IVUS-based ultrasound method to measure blood flow through narrowed coronary arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing coronary angiography with a 30%–90% visual stenosis will have intravascular ultrasound (IVUS) pulled through the target artery to acquire images that are analyzed in real time by an IVUS-FFR computational system. The IVUS-FFR result will be compared against standard pressure-wire fractional flow reserve (FFR) measurements to determine diagnostic accuracy. Secondary goals include testing feasibility in the cath lab and establishing standardized acquisition and analysis protocols. Standard angiographic and clinical exclusion criteria (recent MI <72 hours, severe renal dysfunction, cardiogenic shock, severe vessel calcification or tortuosity, contrast or adenosine allergy) are applied to ensure patient safety.

Why it matters

Who can join: the full rules

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

Where it's running

• Fuwai hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Kefei Dou, Principal Investigator
• Email: drdoukefei@126.com
• Phone: 15980609858

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.