What is this study testing for coronary artery disease?

This study is evaluating a new technology called IVUS-FFR that uses ultrasound imaging to measure if narrowed heart arteries reduce blood flow. Researchers want to see if IVUS-FFR can provide accurate results like the current standard test but faster and without extra wires or medication. The study is led by heart specialists at China's National Center for Cardiovascular Diseases.

Who may be eligible for this coronary artery disease clinical trial?

Adults aged 18 years or older with stable or unstable angina or more than 72 hours after a heart attack may be eligible. Participants need at least one artery narrowing between 30% and 90%. People with severe kidney or heart failure or who are pregnant cannot join. Please review eligibility criteria for more details.

Is there any cost to participate in this coronary artery disease clinical trial?

Study-related care, including the imaging tests and all trial visits, is provided at no cost. Personal travel expenses to and from the study site may vary and are not guaranteed to be covered. Participants can expect standard care procedures combined with additional imaging during their hospital visit.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07446023

Diagnostic Accuracy of Intravascular Ultrasound-Derived Fractional Flow Reserve for Online Assessment of Functionally Significant Coronary Stenosis A Multicenter Prospective Study

Led by China National Center for Cardiovascular Diseases · Updated on 2026-03-03

292

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new technology called IVUS-FFR that uses ultrasound imaging inside heart arteries to quickly measure if a narrowed artery is affecting blood flow. This study focuses on adults with suspected or known coronary artery disease who have at least one artery narrowing between 30 and 90. The goal is to validate the accuracy of IVUS-FFR compared to the current standard test, FFR, which involves pressure wires and medication but can cause discomfort and complications. Participants will undergo a standard heart artery imaging procedure angiogram along with intravascular ultrasound IVUS imaging using a 40MHz catheter. The IVUS images are analyzed immediately by specialized software to estimate blood flow without extra wires or medication. This is followed by the conventional FFR test for comparison. The entire process adds less than 10 minutes to routine care and uses approved devices. The study is designed to assess the diagnostic accuracy of IVUS-FFR in real-time clinical settings. During the study, participants will have coronary angiography, IVUS image capture, computational analysis, and FFR measurement. The researchers will measure the diagnostic accuracy of IVUS-FFR in identifying significant artery narrowing during the catheterization procedure. Safety monitoring includes standard risks of heart catheterization and minimal additional risk from the IVUS and FFR steps. The study plans to enroll 292 adults and is conducted across multiple hospitals in China with ethical oversight. Participation involves a single assessment at the time of the cardiac catheterization.

CONDITIONS

Brief Title

IVUS-FFR Accuracy for Coronary Stenosis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

18 years of age or older
Diagnosed with stable or unstable angina, or more than 72 hours after a heart attack
Able to understand the study and provide written consent
At least one epicardial coronary artery with 30%-90% diameter narrowing
Reference vessel diameter of 2.0 mm or larger at the narrowed site

You will not qualify if you...

Acute myocardial infarction within 72 hours
Cardiogenic shock or severe heart failure (NYHA class III or higher, or left ventricular ejection fraction below 30%)
Severe kidney dysfunction (Creatinine over 150 micromol/L or estimated glomerular filtration rate below 45 mL/min/1.73m²)
Allergy to iodinated contrast media or adenosine
Pregnancy or breastfeeding
Life expectancy less than 1 year
Participation in other interventional trials
Myocardial bridging at the target lesion
Severely calcified or tortuous vessels preventing safe IVUS
Isolated artery narrowing greater than 90% with reduced blood flow (TIMI flow grade less than 3)
Other conditions unsuitable for IVUS or FFR as judged by investigators

Research Team

Kefei Dou, Principal Investigator

Zhihao Zheng, MD

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