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| Name | Class |
|---|---|
| Philips Medical Systems | INDUSTRY |
| European Cardiovascular Research Center | NETWORK |
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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excimer Laser Coronary Atherectomy (ELCA) | Device | ELCA treat a significant coronary stenosis or recanalize occluded coronary arteries using UV during percutaneous coronary intervention. |
| 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:
| 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 |
| 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 |
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Inclusion Criteria:
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
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
Exclusion Criteria:
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Patients with stable coronary artery disease or acute coronary syndromes who will be treated with excimer laser coronary atherectomy (ELCA)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie FAURE | Contact | +33 (0)675574485 | jfaure@cerc-europe.org | |
| Phani Kondamudi | Contact | +33 (0)6 60 05 55 12 | pkondamudi@cerc-europe.org |
| Name | Affiliation | Role |
|---|---|---|
| Peter O'kane, Professor | Dorset Heart Centre, The Royal Bournemouth Hospital | Study Chair |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 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 |
| D003327 |
| Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |