Critical Treatment of Coronary Artery Disease (CTCAD)

Southeast University, China

Status: Completed

Conditions: Coronary Artery Disease; Coronary Artery Disease Progression

Treatments: Device: Stent implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03195621

BE2016785

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Interventional therapy group

Experimental group

Treatment:

Device: Stent implantation

Conservative treatment group

No Intervention group