IVUS-FFR Accuracy for Coronary Stenosis
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)
| Condition(s) | Percutaneous Coronary Intervention, Intravenous Ultrasound, Coronary Physiology |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 perf |
| Who can participate | 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 Con |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | China National Center for Cardiovascular Diseases |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2025-07-01 |
| NCT ID | NCT07446023 |
| Official listing | https://clinicaltrials.gov/study/NCT07446023 |