Acute Coronary Syndromes, Stable Coronary Artery Disease
Conditions
Keywords
excimer laser coronary atherectomy, ELCA, CLARIT, coronary artery disease, acute coronary syndromes
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.
Interventions
DEVICEExcimer Laser Coronary Atherectomy (ELCA)
ELCA treat a significant coronary stenosis or recanalize occluded coronary arteries using UV during percutaneous coronary intervention.
Sponsors
Ceric Sàrl
Philips Medical Systems
European Cardiovascular Research Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success during index PCI | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of one of events reported | 30 days and 1 year | 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). |
| Success of revascularization: Freedom from Target lesion failure (TLF) events and ICI assessed stent optimization | 30 days and 1 year | 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 |
| Procedural Characteristic- Cost | During procedure | Procedural costs (devices used) |
| Procedural Characteristic- Device success based on maximum fluence | During procedure | Device Success based on maximum fluence |
| Procedural Characteristic- Fluoroscopy Time | During procedure | Fluoroscopy time |
| Procedural Characteristic- Contrast Volume | During procedure | Contrast Volume |
| Procedural characteristic- Device success based on repetition rate | During procedure | Device Success based on repetition rate |
| Procedural characteristic- Device success based on pulses number | During procedure | Device Success based on number of pulses |
| Procedural characteristic- Device success based on lasing duration | During Procedure | Device Success in relation to the duration of lasing |
| Procedural characteristic- Device success based on laser trains number | During procedure | Device Success in relation to the number of laser trains |
| Procedural characteristic- Catheter access | During Procedure | Catheter access : radial or femoral |
| Requirement of hemodynamic support | During procedure | composite of need for pharmacological or mechanical hemodynamic support |
| Marker of the learning curve associated with ELCA- Total procedure time | During procedure | The total time of the procedure |
| Marker of the learning curve associated with ELCA- Intra-procedural interval from ELCA decision to post-ELCA intracoronary imaging | During procedure | The time between the decision for ELCA to the uses of Intracoronary imaging after ELCA. |
| Marker of the learning curve associated with ELCA- Number of ECLA trains | During procedure | The number of ELCA trains, including the number of pulses, settings performed by the clinician. |
| Marker of the learning curve associated with ELCA- Milieu type used during lasing | During procedure | The type of milieu used during lasing (blood, saline or contrast) |
| Impact on catheter lab workflow- Lesion preparation strategy | During procedure | 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). |
| Impact on catheter lab workflow- Stent Strategy | During procedure | The change of stent strategy (after ELCA and subsequent ICI) compared to the operator's initial upfront declared strategy. |
| Impact on catheter lab workflow- Procedural duration | During procedure | Procedural duration for decision of ELCA to passage of Intracoronary imaging or ballon |
| Intracoronary imaging analysis by the site- Calcium morphology | During procedure | Calcium morphology (concentric, eccentric or nodular) reported by the site. |
| Intracoronary imaging analysis by the site- Depth of lesion calcification | During procedure | Depth of lesion calcification reported by the site. |
| Intracoronary imaging analysis by the site- Lesion calcification length | During procedure | Length of lesion calcification reported by the site |
| Intracoronary imaging analysis by the CoreLab | During procedure | calcium burden (%) |
Countries
Spain
Contacts
CONTACTJulie FAURE
CONTACTPhani Kondamudi
STUDY_CHAIRPeter O'kane, Professor
Dorset Heart Centre, The Royal Bournemouth Hospital
Outcome results
None listed