Critical Treatment of Coronary Artery Disease

NCT03195621 | Completed DMC

• 1 other identifier: BE2016785
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Coronary Artery Disease; Critical lesion

Outcome Measures

Primary Outcomes (1)

• Major cardiovascular adverse events

  Cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis

  one year after enrollment

Secondary Outcomes (1)

• Chest pain

  one year after enrollment

Study Arms (2)

Interventional therapy group

EXPERIMENTAL

Device: Stent implantation

Conservative treatment group

NO INTERVENTION

Interventions

Stent implantation DEVICE

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

Interventional therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Southeast University, China: lead
• Science and Technology Department of Jiangsu Province: collaborator

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 320000, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gen-shan Ma, Ph.D

  Southeast University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of cardiology

Model Details: 2 groups

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 22, 2017
• Study Start: July 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2019
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

CN (1)