coronary intervention
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1528
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2027-12
Locations: The First Affiliated Hopital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, China

Summary:
The IVUS-CKD study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (IVUS)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (CKD) patients with respect to target vessel failure (TVF) at 12 months after randomization.

Primary Outcome Measures: Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR), The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups., 12 months
Secondary Outcome Measures: Hierarchical composite of target vessel failure, Hierarchical composite of cardiac death, target vessel MI, or clinically driven target vessel revascularization after randomization analyzed by win ratio method., 12 months|30-day cardiorenal endpoint, A composite of contrast-associated acute kidney injury (CA-AKI), requiring specific treatment for acute renal failure, persistent decline in eGFR, MI, or all-cause death., 30 days|Target vessel failure excluding periprocedural MI, The difference will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups., 12 months|Cardiac death, Death that could not be attributed to a noncardiac etiology is considered cardiac death., 12 months|Target vessel MI, 12 months|Clinically driven target vessel revascularization, Any clinically driven repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion., 12 months|Spontaneous MI, 12 months|Target lesion failure, A composite of cardiac death, target vessel related MI, or clinically driven target lesion revascularization., 12 months|Clinically driven target lesion revascularization, 12 months|Major adverse cardiovascular event, A composite of cardiac death, MI, definite stent thrombosis (ST), or clinically driven TVR, 12 months
Other Outcome Measures: Renal outcomes, A composite of requiring specific treatment for acute renal failure (continuous renal replacement therapy, or dialysis), chronic dialysis (peritoneal dialysis, or hemodialysis), persistent decline in eGFR, or renal death., 12 months|Annual change in eGFR from baseline, total slope, 12 months|Clinically relevant bleeding, Bleeding Academic Research Consortium Definition for Bleeding types 2，3 or 5, 12 months|Major bleeding, Bleeding Academic Research Consortium Definition for Bleeding types 3 or 5, 12 months|All-cause death, 12 months|Definite or probable stent thrombus (ST), ST was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC)., 12 months|Procedure time, From first wire insertion to guide catheter removal., during PCI|Radiation exposure, From first wire insertion to guide catheter removal., during PCI|Total amount of contrast use, From first wire insertion to guide catheter removal., during PCI