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New heart device aims to clear toughest blockages

NCT ID NCT06736899

Disease control Sponsor: Fundación EPIC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Updated 2 times

Summary

This study tests if a special device called orbital atherectomy can better prepare hardened (calcified) heart artery blockages for stenting compared to standard balloon treatment. About 200 adults with severe blockages will be randomly assigned to one of two groups. The goal is to see which approach leads to safer and more effective stent placement.

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 200 people

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

Started

Oct 2025

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: * Patients over 18 years of age and * Patients with moderately or severely calcified bifurcation lesions (lateral vessel ≥ 2mm), candidates for PCI with coronary stent implantation, in whom there is the possibility of adequate clinical follow-up at 1 year and * Patients agree to participate in the study, by signing the Informed Consent. Exclusion Criteria: * Patients with revascularization of the artery to be treated within 9 months prior to the index procedure. * Patients with contraindication for the use of Orbital Atherectomy: * Patients in cardiogenic shock. * Patients with Thrombotic lesions. * Patients with Vascular graft disease. * Patients with remain vessel disease. * Patients with severe left ventricular dysfunction. * Patients allergic to the components of the washing serum (glide). * Patients with life expectancy less than one year.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Coronary Disease

As listed by the trial registrant

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

Coronary artery disease Coronary disease

How to take part

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

  1. The places running it

    9 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

  • H. G.U. de ALICANTE DR. BALMIS

    RECRUITING

    Alicante, 03010, Spain

  • H. de La Santa Creu I Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Hospital Del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Hospital Universitari de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital Universitario La Luz

    RECRUITING

    Madrid, 28003, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Fuencarral-El Pardo, 28046, Spain

  • Hospital Universitario Lucus Augusti

    RECRUITING

    Lugo, 270003, Spain

  • Hospital Universitario Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

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