Coronary Laser Atherectomy Registry From an International Taskforce
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCeric Sàrl
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Crossable with ICI catheter with significant calcium score suggesting need for calcium modification based on IVUS or OCT criteria and/or
Disqualifiers
Pregnant or breast feeding
Unable to give informed consent
PCI performed without IVCI attempt
No ELCA use
Trial population
Patients with stable coronary artery disease or acute coronary syndromes who will be treated with excimer laser coronary atherectomy (ELCA)
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Excimer Laser Coronary Atherectomy (ELCA)
DeviceELCA treat a significant coronary stenosis or recanalize occluded coronary arteries using UV during percutaneous coronary intervention.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 Procedure2
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
PeriproceduralSecondary outcomes
1
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 year2
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 year3
Procedural Characteristic- Cost
Procedural costs (devices used)
Time frame
During procedure4
Procedural Characteristic- Device success based on maximum fluence
Device Success based on maximum fluence
Time frame
During procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ceric Sàrl
Lead sponsor
Philips Medical Systems
Collaborator
European Cardiovascular Research Center
Collaborator
Source ClinicalTrials.gov