Status:
NOT_YET_RECRUITING
A Prospective, Single-site, Single-group Value Study on the Diagnosis of Functional Myocardial Ischemia Based on IVUS Plaque Characteristics
Lead Sponsor:
Insight Lifetech Co., Ltd.
Collaborating Sponsors:
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Brief Summary
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.
Detailed 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 isch...
Eligibility Criteria
Inclusion
- Study participants must be at least 18 years of age and younger than 80 years of age, regardless of gender;
- Stable coronary artery disease, unstable angina, or acute myocardial infarction (AMI ≥ 7 days);
- Coronary angiography showed primary lesions with a visual stenosis of 30% to 90% in at least two coronary arteries ≥ 2.5 mm in diameter;
- Willing to participate in the study and able to understand, read, and sign the informed consent form.
Exclusion
- STEMI as clinical presentation within 7 days;
- Chronic Total Occlusion (CTO) as target vessel;
- Significant contraindication to adenosine administration (e.g., atrioventricular block, severe asthma, etc.);
- Study participants are currently participating in other drug or device clinical studies and have not achieved the study endpoints;
- Pregnant or nursing;
- Other situations considered by the investigator as unsuitable for participation in this study.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT07176585
Start Date
September 1 2025
End Date
December 1 2026
Last Update
September 16 2025
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