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Идёт набор NCT07000045

Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment

Без фазы С лечением Coronary Artery Disease Coronary Calcification

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: Intravascular lithotripsy, Rotational atherectomy.
Кому может быть актуально
Состояния в реестре: Coronary Artery Disease, Coronary Calcification. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs. Intravascular Lithotripsy Alone: A Prospective, Randomized Trial (NODULE-SHOCK)

Обзор

The NODULE-SHOCK trial is a prospective, investigator-initiated, single-center, randomized controlled trial designed to compare the efficacy of intravascular lithotripsy (IVL) with or without rotational atherectomy (RA) in patients with coronary calcified nodules (Cohort A), and operator-determined vs maximum IVL pulses in patients with non-nodular severe coronary calcium (Cohort B).

Подробное описание

The trial consists of two cohorts:

* Patients with calcified nodules (CN) (Cohort A) * Patients with non-nodular severe coronary calcium (Cohort B)

Randomization will occur as follows:

* Rotational atherectomy followed by intravascular lithotripsy (IVL) or IVL alone for lesion preparation prior to stenting (Cohort A). * Operator-determined or maximum IVL pulses prior to stenting. (Cohort B)

The trial is designed to compare two calcium modification strategies in each cohort with regard to the primary endpoints of post-procedural minimum stent area assessed by optical coherence tomography at the CN site (Cohort A) and at the site of maximum calcification (Cohort B).

Вмешательства

  • Устройство Intravascular lithotripsy
    Intravascular lithotripsy device used for calcium modification in coronary lesions, using either operator-determined or maximum pulsed numbers for lesion preparation prior to stenting.
  • Устройство Rotational atherectomy
    Rotational atherectomy device used to debulk calcified nodules before IVL and stent implantation.

Первичные конечные точки

  • Minimum stent area (MSA) [Срок оценки: Immediately after Index procedure]
Вторичные конечные точки (11)
  • Number of Calcium fractures [Срок оценки: Immediately after Index procedure]
  • Target vessel failure (TVF) [Срок оценки: during hospitalization, approximately 1-2 days, 30 days, and 12 months]
  • Stent thrombosis [Срок оценки: 12 months]
  • Device success [Срок оценки: Immediately after Index procedure]
  • Angiographic success [Срок оценки: Immediately after Index procedure]
  • Procedural success [Срок оценки: Immediately after Index procedure]
  • Bailout or adjunctive calcium modification [Срок оценки: Intraoperatively during Index procedure]
  • Pre- and post-dilatation ballon size [Срок оценки: Immediately before and after Index procedure]
  • Pre- and post-dilatation inflation pressure [Срок оценки: Immediately before and after Index procedure]
  • Total number of IVL pulses delivered to the lesion during treatment [Срок оценки: Intraoperatively during Index procedure]
  • Lesion length of IVL pulses delivered [Срок оценки: Intraoperatively during Index procedure]

Критерии участия

Критерии включения

  • Age ≥18 years who signed written informed consent
  • Presence of a clinical indication for coronary intervention
  • Patients undergoing PCI for a de novo calcified lesion with planned drug-eluting stent (DES) implantation
  • Native coronary artery with significant stenosis defined as:
  • ≥70% and <100% stenosis on angiography, or
  • 50-70% stenosis with evidence of ischemia (positive stress test, FFR ≤ 0.8, or OCT minimal lumen area (MLA) ≤ 4.0 mm2)
  • Reference vessel diameter: ≥2.5 mm to ≤ 4.0 mm
  • Lesion length: ≥5mm
  • Moderate to severe calcification of the target lesion confirmed by angiography
  • Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 at baseline

Критерии исключения

  • Cardiogenic shock at the time of procedure
  • Primary PCI for ST-segment elevation myocardial infarction (STEMI)
  • Pregnant, nursing, or childbearing potential without adequate contraception
  • Known allergy or contraindication to DAPT (aspirin, clopidogrel, prasugrel, ticagrelor)
  • Planned surgery within 6 months unless DAPT can be maintained
  • Life expectancy <12 months due to a serious medical illness (e.g., advanced cancer, end-stage heart failure)
  • Severe kidney dysfunction (CrCl <30 mL/min) without dialysis
  • Concurrent participation in another investigational study
  • Referral for coronary artery bypass grafting (CABG) after a heart team discussion
  • Angiographic evidence of thrombus at the target lesion
  • Angiographic evidence of significant dissection at the treatment site prior to intervention
  • Lesion with a previously placed stent within 10mm (visual estimate)
  • Last remaining vessel with severely compromised left ventricular function (LVEF <30%)
  • Target lesion within a saphenous vein graft (SVG)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Mount Sinai Hospital — New York

Идентификаторы

NCT: NCT07000045 · STUDY-25-00266 · ISR20250319

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗