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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,528
PCI with DES implantation
The First Affiliated Hopital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGTarget 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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Cardiac death
Death that could not be attributed to a noncardiac etiology is considered cardiac death.
Time frame: 12 months
Target vessel MI
Time frame: 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.
Time frame: 12 months
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Spontaneous MI
Time frame: 12 months
Target lesion failure
A composite of cardiac death, target vessel related MI, or clinically driven target lesion revascularization.
Time frame: 12 months
Clinically driven target lesion revascularization
Time frame: 12 months
Major adverse cardiovascular event
A composite of cardiac death, MI, definite stent thrombosis (ST), or clinically driven TVR
Time frame: 12 months