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

COMPLETED

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

NCT07176585•Insight Lifetech Co., Ltd.

View on ClinicalTrials.gov

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 ischemia, using coronary fractional flow reserve (FFR) as the gold standard.

Eligibility

Age

18 - 80 years

Sex

ALL

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.

Locations (1)

Fuwai Hospital,Cams & Pumc

Beijing, Beijing Municipality, China

Key Dates

Start Date

September 23, 2025

Primary Completion Date

January 4, 2026

Completion Date

January 4, 2026

Last Updated

January 26, 2026

Enrollment

105

ACTUAL participants

Conditions

Coronary Artery Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

"Erectile Function After PCI in MI and Non-MI Patients"

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