Coronary Artery Disease, Coronary Artery Disease Progression
Conditions
Keywords
Coronary Artery Disease, Critical lesion
Brief summary
Identifying the critical lesion of coronary artery disease and determining the interventional plan are significant for reducing adverse cardiovascular adverse events. The assessment of critical lesion requires the consideration of plaque morphology, tissue composition, and endometrial stress which leading to rupture. In summary, accurate assessment of critical lesions has high application value. In this study, patients with critical coronary artery disease were divided into two groups: an accurate assessment group and a simple assessment group, with the aim to compare the diagnosis and treatment efficiency as well as prognosis, potential cardiovascular risk, possible excessive intervention.
Interventions
DEVICEStent implantation
Stent placement after risk factors assessment plus FFR or ultrasound or OCT detection for critical lesions.
Sponsors
Science and Technology Department of Jiangsu Province
Southeast University, China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
2 groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Volunteered to participate in this study and signed an informed consent form; Men or non-pregnant women ≥ 18 and ≤80 years of age; Lesion is located in a coronary artery and stenosis is between 50-75%;
Exclusion criteria
Severe liver and kidney diseases (GFR\<60 ml/min/1.73m2 or CTP≥6 score); Moderate to severe hypertension (after standard antihypertensive therapy, blood pressure higher than 160/100mmHg); Patients with hemodynamic or electrical instability (including shock); Coagulation disorders associated with significant bleeding tendency (eg, hypersensitivity, active bleeding, moderate or severe liver disease, GI bleed within the past 6 months, major surgery within 30 days); Patients with ischemic stroke within one week; Any contraindication against the use of anti-platelet drugs such as aspirin; Platelet count less than 100 x 109/L, haemoglobin (Hb) level less than 100 g/L; Researchers involved in the study and / or immediate family members; Participation in another investigation drug or device study in the past 30 days before enrollment; Involvement in the planning and conduct of the study (applies to staffs at study sites); Suffering from serious arrhythmias include recurrent ventricular tachycardia or ventricular fibrillation; Pregnancy or lactation or females of child-bearing potential with the plan of pregnancy in one year;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major cardiovascular adverse events | one year after enrollment | Cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chest pain | one year after enrollment | Frequency of angina pectoris |
Countries
China
Outcome results
None listed