Actively Recruiting
IVUS-FFR Accuracy for Coronary Stenosis
Led by China National Center for Cardiovascular Diseases · Updated on 2026-03-03
292
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
IVUS-FFR Online Accuracy for Coronary Stenosis What is this study testing? This study is testing a new technology called IVUS-FFR , which uses ultrasound imaging inside heart arteries (IVUS) to quickly measure whether a narrowed artery ( coronary stenosis ) is reducing blood flow. Unlike the current standard test (FFR), this new method doesn't require extra wires or medication to work. Why is this important? Many patients with heart artery narrowing need tests to decide if a stent is necessary. Current FFR tests involve inserting a pressure wire and giving medication (like adenosine) that can cause discomfort. IVUS-FFR could provide equally accurate results faster, cheaper, and more comfortably . What happens in the study? If you join: Standard heart artery imaging (angiogram) will be performed. An ultrasound probe (IVUS) will be moved through the artery to create detailed images. The new IVUS-FFR software will analyze these images immediately to estimate blood flow. For comparison, a standard FFR test (with pressure wire and medication) will also be done. All steps use existing approved devices and take \<10 extra minutes. Who can participate? Adults (≥18 years) with: Suspected or known heart artery disease At least one artery narrowing (30%-90% blocked) Excluded: Recent heart attack (\<72 hrs), severe kidney/heart failure, or pregnancy. What are the risks and benefits? Risks: Same as routine heart catheterization (bleeding, infection, artery injury). The IVUS and FFR steps add minimal extra risk. Benefits: No direct benefit, but results may improve future care by reducing need for invasive tests. Study goal: To validate if IVUS-FFR is as accurate as the current FFR standard in 292 patients across multiple hospitals in China. Who is running the study? Led by heart specialists at Fuwai Hospital (Beijing) - China's top cardiovascular center - with ethics committee oversight.
CONDITIONS
Official Title
IVUS-FFR Accuracy for Coronary Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with stable or unstable angina, or more than 72 hours after a heart attack
- Able to understand the study and give written consent
- At least one epicardial coronary artery with 30%-90% diameter narrowing
- Target artery diameter of at least 2.0 mm at the narrowed site
You will not qualify if you...
- Contraindications to invasive procedures or FFR as judged by the operator
- Heart attack within past 72 hours
- Cardiogenic shock or severe heart failure (NYHA class III or higher, or LVEF less than 30%)
- Severe kidney dysfunction (Creatinine over 150 µmol/L or eGFR under 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 target lesion
- Severely calcified or twisted vessels preventing safe IVUS
- Isolated narrowing over 90% with TIMI flow grade less than 3 in major arteries
- Other conditions unsuitable for IVUS or FFR as decided by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fuwai hospital
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
K
Kefei Dou, Principal Investigator
CONTACT
Z
Zhihao Zheng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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