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Идёт набор NCT07348341

Coronary Laser Atherectomy Registry From an International Taskforce

— Наблюдательное Stable Coronary Artery Disease Acute Coronary Syndromes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Excimer Laser Coronary Atherectomy (ELCA).
Кому может быть актуально
Состояния в реестре: Stable Coronary Artery Disease, Acute Coronary Syndromes. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Procedural success during index PCI [Срок оценки: During Procedure]
  • Freedom from in hospital Major Adverse Cardiovascular Events [Срок оценки: Periprocedural]
Вторичные конечные точки (12)
  • Composite endpoint of one of events reported [Срок оценки: 30 days and 1 year]
  • Success of revascularization: Freedom from Target lesion failure (TLF) events and ICI assessed stent optimization [Срок оценки: 30 days and 1 year]
  • Procedural Characteristic- Cost [Срок оценки: During procedure]
  • Procedural Characteristic- Device success based on maximum fluence [Срок оценки: During procedure]
  • Procedural Characteristic- Fluoroscopy Time [Срок оценки: During procedure]
  • Procedural Characteristic- Contrast Volume [Срок оценки: During procedure]
  • Procedural characteristic- Device success based on repetition rate [Срок оценки: During procedure]
  • Procedural characteristic- Device success based on pulses number [Срок оценки: During procedure]
  • Procedural characteristic- Device success based on lasing duration [Срок оценки: During Procedure]
  • Procedural characteristic- Device success based on laser trains number [Срок оценки: During procedure]
  • Procedural characteristic- Catheter access [Срок оценки: During Procedure]
  • Requirement of hemodynamic support [Срок оценки: During procedure]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Испания · 1 центр
  • La Paz Universtity Hospital — Madrid

Идентификаторы

NCT: NCT07348341 · PHI-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗