Меню
Идёт набор NCT05674630

Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

Фаза IV С лечением Chronic Coronary Syndrome

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: Magic Touch drug eluting balloon based strategy, Drug-eluting stent-based strategy.
Кому может быть актуально
Состояния в реестре: Chronic Coronary Syndrome. 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons

Обзор

The goal of this clinical trial is to compare the use of a specific drug eluting balloon (Magic Touch, Concept Medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions. Participants with chronic coronary disease and long coronary stenosis will be randomly assign to be treated either with Magic Touch balloon or drug eluting stent.

Подробное описание

Patients at coronary angiography who are deemed suitable for PCI are assessed for eligibility. Patients fulfilling all inclusion and no exclusion criteria can be consented for trial participation. After successful lesion preparation, defined as residual stenosis less than 30%, TIMI flow 3 and no major (type C) dissection of target lesion, consented patients will be randomized in a 1:1 ratio to a drug eluting balloon(DEB)-based or standard drug eluting stent(DES)-based strategy and further randomized in a 1:1 fashion, stratified based on DEB vs DES, to undergo invasive follow-up at 6 (±30 days) or 12 (±30 days) months.

Вмешательства

  • Устройство Magic Touch drug eluting balloon based strategy
    Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the experimental arm will receive treatment with drug eluting balloon (Magic Touch®) followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.
  • Устройство Drug-eluting stent-based strategy
    Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the control arm will receive treatment with drug-eluting stent followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.

Первичные конечные точки

  • Absolute change of FFR values (ΔFFR) [Срок оценки: At 6(±30days) or 12(±30 days) months after the index PCI]
Вторичные конечные точки (12)
  • QCA parameter (minimal lumen diameter, MLD, mm) before and after the intervention and at follow-up angiography [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]
  • QCA parameter (maximal diameter stenosis, MaxS, percent) before and after the intervention and at follow-up angiography [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]
  • QCA parameter (reference vessel diameter, RVD, mm) before and after the intervention and at follow-up angiography [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]
  • QCA parameter (lesion length, LL, mm) before and after the intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]
  • QFR parameters before and after intervention and at follow-up angiography [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]
  • FFR parameters before and after intervention and at follow-up angiography [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]
  • Minimal lumen diameter (MLD, mm) [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]
  • Minimal luminal area (MLA, mm^2) [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]
  • Maximal diameter stenosis (MaxS, percent) [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]
  • Lumen volume (LV, mm^3) [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]
  • Vessel volume (VV, mm^3) [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]
  • Plaque burden (VV-LV) [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI]

Критерии участия

Критерии включения

  • Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCI
  • At least one significant de-novo coronary lesion (defined as diameter stenosis > 50% on angiography, with flow limiting features, confirmed with FFR ≤0.80 or iFR ≤0.89 and intended implantation of a long (≥30 mm) DES based on IVUS findings
  • Written informed consent

Критерии исключения

  • Patients referred to the index procedure for an acute coronary syndrome
  • Target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery
  • Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis treatment
  • Spontaneous coronary artery dissection (SCAD)
  • Contraindications to adenosine administration (e.g. moderate to severe asthma or chronic obstructive pulmonary disease, heart rate <50 beats/min and systolic blood pressure <90 mmHg)
  • Known pregnancy or breast-feeding patients
  • Life expectancy <1 year due to other severe non-cardiac disease
  • Legally incompetent to provide informed consent
  • Participation in another clinical study with an investigational product

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

Швейцария · 1 центр
  • Marco Valgimigli — Lugano

Идентификаторы

NCT: NCT05674630 · 01_TITAN-DEB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗