Coronary Laser Atherectomy Registry From an International Taskforce

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

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.

Conditions3

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