Excimer Laser Coronary Atherectomy (ELCA): ELCA treat a significant coronary stenosis or recanalize occluded coronary arteries using UV during percutaneous coronary intervention.
Study summary
This study is a prospective, investigator-initiated, multi-center, single arm, observational registry of performance of Excimer Laser Coronary Atherectomy (ELCA) in standard use cases of percutaneous coronary intervention (PCI).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Procedural success during index PCI — During Procedure The primary endpoint of efficacy is procedural Success during index PCI:, which is a combined endpoint of these following events:
* Angiographic success defined as residual stenosis \<30% in two orthogonal projections after lesion treatment with ELCA destination therapy with DES or DCB
* TIMI 3 flow and absence of ELCA related complications during the procedure
* Intra-Coronary Imaging success defined as final MSA \> 5.5mm2 IVUS or 4.5mm2 OCT with \> 80% stent expansion - site reported
Freedom from in hospital Major Adverse Cardiovascular Events — Periprocedural The primary endpoint of safety is freedom from in-hospital Major Adverse Cardiovascular Events (MACE), including : cardiac death, target vessel myocardial infarction (TVMI), urgent repeat target vessel revascularization (TVR) with either PCI or CABG, and Stroke.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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