Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Chronic Kidney Diseases

• Registration Number: NCT06567938
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-10
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - CKD patients with eGFR<60 mL/min/1.73 m^2<br><br> - De novo coronary lesion suitable for second-generation metallic drug-eluting stent<br> placement and IVUS imaging<br><br> - Signed written informed consent<br><br>Exclusion Criteria:<br><br> - Onset of STEMI within 24 hours or emergent angiography<br><br> - Pregnant or childbearing women<br><br> - Co-morbidity with an estimated life expectancy of < 1 year<br><br> - LVEF = 30%<br><br> - Cardiogenic shock or hemodynamic instability<br><br> - Severe hepatic dysfunction, defined as ALT or AST more than 5 times the ULN<br><br> - PCI within the previous 12 months<br><br> - Target lesion of stent thrombosis or in-stent restenosis<br><br> - Any planned non-cardiac surgery within 12 months<br><br> - Inability to follow the protocol and comply with follow-up requirements or any other<br> reason that the investigator feels would place the patient at increased risk<br><br> - Current enrolment in other clinical trials<br><br> - Contraindication to anti-platelet agents<br><br> - History of intracranial or gastrointestinal bleeding requiring transfusion or<br> surgical intervention for control (excluding hemorrhoid)<br><br> - Chronic total occlusion lesion with unsuccessful guidewire crossing<br><br> - Current intake of nephrotoxic medications (e.g., nonsteroidal anti-inflammatory<br> drugs except acetylsalicylic acid, phenylbutazone, aminoglycosides, amphotericin B,<br> polymyxin, platinum complexes)<br><br> - Immune-related kidney disease or on hormone therapy (e.g. lupus nephritis, IgA<br> nephropathy)<br><br> - Planned exposure to contrast within 72 h after the procedure, intravascular<br> administration of contrast within the previous 5 days<br><br> - Intake of anticoagulants<br><br> - Hemoglobin <60 g/L<br><br> - Severe valvular disease or valvular disease likely to require surgery or<br> percutaneous valve replacement during the trial<br><br> - Patients allergic to metals or contrast

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

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)

Secondary Outcome Measures

Name	Time	Method
Hierarchical composite of target vessel failure;30-day cardiorenal endpoint;Target vessel failure excluding periprocedural MI;Cardiac death;Target vessel MI;Clinically driven target vessel revascularization;Spontaneous MI;Target lesion failure;Clinically driven target lesion revascularization;Major adverse cardiovascular event