Status:
RECRUITING
Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Coronary Artery Disease
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 angi...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
1528 Patients enrolled
Trial Details
Trial ID
NCT06567938
Start Date
July 25 2024
End Date
December 1 2027
Last Update
August 23 2024
Active Locations (1)
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1
The First Affiliated Hopital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061