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Идёт набор NCT06099015

Cera™ Vascular Plug System Post-Market Clinical Follow-Up

— Наблюдательное Aneurysm Endoleak Pulmonary Arteriovenous Malformation Portal Hypertension

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: Cera™ Vascular Plug System.
Кому может быть актуально
Состояния в реестре: Aneurysm, Endoleak, Pulmonary Arteriovenous Malformation, Portal Hypertension. Базовые параметры: 18 лет — 85 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
Германия, Италия, Turkey (Türkiye)
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

Cera™ Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study

Обзор

The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: * confirm the performance * confirm the safety * identify previously unknown side-effects * monitor the identified side-effects (related to the procedures or to the medical devices) * identify and analyse emergent risks

Подробное описание

Lifetech Cera™ Vascular Plug System is indicated for arterial and venous embolization in the peripheral vasculature. This study, planned under the MDR requirements, aims to confirm the safety and performance of the Lifetech Cera™ Vascular Plug System, identify previously unknown side-effects, monitor the identified side-effects (related to the procedures or to the medical devices), identify and analyse emergent risks. The Study intends to enroll 132 subjects. The estimated enrollment period is 1 year, and the expected duration of each subject's participation is 1 year (i.e., the follow-up period). Final report shall be completed in 2026.

Вмешательства

  • Устройство Cera™ Vascular Plug System
    The Cera™ Vascular Plug System is composed of Cera™ Vascular Plug and its accessory Introducer Kit. The Cera™ Vascular Plug is a self-expandable, cylindrical Ni-Ti wire mesh device.

Первичные конечные точки

  • Technical success [Срок оценки: at procedure]
Вторичные конечные точки (6)
  • Incidence of clinically relevant recanalization [Срок оценки: at 3 months, 6 months, and 12 months post-procedure]
  • Incidence of clinically relevant migration [Срок оценки: at 3 months, 6 months, and 12 months post-procedure]
  • Incidence of device and/or procedure-related Adverse Events (AEs) [Срок оценки: from attempted procedure to 12 months post-procedure]
  • Incidence of device and/or procedure-related Serious Adverse Events (SAEs) [Срок оценки: from attempted procedure to 12 months post-procedure]
  • Incidence of device deficiencies [Срок оценки: from attempted procedure to 12 months post-procedure]
  • Time to occlusion [Срок оценки: at procedure]

Критерии участия

Критерии включения

  • Aged 18 to 85;
  • Life expectancy > 1 year;
  • Require arterial or venous embolization in the peripheral vasculature;
  • Target embolization site(s) allow for safe insertion of the delivery catheter;
  • Voluntarily sign and date the Informed Consent Form (ICF) prior to any study-related activities commencement;
  • Willing and able to comply with protocol requirements, including all study visits and procedures.
  • Patients for whom the doctor has decided to use the Cera Vascular Plug System, regardless of the study.

Критерии исключения

  • The subject is pregnant or plan to be pregnant or breast feeding;
  • The subject has a known allergy or hypersensitivity to any of the device materials including: nickel, stainless steel, polytetrafluoroethylene and titanium nitride;
  • The subject has a known allergy or hypersensitivity to contrast agent;
  • The subject has uncorrectable coagulopathy;
  • The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, during and/or after treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints
  • The subject has an unresolved systemic infection;
  • Subject who cannot tolerate general or local anesthesia;
  • The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder;
  • The subject is participating in other drug or medical device clinical trials;
  • Any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 4 центра
  • ASST Grande Ospedale Metropolitano Niguarda — Milan
  • IRCCS Ospedale San Raffaele — Milan
  • A.O.U. Città della Salute e Della Scienza di Torino — Turin
  • Ospedale di Circolo — Varese
Turkey (Türkiye) · 4 центра
  • Adana City Hospital — Adana
  • Ankara University Hospital — Ankara
  • Bilkent City Hospital — Ankara
  • Bilkent City Hospital — Ankara
Германия · 1 центр
  • Klinikum Bad Hersfeld GmbH — Bad Hersfeld

Идентификаторы

NCT: NCT06099015 · LT-TS-22CE-04-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗