Heart artery study tests which tool best protects tiny vessels
NCT ID NCT06507449
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at three ways to treat severely hardened heart arteries before placing a stent: using sound waves (lithotripsy), a high-pressure balloon, or a tiny rotating device (orbital atherectomy). The goal is to see how each method affects the small blood vessels in the heart. Thirty people with heart disease will be assigned to one of the three treatments, and doctors will measure blood flow and vessel resistance before and after the procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors choose the best technique to treat hardened arteries while protecting small heart vessels.
- What could go wrong
- This is a very small, early-stage study with only 30 people, so results may not apply to everyone. It measures short-term effects, not long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects with native coronary artery disease (including stable or unstable angina and NSTEMI) suitable for PCI. * The lesion must be crossable with the study guide wire. * The target vessel reference diameter must be ≥ 2.5mm and ≤ 4.0 mm. * The target lesion must have evidence of severe calcium deposit at the lesion site based on the protocol criterion. * Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures. * Male or female, age above or equal to 18 years at the time of signing informed consent. Further inclusion criteria may apply Exclusion Criteria: * Inability to understand the study or a history of non-compliance with medical advice. * Unwilling or unable to sign the Informed Consent Form (ICF). * History of any cognitive or mental health status that would interfere with trial participation. * Male or female, age under 18 years at the time of signing informed consent. * Female subjects who are pregnant or planning to become pregnant within the study period. * Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated. * Subject has evidence of an active infection on the day of the procedure requiring oral or intravenous antibiotics. * Limited long term prognosis due to other conditions. * Subjects in cardiogenic shock or with decompensated heart failure (NYHA class IV). * Subject diagnosed with chronic kidney disease stage 4 or greater (eGFR \<30). * Most recent left ventricular ejection fraction ≤ 20%. * Subject is an acceptable candidate for coronary artery bypass surgery. * The target vessel reference diameter is under 2.0 mm. * Target lesion is located in or supplied by an arterial or venous bypass graft. * The target vessel has angiographically visible or suspected thrombus. * The target lesion is in an in-stent restenosis. * Subject has received a heart transplant. * Subject has major valve disease and underwent intervention within 30 days prior to randomization. Further exclusion criteria may apply
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Upper Silesian Medical Centre
Katowice, 40-081, Poland
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Other studies related to the condition(s) this trial covers.
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