NCT07446023 IVUS-FFR Accuracy for Coronary Stenosis
| NCT ID | NCT07446023 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Percutaneous Coronary Intervention |
| Study Type | INTERVENTIONAL |
| Enrollment | 292 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 292 participants in total. It began in 2025-07-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria General Requirements * 18 years of age Diagnosed with stable/unstable angina or post-acute phase myocardial infarction (\>72 hours after onset) Able to comprehend study design and provide written informed consent Angiographic \& IVUS-Specific Requirements * 1 epicardial coronary artery with 30%-90% visual diameter stenosis Reference vessel diameter ≥2.0 mm at target stenosis site Exclusion Criteria General Exclusions Contraindications to invasive procedures/FFR per operator judgment Acute myocardial infarction within 72 hours Cardiogenic shock or severe heart failure (NYHA class ≥III or LVEF \<30%) Severe renal dysfunction (Creatinine \>150 μmol/L or eGFR \<45 mL/min/1.73m²) Allergy to iodinated contrast media or adenosine Pregnancy/lactation Life expectancy \<1 year Concurrent participation in other interventional trials Angiographic \& IVUS-Specific Exclusions Myocardial bridging at target lesion Severely calcified or tortuous vessels precluding safe IVUS Isolated \>90% stenosis with TIMI flow grade \<3 in major epicardial artery Other conditions deemed unsuitable for IVUS/FFR by investigators
Contact & Investigator
Kefei Dou, MD
STUDY CHAIR
Chinese Academy of Medical Sciences and Peking Union Medical College
Frequently Asked Questions
Who can join the NCT07446023 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Percutaneous Coronary Intervention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07446023 currently recruiting?
Yes, NCT07446023 is actively recruiting participants. Contact the research team at drdoukefei@126.com for enrollment information.
Where is the NCT07446023 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07446023 clinical trial?
NCT07446023 is sponsored by China National Center for Cardiovascular Diseases. The principal investigator is Kefei Dou, MD at Chinese Academy of Medical Sciences and Peking Union Medical College. The trial plans to enroll 292 participants.