Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
- Conditions
- Chronic Kidney DiseasesCoronary Artery Disease
- Interventions
- Procedure: Percutaneous coronary intervention
- Registration Number
- NCT06567938
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1528
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Angiography-guidance PCI Percutaneous coronary intervention Angiographic success is defined as thrombolysis in myocardial infarction (TIMI) flow grade 3, and residual stenosis \< 20%. IVUS-guidance PCI Percutaneous coronary intervention In the IVUS-guidance group, the optimal stent deployment criteria for non-left main lesion will include the following: : (1) the minimal lumen area (MLA) in the stented segment \> 5.0 mm\^2 or \> 90% of the MLA at the distal reference segments, (2) plaque burden 5 mm proximal or distal to the stent edge is \< 55%, and (3) absence of medial dissection over 3 mm in length. In the setting of a two-stent approach for distal left main bifurcation lesions, the optimal stent deployment criteria are an absolute minimal stent area (MSA) greater than 8 mm\^2 for the left main, greater than 7 mm\^2 for carina, greater than 6 mm\^2 for the ostial or proximal left anterior descending artery, and greater than 5 mm\^2 for the ostial or proximal left circumflex artery. For left main lesion treated with single-stent technique, the criteria are greater than 7mm\^2 for distal and greater than 8mm\^2 for proximal. Further treatment will be required if the criteria are not met.
- Primary Outcome Measures
Name Time Method Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) 12 months The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups.
- Secondary Outcome Measures
Name Time Method Hierarchical composite of target vessel failure 12 months Hierarchical composite of cardiac death, target vessel MI, or clinically driven target vessel revascularization after randomization analyzed by win ratio method.
30-day cardiorenal endpoint 30 days 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.
Cardiac death 12 months Death that could not be attributed to a noncardiac etiology is considered cardiac death.
Target vessel MI 12 months Clinically driven target vessel revascularization 12 months Any clinically driven repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
Spontaneous MI 12 months Target vessel failure excluding periprocedural MI 12 months The difference will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.
Clinically driven target lesion revascularization 12 months Target lesion failure 12 months A composite of cardiac death, target vessel related MI, or clinically driven target lesion revascularization.
Major adverse cardiovascular event 12 months A composite of cardiac death, MI, definite stent thrombosis (ST), or clinically driven TVR
Trial Locations
- Locations (1)
The First Affiliated Hopital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China