Coronary Laser Atherectomy Registry in an International Network
Official title: Coronary Laser Atherectomy Registry From an International Taskforce
Run by Ceric Sàrl · NCT07348341 · Data updated 2026-11-12
This registry tests how well Excimer Laser Coronary Atherectomy (ELCA) works in real-world PCI for people with stable or acute coronary conditions across multiple countries.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Ceric Sàrl Industry-sponsored |
| Locations | 1 site (Madrid) |
| Status | Recruiting |
| Started | July 20, 2026 |
| Main results expected | July 30, 2028 |
| Study ends | July 30, 2029 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07348341 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older with stable CAD or ACS suitable for ELCA, including de-novo or intra-stent restenosis lesions needing calcium modification per imaging criteria.
✕Probably not a fit
Patients with lesions not treatable by ELCA or without appropriate calcium modification indications may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, investigator-initiated, multi-center, single-arm observational registry evaluating the safety and efficacy of ELCA in standard PCI use. Primary goals assess ELCA performance during index PCI and in-hospital stay; secondary goals look at outcomes at 30 days and 1 year, plus how the procedure learning curve and catheter lab workflow are affected. About 500 patients will be enrolled across 20 sites in 8 countries over three years, with follow-up at baseline, procedure day, discharge, 1 month, and 1 year. ELCA is used according to hospital standard of care and device labeling. Eligibility includes adults with stable CAD or ACS with lesions suitable for ELCA, and an explicit PCI strategy and calcium modification criteria. Primary sponsor is Ceric Sàrl, with collaborators including Philips Medical Systems and European Cardiovascular Research Center.
Why it matters
Potential benefit: If successful, the study could clarify ELCA’s safety and effectiveness for complex calcium-rich lesions and inform best practices in PCI workflows.
How similar studies have gone: Prior observational efforts have explored ELCA in PCI, but this registry aims to broaden international data and real-world practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
La Paz Universtity Hospital
Madrid, Spain Recruiting
Study contacts
- Study coordinator: Julie FAURE
- Email: jfaure@cerc-europe.org
- Phone: +33 (0)675574485
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.