Overview
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).
Description
The primary objective of the CLARIT study is to assess the Safety and Efficacy of ELCA in recognized indications for the device at Index PCI and during the in-hospital stay. The secondary objectives includes the safety and efficacy of ELCA at 30 days and 1 year, as well as the procedural characteristics for the assessment of the learning curve and impact on the catheter lab workflow.
500 patients will be included in 20 sites accorss 8 countries in Europe, United Kingdom and India. The patients included in the study according to eligibility criteria will be followed up one year. The total study duration is 3 years, including 2 years of recruitment.
The follow-up/visit windows include the screening/baseline period, on the day of procedure, discharge; 1 month and 1 year follow-up. The ELCA is to be used following Instruction for uses and follow-up as per hospital standard of care.
Eligibility
Inclusion Criteria:
Subjects will be included if all the following criteria are met:
- Age 18 years or over
- Patient willing to be included in the registry
- 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
- 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
- Declared PCI strategy (planned use of ELCA, need for IVL/specialty balloons/alternative atherectomy and stent strategy) prior to PCI procedure
Exclusion Criteria:
- Pregnant or breast feeding
- Unable to give informed consent
- PCI performed without IVCI attempt
- No ELCA use
- Allergy to clopidogrel, prasugrel or ticagrelor or non-compliance
- Post- cardiac arrest or haemodynamic instability
- Participation in another trial.
