A Prospective, Single-site, Single-group Value Study on the Diagnosis of Functional Myocardial Ischemia Based on IVUS Plaque Characteristics

Insight Lifetech

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07176585

CIP-0201

Details and patient eligibility

About

This study aims to evaluate the accuracy of IVUS-calculated percent atheroma volume (PAV) for diagnosing functional myocardial ischemia, using FFR as the gold standard.

Full description

This prospective, single-site, single-group target-value study aims to investigate the accuracy of intravascular ultrasound (IVUS)-based plaque characteristics in diagnosing functional myocardial ischemia, using coronary fractional flow reserve (FFR) as the gold standard.

Enrollment: 105 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Study participants must be at least 18 years of age and younger than 80 years of age, regardless of gender;
2. Stable coronary artery disease, unstable angina, or acute myocardial infarction (AMI ≥ 7 days);
3. Coronary angiography showed primary lesions with a visual stenosis of 30% to 90% in at least two coronary arteries ≥ 2.5 mm in diameter;
4. Willing to participate in the study and able to understand, read, and sign the informed consent form.

Exclusion criteria

1. STEMI as clinical presentation within 7 days;
2. Chronic Total Occlusion (CTO) as target vessel;
3. Significant contraindication to adenosine administration (e.g., atrioventricular block, severe asthma, etc.);
4. Study participants are currently participating in other drug or device clinical studies and have not achieved the study endpoints;
5. Pregnant or nursing;
6. Other situations considered by the investigator as unsuitable for participation in this study.