Coronary Laser Atherectomy Registry From an International Taskforce (CLARIT)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Stable Coronary Artery Disease; Acute Coronary Syndromes
• Intervention / Treatment: Device: Excimer Laser Coronary Atherectomy (ELCA)

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Julie FAURE; Phone Number: +33 (0)675574485; Email: jfaure@cerc-europe.org
• Study Contact Backup: Name: Phani Kondamudi; Phone Number: +33 (0)6 60 05 55 12; Email: pkondamudi@cerc-europe.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with stable coronary artery disease or acute coronary syndromes who will be treated with excimer laser coronary atherectomy (ELCA)

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success during index PCI	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	During Procedure
Freedom from in hospital Major Adverse Cardiovascular Events	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.	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint of one of events reported	The secondary endpoint is a composite endpoint of one of these event : Major Adverse Cardiovascular Events (MACE) (including cardiac death, target vessel revascularization, myocardial infarction, target vessel myocardial infarction (TVMI), unplanned hospitalization of unstable angina).	30 days and 1 year
Success of revascularization: Freedom from Target lesion failure (TLF) events and ICI assessed stent optimization	This is defined by MSA stent expansion,stent apposition, full lesion coverage with < 50% plaque burden at proximal and distal references with TIMI 3 flow, no significant edge dissection	30 days and 1 year
Procedural Characteristic- Cost	Procedural costs (devices used)	During procedure
Procedural Characteristic- Device success based on maximum fluence	Device Success based on maximum fluence	During procedure
Procedural Characteristic- Fluoroscopy Time	Fluoroscopy time	During procedure
Procedural Characteristic- Contrast Volume	Contrast Volume	During procedure
Procedural characteristic- Device success based on repetition rate	Device Success based on repetition rate	During procedure
Procedural characteristic- Device success based on pulses number	Device Success based on number of pulses	During procedure
Procedural characteristic- Device success based on lasing duration	Device Success in relation to the duration of lasing	During Procedure
Procedural characteristic- Device success based on laser trains number	Device Success in relation to the number of laser trains	During procedure
Procedural characteristic- Catheter access	Catheter access : radial or femoral	During Procedure
Requirement of hemodynamic support	composite of need for pharmacological or mechanical hemodynamic support	During procedure
Marker of the learning curve associated with ELCA- Total procedure time	The total time of the procedure	During procedure
Marker of the learning curve associated with ELCA- Intra-procedural interval from ELCA decision to post-ELCA intracoronary imaging	The time between the decision for ELCA to the uses of Intracoronary imaging after ELCA.	During procedure
Marker of the learning curve associated with ELCA- Number of ECLA trains	The number of ELCA trains, including the number of pulses, settings performed by the clinician.	During procedure
Marker of the learning curve associated with ELCA- Milieu type used during lasing	The type of milieu used during lasing (blood, saline or contrast)	During procedure
Impact on catheter lab workflow- Lesion preparation strategy	The change in lesion preparation strategy compared to the operator's initial upfront declared strategy (uses of IVL, specialty balloons or other atherectomy device alongside ELCA).	During procedure
Impact on catheter lab workflow- Stent Strategy	The change of stent strategy (after ELCA and subsequent ICI) compared to the operator's initial upfront declared strategy.	During procedure
Impact on catheter lab workflow- Procedural duration	Procedural duration for decision of ELCA to passage of Intracoronary imaging or ballon	During procedure
Intracoronary imaging analysis by the site- Calcium morphology	Calcium morphology (concentric, eccentric or nodular) reported by the site.	During procedure
Intracoronary imaging analysis by the site- Depth of lesion calcification	Depth of lesion calcification reported by the site.	During procedure
Intracoronary imaging analysis by the site- Lesion calcification length	Length of lesion calcification reported by the site	During procedure
Intracoronary imaging analysis by the CoreLab	calcium burden (%)	During procedure
Intracoronary imaging analysis by the CoreLab	calcium depth (mm)	During Procedure
Intracoronary imaging analysis by the CoreLab	impact of OAS and other devices on calcium	During procedure
Intracoronary imaging analysis by the CoreLab	minimal stent area (mm²)	during procedure
Intracoronary imaging analysis by the CoreLab	stent expansion (%)	During Procedure
Intracoronary imaging analysis by the CoreLab	presence of edge dissection	During Procedure
Intracoronary imaging analysis by the CoreLab	presence of stent malposition	During procedure
Intracoronary imaging analysis by the CoreLab	maximal eccentricity index	During procedure

Collaborators and Investigators

• Sponsor: Ceric Sàrl
• Collaborators: European Cardiovascular Research Center; Philips Medical Systems
• Investigators: Study Chair: Peter O'kane, Professor, Dorset Heart Centre, The Royal Bournemouth Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2029

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: coronary artery disease; acute coronary syndromes; ELCA; excimer laser coronary atherectomy; CLARIT
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Acute Coronary Syndrome
• Other Study ID Numbers: PHI-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No