Coronary Laser Atherectomy Registry From an International Taskforce

NCT ID: NCT07348341

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-04-30
• Study Completion Date: 2029-07-30

Brief 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).

Detailed 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.

Conditions

Stable Coronary Artery Disease; Acute Coronary Syndromes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Excimer Laser Coronary Atherectomy (ELCA)

ELCA treat a significant coronary stenosis or recanalize occluded coronary arteries using UV during percutaneous coronary intervention.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Medical Systems

INDUSTRY

Sponsor Role: collaborator

European Cardiovascular Research Center

NETWORK

Sponsor Role: collaborator

Ceric Sàrl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter O'kane, Professor

Role: STUDY_CHAIR

Dorset Heart Centre, The Royal Bournemouth Hospital

Central Contacts

Julie FAURE

Role: CONTACT

jfaure@cerc-europe.org

+33 (0)675574485

Phani Kondamudi

Role: CONTACT

pkondamudi@cerc-europe.org

+33 (0)6 60 05 55 12

Other Identifiers

PHI-01

Identifier Type: -

Identifier Source: org_study_id