Critical Treatment of Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— CTCAD  

Official title:

Treatment Strategy for Critical Lesions of Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195621
• Other study ID #: BE2016785
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2023
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease Progression
• Coronary Disease
• Disease Progression
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Southeast University, China	Science and Technology Department of Jiangsu Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major cardiovascular adverse events	Cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis	one year after enrollment
Secondary	Chest pain	Frequency of angina pectoris	one year after enrollment