Stable Coronary Artery DiseaseCLARITNCT07348341
Coronary Laser Atherectomy Registry From an International Taskforce
An observational study of Stable Coronary Artery Disease and Acute Coronary Syndromes, run by Ceric Sàrl at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Coronary Artery Disease, Acute Coronary Syndromes
- What is being tested?
- Excimer Laser Coronary Atherectomy (ELCA)
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jul 2026to 30 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable coronary artery disease or acute coronary syndromes who will be treated with excimer laser coronary atherectomy (ELCA)
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
La Paz Universtity Hospital
Madrid
Alfonso Jurado Roman, +34 629871863, alfonsojuradoroman@gmail.com
About this study
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).
Read the 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.
- Being tested
- Excimer Laser Coronary Atherectomy (ELCA)
- Keywords
- excimer laser coronary atherectomy, ELCA, CLARIT, coronary artery disease, acute coronary syndromes
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excimer Laser Coronary Atherectomy (ELCA)Device
ELCA treat a significant coronary stenosis or recanalize occluded coronary arteries using UV during percutaneous coronary intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Periprocedural
Secondary outcomes (30)
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).
Measured: 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
Measured: 30 days and 1 year
Procedural Characteristic- Cost
Procedural costs (devices used)
Measured: During procedure
Procedural Characteristic- Device success based on maximum fluence
Device Success based on maximum fluence
Measured: During procedure
Procedural Characteristic- Fluoroscopy Time
Fluoroscopy time
Measured: During procedure
Procedural Characteristic- Contrast Volume
Contrast Volume
Measured: During procedure
Procedural characteristic- Device success based on repetition rate
Device Success based on repetition rate
Measured: During procedure
Procedural characteristic- Device success based on pulses number
Device Success based on number of pulses
Measured: During procedure
Procedural characteristic- Device success based on lasing duration
Device Success in relation to the duration of lasing
Measured: During Procedure
Procedural characteristic- Device success based on laser trains number
Device Success in relation to the number of laser trains
Measured: During procedure
Procedural characteristic- Catheter access
Catheter access : radial or femoral
Measured: During Procedure
Requirement of hemodynamic support
composite of need for pharmacological or mechanical hemodynamic support
Measured: During procedure
Marker of the learning curve associated with ELCA- Total procedure time
The total time of the procedure
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: During procedure
Impact on catheter lab workflow- Procedural duration
Procedural duration for decision of ELCA to passage of Intracoronary imaging or ballon
Measured: During procedure
Intracoronary imaging analysis by the site- Calcium morphology
Calcium morphology (concentric, eccentric or nodular) reported by the site.
Measured: During procedure
Intracoronary imaging analysis by the site- Depth of lesion calcification
Depth of lesion calcification reported by the site.
Measured: During procedure
Intracoronary imaging analysis by the site- Lesion calcification length
Length of lesion calcification reported by the site
Measured: During procedure
Intracoronary imaging analysis by the CoreLab
calcium burden (%)
Measured: During procedure
Intracoronary imaging analysis by the CoreLab
calcium depth (mm)
Measured: During Procedure
Intracoronary imaging analysis by the CoreLab
impact of OAS and other devices on calcium
Measured: During procedure
Intracoronary imaging analysis by the CoreLab
minimal stent area (mm²)
Measured: during procedure
Intracoronary imaging analysis by the CoreLab
stent expansion (%)
Measured: During Procedure
Intracoronary imaging analysis by the CoreLab
presence of edge dissection
Measured: During Procedure
Intracoronary imaging analysis by the CoreLab
presence of stent malposition
Measured: During procedure
Intracoronary imaging analysis by the CoreLab
maximal eccentricity index
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start20 Jul 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ceric SàrlThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips Medical Systems, European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Peter O'kane, Professor, Study chair, Dorset Heart Centre, The Royal Bournemouth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348341
- Sponsor's protocol ID
- PHI-01
- Acronym
- CLARIT
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Laser Atherectomy Registry From an International Taskforce
- ClinicalTrials.gov ID
- NCT07348341
- Acronym / sponsor ID
- CLARIT / PHI-01
- Keywords
- excimer laser coronary atherectomy, ELCA, CLARIT, coronary artery disease, acute coronary syndromes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ceric SàrlIndustry (pharma, biotech, devices)
- Collaborators
- Philips Medical Systems, European Cardiovascular Research Center
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable coronary artery disease or acute coronary syndromes who will be treated with excimer laser coronary atherectomy (ELCA)
Key inclusion criteria (12 listed)
- 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
- Mandated use of ICI:
- Declared PCI strategy (planned use of ELCA, need for IVL/specialty balloons/alternative atherectomy and stent strategy) prior to PCI procedure
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excimer Laser Coronary Atherectomy (ELCA)ELCA treat a significant coronary stenosis or recanalize occluded coronary arteries using UV during percutaneous coronary intervention. | Device | – |
Primary outcome
Procedural success during index PCI
Time frame: During Procedure
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
Freedom from in hospital Major Adverse Cardiovascular Events
Time frame: Periprocedural
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.
30 secondary outcomes
Composite endpoint of one of events reported
Time frame: 30 days and 1 year
Success of revascularization: Freedom from Target lesion failure (TLF) events and ICI assessed stent optimization
Time frame: 30 days and 1 year
Procedural Characteristic- Cost
Time frame: During procedure
Procedural Characteristic- Device success based on maximum fluence
Time frame: During procedure
Procedural Characteristic- Fluoroscopy Time
Time frame: During procedure
Procedural Characteristic- Contrast Volume
Time frame: During procedure
Procedural characteristic- Device success based on repetition rate
Time frame: During procedure
Procedural characteristic- Device success based on pulses number
Time frame: During procedure
Procedural characteristic- Device success based on lasing duration
Time frame: During Procedure
Procedural characteristic- Device success based on laser trains number
Time frame: During procedure
Procedural characteristic- Catheter access
Time frame: During Procedure
Requirement of hemodynamic support
Time frame: During procedure
Marker of the learning curve associated with ELCA- Total procedure time
Time frame: During procedure
Marker of the learning curve associated with ELCA- Intra-procedural interval from ELCA decision to post-ELCA intracoronary imaging
Time frame: During procedure
Marker of the learning curve associated with ELCA- Number of ECLA trains
Time frame: During procedure
Marker of the learning curve associated with ELCA- Milieu type used during lasing
Time frame: During procedure
Impact on catheter lab workflow- Lesion preparation strategy
Time frame: During procedure
Impact on catheter lab workflow- Stent Strategy
Time frame: During procedure
Impact on catheter lab workflow- Procedural duration
Time frame: During procedure
Intracoronary imaging analysis by the site- Calcium morphology
Time frame: During procedure
Intracoronary imaging analysis by the site- Depth of lesion calcification
Time frame: During procedure
Intracoronary imaging analysis by the site- Lesion calcification length
Time frame: During procedure
Intracoronary imaging analysis by the CoreLab
Time frame: During procedure
Intracoronary imaging analysis by the CoreLab
Time frame: During Procedure
Intracoronary imaging analysis by the CoreLab
Time frame: During procedure
Intracoronary imaging analysis by the CoreLab
Time frame: during procedure
Intracoronary imaging analysis by the CoreLab
Time frame: During Procedure
Intracoronary imaging analysis by the CoreLab
Time frame: During Procedure
Intracoronary imaging analysis by the CoreLab
Time frame: During procedure
Intracoronary imaging analysis by the CoreLab
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter O'kane, Professor study chair
Dorset Heart Centre, The Royal Bournemouth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Coronary Artery Disease and Acute Coronary Syndromes, run by Ceric Sàrl at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie FAURE (+33 (0)675574485, jfaure@cerc-europe.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success during index PCI (time frame: During Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.