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Recruiting NCT07348341

Coronary Laser Atherectomy Registry From an International Taskforce

— Observational Stable Coronary Artery Disease Acute Coronary Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Excimer Laser Coronary Atherectomy (ELCA).
Who it may be relevant to
Registry conditions: Stable Coronary Artery Disease, Acute Coronary Syndromes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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).

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

  • Device Excimer Laser Coronary Atherectomy (ELCA)
    ELCA treat a significant coronary stenosis or recanalize occluded coronary arteries using UV during percutaneous coronary intervention.

Primary outcome measures

  • Procedural success during index PCI [Time frame: During Procedure]
  • Freedom from in hospital Major Adverse Cardiovascular Events [Time frame: Periprocedural]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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
  • 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
  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Spain · 1 center
  • La Paz Universtity Hospital — Madrid

Identifiers

NCT: NCT07348341 · PHI-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗