Ticin Pilot Study: Sirolimus-Eluting Balloon for Stabilization and Regression of Non-Obstructive Coronary Plaques.

Официальное название

TITAN-PARADISE Pilot: TicIn for the Treatment of Coronary Lesions - Plaque Regression and Stabilization With Sirolimus Elution (Pilot Study)

Обзор

The goal of this pilot clinical trial is to evaluate the use of the Selution SLR sirolimus-eluting balloon, in addition to guideline-directed medical therapy (GDMT), for the preventive treatment of non-flow-limiting vulnerable coronary lesions, compared to GDMT alone, in adult patients with multivessel coronary artery disease and a recent acute coronary syndrome (within 90 days). The main research question is: Does the use of the Selution SLR sirolimus-eluting balloon in combination with GDMT reduce the progression and vulnerability of non-flow-limiting vulnerable coronary plaques? Participants will undergo * PCI procedure with baseline IVUS-NIRS assessment * Follow-up coronary angiography at 6 months with IVUS-NIRS assessment * Clinical follow-up at 3, 6, and 24 months after study enrollment

Вмешательства

• Устройство Sirolimus drug eluting ballooon therapy
  Non-flow limiting vulnerable coronary plaques are treated using sirolimus drug eluting balloon therapy additional to guidelines directed medical therapy.
• Препарат Optimal guidelines-directed medical therapies (GDMT)
  Optimal guidelines-directed medical therapies (GDMT) to reduce plaque burden and vulnerability for non-flow limiting vulnerable plaques

Первичные конечные точки

• Absolute change in the IVUS-NIRS derived lipid core burden index (MAXLCBI4mm) between baseline and 6-months follow-up. [Срок оценки: Between baseline and 6-months follow-up.]

Вторичные конечные точки (12)

• QCA parameter (minimal lumen diameter, MLD, mm) before and after intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.]
• QCA parameter (maximal diameter stenosis, MaxS,%) before and after intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.]
• QCA parameter (reference vessel diameter, RVD, mm) before and after intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.]
• QCA parameter (lesion lenght, LL, mm) before and after intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.]
• QFR parameters before and after the intervention and at follow-up angiography [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.]
• IVUS parameter (minimal lumen diameter, MLD, mm) before the intervention, immediately after the intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.]
• IVUS parameter (minimal lumen area, MLA, mm2) before the intervention, immediately after the intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.]
• IVUS parameter (maximal diameter stenosis, MaxS,%) before the intervention, immediately after the intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.]
• IVUS parameter (lumen volume, LV, mm3) before the intervention, immediately after the intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.]
• IVUS parameter (vessel volume, VV, mm3) before the intervention, immediately after the intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.]
• IVUS parameter (plaque burden, VV-LV) before the intervention, immediately after the intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.]
• IVUS parameter (late lumen loss, LLL) before the intervention, immediately after the intervention and at follow-up angiography. [Срок оценки: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.]

Критерии участия

Критерии включения

Potential subjects must fulfill all following inclusion criteria:

• Multivessel coronary artery disease with ACS within 90 days prior to inclusion and successful interventional treatment of the culprit lesion
• Presence of ≥ 2 de novo non-culprit lesion without hemodynamic relevance in two different coronary vessels (demonstrated either by wire-based or angiography-based coronary physiology) and with MaxLCBI4mm ≥ 325 at baseline IVUS-NIRS
• Age ≥ 18 years
• Written informed consent

Критерии исключения

Patients are not eligible if any of the following applies:

• Non culprit lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery;
• Non-culprit lesion in a previously stented segment (i.e. within 15 mm from the previously implanted stent);
• Non-culprit lesion involving small vessel (<3.0 mm) deemed not suitable to PCI,
• Non-culprit lesion located in a bypass graft or in a grafted vessel;
• Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis treatment;
• Known pregnancy r breast-feeding patients;
• Life expectancy <2 year due to other severe non-cardiac disease;
• Legally incompetent to provide informed consent;
• Partecipation 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

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Istituto Cardiocentro Ticino - EOC — Lugano

Идентификаторы

NCT: NCT06928883 · TITAN-PARADISE Pilot

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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