Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney 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

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

Conditions3

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