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Heart calcium showdown: which device wins?

NCT ID NCT06736665

Disease control Sponsor: Spanish Society of Cardiology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two medical devices used to break up hard calcium deposits in heart arteries before placing a stent. It involves 50 adults with coronary artery disease who will be randomly assigned to receive either orbital atherectomy or intravascular lithotripsy. The goal is to see which technique leads to better stent placement and fewer complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Orbital atherectomy device or intravascular lithotripsy device
What this could lead to
If this trial succeeds, it could show which device is safer and more effective for treating tough calcium deposits in heart arteries, improving outcomes for patients.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply to everyone. Both procedures carry risks like vessel damage or heart attack.

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 50 people

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

Started

Jun 2025

Expected to finish

Dec 2027

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: 1. Patients aged ≥ 18 years. 2. Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization. 3. Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation\*. 4. Distal vessel reference diameters ≥ 2.5 mm and ≤ 4.0 mm. \* Non-culprit lesions eligible for revascularization in a staged procedure following a ST-elevation myocardial infarction (STEMI) are considered for inclusion. Exclusion Criteria: 1. Culprit lesions in acute coronary syndrome with ST elevation. 2. Left main disease. 3. In-stent restenosis lesions. 4. Critical stenoses where it is not possible to advance the OCT catheter across the lesion after predilation with a balloon of up to 2 mm in diameter. 5. Lesion involving a bifurcation with a secondary branch diameter ≥2 mm. 6. Cardiogenic shock. 7. Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty. 8. Pregnancy. 9. Life expectancy of less than one year. 10. Contraindication for the use of appropriate antiplatelet therapy post-revascularization. 11. Coronary artery disease with an indication for surgical revascularization. 12. Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography. 13. Inability to obtain informed consent. 14. Allergy to eggs or soy, contraindicating the use of OA.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute coronary syndrome (ACS) Chronic coronary syndrome Coronary arterial disease (CAD) Coronary calcification Coronary calcified nodules Intravascular lithotripsy Optical coherence tomography (OCT) Orbital atherectomy Percutaneous coronary intervention (PCI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Hospital Clínico Universitario de Valladolid

    RECRUITING

    Valladolid, Valladolid, 47003, Spain

  • Hospital Universitario General de Alicante

    RECRUITING

    Alicante, Alicante, 03010, Spain

  • Hospital Universitario Lucus Augusti

    RECRUITING

    Lugo, Lugo, 27003, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Reina Sofía de Córdoba

    RECRUITING

    Córdoba, Spain

  • Hospital Universitario de Salamanca

    RECRUITING

    Salamanca, Salamanca, 37007, Spain

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