NCT06567938 Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
| NCT ID | NCT06567938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,528 participants |
| Start Date | 2024-07-25 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,528 participants in total. It began in 2024-07-25 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Ning Guo
PRINCIPAL INVESTIGATOR
The First Affiliated of Xi'an Jiaotong University
Frequently Asked Questions
Who can join the NCT06567938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06567938 currently recruiting?
Yes, NCT06567938 is actively recruiting participants. Contact the research team at nguomd@mail.xjtu.edu.cn for enrollment information.
Where is the NCT06567938 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06567938 clinical trial?
NCT06567938 is sponsored by First Affiliated Hospital Xi'an Jiaotong University. The principal investigator is Ning Guo at The First Affiliated of Xi'an Jiaotong University. The trial plans to enroll 1,528 participants.