Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease

Intravascular Ultrasound-Guided or Angiography-Guided Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease: The IVUS-CKD 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.

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