Imaging-Guided Heart Stent Procedure Tested in Adults With Kidney Disease
Compares ultrasound-guided and standard X-ray-guided stenting in adults with heart and kidney disease.
Plain-language title generated from the registry record
Registry title: Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
Key facts
- Where
- Xi'an, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic kidney disease and a new narrowing in a heart artery that can be treated with a drug-coated stent and ultrasound imaging.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Chronic kidney disease with eGFR below 60 mL/min/1.73 m^2, plus a new (de novo) coronary lesion that can be treated with a second-generation metallic drug-eluting stent and imaged with IVUS.
- Earlier treatment
- People who had a PCI in the previous 12 months cannot join.
- Biomarker or test result
- eGFR below 60 mL/min/1.73 m^2.
Main reasons for not taking part
- Heart attack (STEMI) within 24 hours, or emergency angiography
- Pregnant or childbearing women
- Heart pumping strength (LVEF) of 30% or lower, or cardiogenic shock
- Taking anticoagulants, or unable to take anti-platelet drugs
- Life expectancy under 1 year
Read by machine on 9 November 2026.
Where in China
- The First Affiliated Hopital of Xi'an Jiaotong UniversityXi'an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital Xi'an Jiaotong University
- Trial code
- NCT06567938
- Record updated
- 23 August 2024
- Original description
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.Read full original descriptionShow less
Intravascular Ultrasound-Guided or Angiography-Guided Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease: The IVUS-CKD Trial
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.
Inclusion: 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: PCI within the previous 12 months; Current intake of nephrotoxic medications (e.g., nonsteroidal anti-inflammatory drugs except acetylsalicylic acid, phenylbutazone, aminoglycosides, amphotericin B, polymyxin, platinum complexes); Planned exposure to contrast within 72 h after the procedure, intravascular administration of contrast within the previous 5 days; Target lesion of stent thrombosis or in-stent restenosis; Any planned non-cardiac surgery within 12 months; History of intracranial or gastrointestinal bleeding requiring transfusion or surgical intervention for control (excluding hemorrhoid); Immune-related kidney disease or on hormone therapy (e.g. lupus nephritis, IgA nephropathy); Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial; Patients allergic to metals or contrast; LVEF ≤ 30%; Severe hepatic dysfunction, defined as ALT or AST more than 5 times the ULN; Contraindication to anti-platelet agents; Hemoglobin <60 g/L; Onset of STEMI within 24 hours or emergent angiography; Pregnant or childbearing women; Co-morbidity with an estimated life expectancy of < 1 year; Cardiogenic shock or hemodynamic instability; 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; Chronic total occlusion lesion with unsuccessful guidewire crossing; Intake of anticoagulants.