Critical Treatment of Coronary Artery Disease

NCT ID: NCT03195621

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2019-06-30

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.

Conditions

Coronary Artery Disease; Coronary Artery Disease Progression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Interventional therapy group

Group Type: EXPERIMENTAL

Stent implantation

Intervention Type: DEVICE

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

Conservative treatment group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stent implantation

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

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Science and Technology Department of Jiangsu Province

UNKNOWN

Sponsor Role: collaborator

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Genshan Ma

Director of cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gen-shan Ma, Ph.D

Role: STUDY_DIRECTOR

Southeast University

Locations

Zhongda Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

BE2016785

Identifier Type: -

Identifier Source: org_study_id