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

Diagnostic Accuracy of Intravascular Ultrasound-Derived Fractional Flow Reserve for Online Assessment of Functionally Significant Coronary Stenosis: A Multicenter Prospective Study

This study tests whether an IVUS-derived software can quickly tell if a narrowed coronary artery is reducing blood flow in adults having coronary angiography, without using pressure wires or vasodilator drugs.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 292 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (other gov)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07446023 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) undergoing coronary angiography with a single epicardial target lesion of 30%–90% stenosis and reference vessel diameter ≥2.0 mm who can give informed consent are ideal candidates.

Not a fit: Patients with recent myocardial infarction within 72 hours, cardiogenic shock or severe heart failure, severe renal dysfunction, heavy vessel calcification or tortuosity that prevents safe IVUS, small target vessels (<2.0 mm), or contraindications to invasive angiography are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, IVUS-FFR could provide similarly accurate blood-flow information faster, more comfortably, and at lower cost by avoiding pressure wires and vasodilator drugs.

How similar studies have performed: Image-derived FFR methods (from angiography or intravascular imaging) have shown promising results in prior work, but IVUS-FFR remains an emerging technique that requires further validation against pressure-wire FFR.

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

Where this trial is running

Beijing, Beijing Municipality

• Fuwai hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Kefei Dou, Principal Investigator

Conditions: Percutaneous Coronary Intervention, Intravenous Ultrasound, Coronary Physiology, Fractional Flow Reserve, IVUS-FFR, Diagnostic Accuracy