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Clinical Trials in China / NCT06567938
Recruiting Not applicable

Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease

NCT06567938 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Phase
Not applicable
Started
2024-07-25
Last updated
2024-08-23

Condition(s) studied

Coronary Artery DiseaseChronic Kidney Diseases

Investigational drug(s) / intervention(s)

Percutaneous coronary intervention

Percutaneous coronary intervention: PCI with DES implantation

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hopital of Xi'an Jiaotong University Xi'an Shaanxi Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06567938 on ClinicalTrials.gov ↗ ← All trials in China