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Идёт набор NCT06663696

CRUZ Tunisia-Multivessel Registry

— Наблюдательное Patient Population With Multivessel Disease

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: Supraflex Cruz Sirolimus-eluting Coronary Stent System.
Кому может быть актуально
Состояния в реестре: Patient Population With Multivessel Disease. Базовые параметры: 18 лет — 99 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
Tunisia
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

Evaluation of the Safety and Clinical Performance of the Biodegradable Polymer-Coated Sirolimus-Eluting Stent in All-Comer Patients With Multivessel Coronary Artery Disease

Обзор

The primary objective of this registry is to evaluate the safety and clinical performance of the biodegradable polymer-coated Supraflex Cruz Sirolimus-eluting Stent (SES) in an unselected, all-comer patient population with multivessel disease. This population represents daily clinical practice and includes patients requiring coronary revascularization with drug-eluting stents (DES).

Подробное описание

This is a prospective, observational, single-arm, multi-center, registry designed to evaluate the safety and clinical performance of the Supraflex Cruz SES in an unselected, all-comer patient population with multivessel disease. The multivessel disease, defined as the presence of two or more vessels that will be exclusively treated with the Supraflex Cruz SES. The registry aims to reflect daily clinical practice including, but not limited to patients with chronic coronary artery disease (CAD) as well as acute coronary syndrome (STEMI and NSTEMI).

All patients will be followed as per routine clinical practice together with either telephonic or clinical follow-up at 30 days, 6 months, and 12 months after the index procedure.

Subgroups are pre-specified for post-hoc exploratory analyses with respect to the primary endpoint of Target Lesion Failure (TLF) at 12 months. The following subgroups are pre-defined according to their presentation at enrolment:

1. Treatment in relation to clinical presentation \[Acute Coronary Syndrome (ACS)\] 2. Treatment in relation to specific lesion subsets \[Left Main, Chronic Total Occlusion\] 3. Patients undergoing atherectomy

Вмешательства

  • Устройство Supraflex Cruz Sirolimus-eluting Coronary Stent System
    Biodegradable polymer-coated, cobalt-chromium sirolimus-eluting coronary stent

Первичные конечные точки

  • Target Lesion Failure (TLF) [Срок оценки: 12 months]
Вторичные конечные точки (6)
  • Target Lesion Failure (TLF) [Срок оценки: 30 days, 6 months]
  • All-cause mortality [Срок оценки: 30 days, 6 months, and 12 months]
  • Any myocardial infarction (MI), includes non-target vessel territory [Срок оценки: 30 days, 6 months, and 12 months]
  • Any revascularization [Срок оценки: 30 days, 6 months, and 12 months]
  • Definite/probable stent thrombosis [Срок оценки: 30 days, 6 months, and 12 months]
  • Target Vessel Failure (TVF) [Срок оценки: 30 days, 6 months, and 12 months]

Критерии участия

Критерии включения

  • Patient must be at least 18 years of age
  • Patients with symptomatic coronary artery multivessel disease requiring the implantation of at least two Supraflex Cruz stents into the coronary vasculature during the index procedure
  • The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a Patient Informed Consent Form
  • The patient is willing and able to co-operate with study procedures and required follow up visits

Критерии исключения

  • Women with known pregnancy or who are lactating
  • High probability of non-adherence to the follow-up requirements (due to social, psychological, or medical reasons)
  • Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
  • Patients has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media

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

Tunisia · 2 центра
  • Sahloul Hospital — Sousse
  • Habib Thameur Hospital — Tunis

Идентификаторы

NCT: NCT06663696 · CRUZ/TUNISIA-MV/01-2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗