Actively Recruiting
Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2024-08-23
1528
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic kidney disease patients with an estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m²
- New coronary artery lesion suitable for second-generation metallic drug-eluting stent placement and intravascular ultrasound imaging
- Signed written informed consent
You will not qualify if you...
- Onset of ST-segment elevation myocardial infarction (STEMI) within 24 hours or emergent angiography
- Pregnant or childbearing women
- Co-morbidity with an estimated life expectancy of less than 1 year
- Left ventricular ejection fraction (LVEF) 30% or less
- Cardiogenic shock or hemodynamic instability
- Severe liver dysfunction, defined as ALT or AST greater than 5 times the upper limit of normal
- Percutaneous coronary intervention 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 or comply with follow-up requirements
- Current enrollment in other clinical trials
- Contraindication to anti-platelet agents
- History of intracranial or gastrointestinal bleeding requiring transfusion or surgery (excluding hemorrhoids)
- Chronic total occlusion lesion with unsuccessful guidewire crossing
- Current use of nephrotoxic medications (except aspirin)
- Immune-related kidney disease or hormone therapy for kidney disease
- Planned exposure to contrast within 72 hours after procedure or intravascular contrast within previous 5 days
- Current use of anticoagulants
- Hemoglobin less than 60 g/L
- Severe valvular disease or likely to require valve surgery or replacement during the trial
- Allergy to metals or contrast agents
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hopital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
Research Team
N
Ning Guo, PhD,MD
CONTACT
X
Xin Huang, PhD,MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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