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IVUS-FFR Accuracy for Coronary Stenosis

RecruitingNAAges 18 Years - anyAllChina National Center for Cardiovascular Diseases
NCT07446023 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ2.0 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 โ‰ฅIII or LVEF \<30%) Severe renal dysfunction (Creatinine \>150 ฮผmol/L or eGFR \<45 mL/min/1.73mยฒ) 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
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What it tests

  • Ultrasound-Derived Fractional Flow Reserve Computational System
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Where

1 site
Fuwai hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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