Coronary Laser Atherectomy Registry From an International Taskforce

N/ANot Yet RecruitingNCT07348341

Ceric Sàrl500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Stable Coronary Artery Disease Acute Coronary Syndromes

Interventions

Excimer Laser Coronary Atherectomy (ELCA)DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: Periprocedural

Secondary Outcomes

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).

Time frame: 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

Time frame: 30 days and 1 year

Procedural Characteristic- Cost

Procedural costs (devices used)

Time frame: During procedure

Central Contacts

Julie FAURE

CONTACT

+33 (0)675574485 jfaure@cerc-europe.org

Phani Kondamudi

CONTACT

+33 (0)6 60 05 55 12 pkondamudi@cerc-europe.org

Data from ClinicalTrials.gov

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Procedural Characteristic- Device success based on maximum fluence

Device Success based on maximum fluence

Time frame: During procedure

Procedural Characteristic- Fluoroscopy Time

Fluoroscopy time

Time frame: During procedure

Procedural Characteristic- Contrast Volume

Contrast Volume

Time frame: During procedure

Procedural characteristic- Device success based on repetition rate

Device Success based on repetition rate

Time frame: During procedure

Procedural characteristic- Device success based on pulses number

Device Success based on number of pulses

Time frame: During procedure

Procedural characteristic- Device success based on lasing duration

Device Success in relation to the duration of lasing

Time frame: During Procedure

Procedural characteristic- Device success based on laser trains number

Device Success in relation to the number of laser trains

Time frame: During procedure

Procedural characteristic- Catheter access

Catheter access : radial or femoral

Time frame: During Procedure

Requirement of hemodynamic support

composite of need for pharmacological or mechanical hemodynamic support

Time frame: During procedure

Marker of the learning curve associated with ELCA- Total procedure time

The total time of the procedure

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 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).

Time frame: 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.

Time frame: During procedure

Impact on catheter lab workflow- Procedural duration

Procedural duration for decision of ELCA to passage of Intracoronary imaging or ballon

Time frame: During procedure

Intracoronary imaging analysis by the site- Calcium morphology

Calcium morphology (concentric, eccentric or nodular) reported by the site.

Time frame: During procedure

Intracoronary imaging analysis by the site- Depth of lesion calcification

Depth of lesion calcification reported by the site.

Time frame: During procedure

Intracoronary imaging analysis by the site- Lesion calcification length

Length of lesion calcification reported by the site

Time frame: During procedure