RecruitingNot ApplicableNCT06567938

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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Enrollment

1,528 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Diseases Coronary Artery Disease

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria21

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