Clinical trial NCT06567938: Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
Official title: Intravascular Ultrasound-Guided or Angiography-Guided Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease: The IVUS-CKD Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Chronic Kidney Diseases
Keywords: Coronary Artery Disease
Chronic Kidney Disease
Percutaneous Coronary Intervention
Intravascular Ultrasound
Randomized Trial
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 1528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* CKD patients with eGFR\<60 mL/min/1.73 m\^2
* De novo coronary lesion suitable for second-generation metallic drug-eluting stent placement and IVUS imaging
* Signed written informed consent

Exclusion Criteria:

* 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%
* Cardiogenic shock or hemodynamic instability
* Severe hepatic dysfunction, defined as ALT or AST more than 5 times the ULN
* PCI within the previous 12 months
* Target lesion of stent thrombosis or in-stent restenosis
* Any planned non-cardiac surgery within 12 months
* Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk
* Current enrolment in other clinical trials
* Contraindication to anti-platelet agents
* History of intracranial or gastrointestinal bleeding requiring transfusion or surgical intervention for control (excluding hemorrhoid)
* Chronic total occlusion lesion with unsuccessful guidewire crossing
* Current intake of nephrotoxic medications (e.g., nonsteroidal anti-inflammatory drugs except acetylsalicylic acid, phenylbutazone, aminoglycosides, amphotericin B, polymyxin, platinum complexes)
* Immune-related kidney disease or on hormone therapy (e.g. lupus nephritis, IgA nephropathy)
* Planned exposure to contrast within 72 h after the procedure, intravascular administration of contrast within the previous 5 days
* Intake of anticoagulants
* Hemoglobin \<60 g/L
* Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
* Patients allergic to metals or contrast

Primary outcomes:
measure: Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR)
timeFrame: 12 months
Secondary outcomes:
measure: Hierarchical composite of target vessel failure
timeFrame: 12 months
measure: 30-day cardiorenal endpoint
timeFrame: 30 days
measure: Target vessel failure excluding periprocedural MI
timeFrame: 12 months
measure: Cardiac death
timeFrame: 12 months
measure: Target vessel MI
timeFrame: 12 months
measure: Clinically driven target vessel revascularization
timeFrame: 12 months
measure: Spontaneous MI
timeFrame: 12 months
measure: Target lesion failure
timeFrame: 12 months
measure: Clinically driven target lesion revascularization
timeFrame: 12 months
measure: Major adverse cardiovascular event
timeFrame: 12 months
Other outcomes:
measure: Renal outcomes
timeFrame: 12 months
measure: Annual change in eGFR from baseline
timeFrame: 12 months
measure: Clinically relevant bleeding
timeFrame: 12 months
measure: Major bleeding
timeFrame: 12 months
measure: All-cause death
timeFrame: 12 months
measure: Definite or probable stent thrombus (ST)
timeFrame: 12 months
measure: Procedure time
timeFrame: during PCI
measure: Radiation exposure
timeFrame: during PCI
measure: Total amount of contrast use
timeFrame: during PCI
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hopital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: The First Affiliated of Xi'an Jiaotong University
name: Ning Guo
role: PRINCIPAL_INVESTIGATOR
References: