Critical Treatment of Coronary Artery Disease

Study Overview
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Brief Summary
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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.

Official Title
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Treatment Strategy for Critical Lesions of Coronary Artery Disease

Conditions
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Coronary Artery Disease, Coronary Artery Disease Progression

Intervention / Treatment
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* Device: Stent implantation


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional therapy group<br> | Device: Stent implantation<br>* Stent placement after risk factors assessment plus FFR or ultrasound or OCT detection for critical lesions.<br>|
| No Intervention: Conservative treatment group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiovascular adverse events | Cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis | one year after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest pain | Frequency of angina pectoris | one year after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Critical lesion