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

NCT ID: NCT07176585

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-23
• Study Completion Date: 2026-01-04

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

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: collaborator

Insight Lifetech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai Hospital,Cams & Pumc

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CIP-0201

Identifier Type: -

Identifier Source: org_study_id