Critical Treatment of Coronary Artery Disease (CTCAD)

Treatment Strategy for Critical Lesions of Coronary Artery Disease

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Artery Disease Progression
• Intervention / Treatment: Device: Stent implantation

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen-bin Lu, Ph.D; Phone Number: 025-83262565; Email: luwenbinseu@163.com
• Study Contact Backup: Name: Jian Zhu, Ph.D; Phone Number: 025-83262596; Email: njzhujian@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 320000
      • Zhongda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional therapy group	Device: Stent implantation; Stent placement after risk factors assessment plus FFR or ultrasound or OCT detection for critical lesions.
No Intervention: Conservative treatment group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest pain	Frequency of angina pectoris	one year after enrollment

Collaborators and Investigators

• Sponsor: Southeast University, China
• Collaborators: Science and Technology Department of Jiangsu Province
• Investigators: Study Director: Gen-shan Ma, Ph.D, Southeast university

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Critical lesion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Disease Progression
• Other Study ID Numbers: BE2016785

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We do not decide whether to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No