New heart test could replace painful procedure – no extra wires needed!
NCT ID NCT07446023
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new technology called IVUS-FFR that uses ultrasound images from inside heart arteries to quickly check if a blockage is serious enough to need a stent. Unlike the current standard test, it doesn't require an extra pressure wire or medication that can cause discomfort. About 292 adults with suspected heart artery disease will have both the new and standard tests to see if the new method is just as accurate.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 292 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fuwai hospital
RECRUITINGBeijing, Beijing Municipality, 100037, China
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Other studies related to the condition(s) this trial covers.
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