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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Percutaneous coronary intervention

PCI with DES implantation

Locations (1)

The First Affiliated Hopital of Xi'an Jiaotong University
Xi'an, Shaanxi, China