Critical Treatment of Coronary Artery Disease

Overview

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.

Full Title of Study: “Treatment Strategy for Critical Lesions of Coronary Artery Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2018

Interventions

  • Device: Stent implantation
    • Stent placement after risk factors assessment plus FFR or ultrasound or OCT detection for critical lesions.

Arms, Groups and Cohorts

  • Experimental: Interventional therapy group
  • No Intervention: Conservative treatment group

Clinical Trial Outcome Measures

Primary Measures

  • Major cardiovascular adverse events
    • Time Frame: one year after enrollment
    • Cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis

Secondary Measures

  • Chest pain
    • Time Frame: one year after enrollment
    • Frequency of angina pectoris

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Southeast University, China
  • Collaborator
    • Science and Technology Department of Jiangsu Province
  • Provider of Information About this Clinical Study
    • Principal Investigator: Genshan Ma, Director of cardiology – Southeast University, China
  • Overall Official(s)
    • Gen-shan Ma, Ph.D, Study Director, Southeast University

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