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Massive registry to uncover best tactics for Rock-Hard arteries

NCT ID NCT07566403

Knowledge-focused Sponsor: Papa Giovanni XXIII Hospital Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This observational study will follow 3000 patients with severely calcified coronary arteries who undergo a procedure to open the blockages (PCI). Researchers will track outcomes like heart attacks and repeat procedures over time. The goal is to learn which techniques work best in everyday practice, especially for high-risk patients often left out of clinical trials.

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 registry could provide real-world evidence to guide doctors in choosing the best treatment approach for severely calcified coronary arteries, potentially improving patient outcomes.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection and real-world variability.

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.

Participants

About 3,000 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2036

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.

Who is studied

The OROBICA Registry will include adult patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary artery disease in routine clinical practice. The study population consists of all-comer patients treated for complex calcified coronary lesions, including individuals with stable coronary artery disease, acute coronary syndromes, multivessel disease, left main disease, bifurcation lesions, chronic total occlusions, and high-risk clinical or anatomical features.

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: * Patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary lesions, angiographically defined as radiopacities noted without cardiac motion before contrast injection, generally involving both sides of the arterial wall. * Patients undergoing PCI for calcified coronary lesions with intracoronary optical coherence tomography (OCT) showing at least one of the following features: * calcium arc ≥180° * calcium thickness ≥0.3 mm * calcium length ≥3 mm * presence of calcified nodules * Patients undergoing PCI for calcified coronary lesions with intravascular ultrasound (IVUS) showing at least one of the following features: * calcium arc ≥180° * concentric or superficial calcium with extensive acoustic shadowing * presence of calcified nodules Exclusion Criteria: * Lack of availability of essential clinical or procedural data. * Refusal or withdrawal of informed consent for the prospective component of the registry, when applicable. * Exercise of the right to object to data processing, according to applicable data protection regulations.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

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

Calcific coronary arteriosclerosis Coronary artery disease (CAD) Intravascular lithotripsy; rotational atherectomy; ofdi Intravascular ultrasound Optical coherence tomography (OCT) Orbital atherectomy Percutaneous coronary intervention

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

    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

  • ASST Papa Giovanni XXIII

    Bergamo, Bergamo, 24127, Italy

More trials for these conditions

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