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Recruiting NCT07348341

Coronary Laser Atherectomy Registry From an International Taskforce

Conditions: Stable Coronary Artery Disease, Acute Coronary Syndromes

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 500
Sponsor: Ceric Sàrl

Location: La Paz Universtity Hospital Madrid

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07348341). StuddyBuddy aggregates publicly available trial information.