Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease, Chronic Kidney Diseases

In brief

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.

Key facts

Study ID

NCT06567938

Run by

First Affiliated Hospital Xi'an Jiaotong University

People needed

1528

Starts

2024-07-25

Expected to finish

2027-12-01

Last updated by the study team

2024-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The First Affiliated Hopital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.