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Laser heart procedure under watch: 500 patients to be tracked

NCT ID NCT07348341

Knowledge-focused Sponsor: Ceric Sàrl 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Updated 2 times

Summary

This study will observe 500 adults with stable or acute heart artery disease who receive a laser treatment called Excimer Laser Coronary Atherectomy (ELCA) during a standard procedure to open blocked arteries. The goal is to track how well the laser works and how safe it is by recording success rates and any heart-related problems in the hospital. Participants must be 18 or older and have suitable blockages for the laser.

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 500 people

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

Started

Jul 2026

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with stable coronary artery disease or acute coronary syndromes who will be treated with excimer laser coronary atherectomy (ELCA)

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 will be included if all the following criteria are met: 1. Age 18 years or over 2. Patient willing to be included in the registry 3. Patients with stable coronary artery disease or acute coronary syndromes with de-novo or intra-stent restenosis (ISR) coronary lesions suitable to be treated with ELCA * Non-Crossable with ICI catheter or: * Crossable with ICI catheter with significant calcium score suggesting need for calcium modification based on IVUS or OCT criteria and/or * Non-Dilatable with 1:1 NC balloon 4. Mandated use of ICI: * Attempted before use of ELCA or * Following ELCA and any other calcium modification strategy utilized (to evaluate whether the additional modification demonstrates significant additional modification of the calcium on ICI) * Final after DES implantation or prior to use of DCB 5. Declared PCI strategy (planned use of ELCA, need for IVL/specialty balloons/alternative atherectomy and stent strategy) prior to PCI procedure Exclusion Criteria: 1. Pregnant or breast feeding 2. Unable to give informed consent 3. PCI performed without IVCI attempt 4. No ELCA use 5. Allergy to clopidogrel, prasugrel or ticagrelor or non-compliance 6. Post- cardiac arrest or haemodynamic instability 7. Participation in another trial.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder

As listed by the trial registrant

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

Acute coronary syndromes Stable coronary artery disease

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

  • La Paz Universtity Hospital

    RECRUITING

    Madrid, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.