Using ultrasound to guide heart procedures in patients with kidney disease
Intravascular Ultrasound-Guided or Angiography-Guided Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease: The IVUS-CKD Trial
This study is testing if using ultrasound to guide heart procedures can help people with kidney disease have better results than the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1528 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06567938 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared to traditional angiography-guided PCI in patients suffering from chronic kidney disease (CKD). It is a prospective, randomized controlled trial that aims to determine if IVUS guidance can reduce target vessel failure (TVF) rates at 12 months post-procedure. The study involves patients with de novo coronary lesions who meet specific eligibility criteria, including a reduced kidney function. Participants will be monitored for outcomes related to their coronary artery disease and kidney health.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with chronic kidney disease and an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m² who require PCI for coronary artery disease.
Not a fit: Patients with acute coronary syndromes, severe comorbidities, or contraindications to the procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes for CKD patients undergoing heart procedures, potentially reducing complications and enhancing recovery.
How similar studies have performed: While the use of IVUS in PCI has been explored, this specific application in CKD patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Xi'an, Shaanxi
- The First Affiliated Hopital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: Ning Guo — The First Affiliated of Xi'an Jiaotong University
- Study coordinator: Ning Guo, PhD,MD
- Email: nguomd@mail.xjtu.edu.cn
- Phone: +86 13991229101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.