This study aims to evaluate the treatment of Chronic total occlusion (CTO) disease. Whether Intravascular Ultrasonography (IVUS) guiding the implantation of drug-eluting stents (DES) will provide better long-term clinical outcomes compared with conventional angiography
At least 18 years old
Subjects will understand the test requirements, treatment and surgery, and can provide written informed consent
Subjects with clinical symptoms of ischemic heart disease or evidence of myocardial ischemia associated with CTO target vessels and scheduled to undergo Percutaneous coronary intervention (PCI)
Subjects will receive percutaneous coronary intervention
Pregnant and lactating women
Severe coronary artery disease, not suitable for PCI
Patients with acute myocardial infarction less than 7 days
Long-term contraindications to DAPT (at least 1 year)
Parallel
The guidewire successfully passed the CTO lesion
Procedure/SurgeryThe successful passage of the guide wire through the CTO lesion was defined as: the guide wire successfully passed through the CTO lesion and reached the distal true lumen as confirmed by angiography. Aspirin load dose (300 mg), clopidogrel load dose (300 mg), or ticagrelor load dose (180 mg) is recommended for all subjects prior to stent implantation and is recommended to be taken at least 6 hours prior to surgery.
Major adverse cardiac events
All causes of death, myocardial infarction, stent thrombosis (ARC clear/probable), and clinically driven target vessel revascularization
Cardiogenic death
This includes acute myocardial infarction, cardiac perforation/tamponade, arrhythmia or conduction abnormalities, cerebrovascular accidents at discharge or suspected operating-related cerebrovascular accidents, death from surgical complications, including hemorrhage, vascular repair, transfusion reaction, or bypass surgery, or any death of cardiac origin that cannot be ruled out.
Nonfatal myocardial infarction
Nonfatal myocardial infarction
Target lesion revascularization
Target lesion revascularization is any ischemia-driven repetitive percutaneous coronary intervention to improve blood flow to a successfully treated target lesion or to bypass the target vessel and use a graft distally to the successfully treated target lesion. If the target lesion diameter is ≥50% stenosis as assessed by QCA and there is clinical or functional ischemia that cannot be explained by other coronary or graft lesions, vascularization will be considered to be induced by ischemia.
Target vessel revascularization
Target vessel revascularization is defined as repeated intervention in the vessel where the target lesion is located in reference to target lesion revascularization
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CCRF Inc., Beijing, China
Lead sponsor
General Hospital of Shenyang Military Region
Sponsor institution
BSC International Medical Trading (Shanghai) Co., Ltd.
Collaborator
