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Heart artery study tests which tool best protects tiny vessels

NCT ID NCT06507449

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Upper Silesian Medical Centre

    Katowice, 40-081, Poland

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