Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital Xi'an Jiaotong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
CKD patients with eGFR<60 mL/min/1.73 m²
De novo coronary lesion suitable for second-generation metallic drug-eluting stent placement and IVUS imaging
Signed written informed consent
Disqualifiers
Onset of STEMI within 24 hours or emergent angiography
Pregnant or childbearing women
Co-morbidity with an estimated life expectancy of < 1 year
LVEF ≤ 30%
Trial design
Design model
Parallel
Treatments tested in this trial
Percutaneous coronary intervention
Procedure/SurgeryPCI with DES implantation
Treatment groups
1,528 Participants
are divided into 2 treatment groupsGroup A: IVUS-guidance PCIExperimental treatment 1 intervention
Group B: Angiography-guidance PCIActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 monthsSecondary outcomes
1
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 months2
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 days3
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 months4
Cardiac death
Death that could not be attributed to a noncardiac etiology is considered cardiac death.
Time frame
12 monthsOther outcomes
1
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.
Time frame
12 months2
Annual change in eGFR from baseline
total slope
Time frame
12 months3
Clinically relevant bleeding
Bleeding Academic Research Consortium Definition for Bleeding types 2，3 or 5
Time frame
12 months4
Major bleeding
Bleeding Academic Research Consortium Definition for Bleeding types 3 or 5
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov