Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases; Coronary Artery Disease

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

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-07-10
• Study Start: 2024-07-25
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1528

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)	12 months	The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups.

Secondary Outcome Measures

Name	Time	Method
Target vessel MI	12 months
Hierarchical composite of target vessel failure	12 months	Hierarchical composite of cardiac death, target vessel MI, or clinically driven target vessel revascularization after randomization analyzed by win ratio method.
30-day cardiorenal endpoint	30 days	A composite of contrast-associated acute kidney injury (CA-AKI), requiring specific treatment for acute renal failure, persistent decline in eGFR, MI, or all-cause death.
Cardiac death	12 months	Death that could not be attributed to a noncardiac etiology is considered cardiac death.
Clinically driven target vessel revascularization	12 months	Any clinically driven repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
Spontaneous MI	12 months
Target vessel failure excluding periprocedural MI	12 months	The difference will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.
Clinically driven target lesion revascularization	12 months
Target lesion failure	12 months	A composite of cardiac death, target vessel related MI, or clinically driven target lesion revascularization.
Major adverse cardiovascular event	12 months	A composite of cardiac death, MI, definite stent thrombosis (ST), or clinically driven TVR

Trial Locations

Locations (1)

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