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Идёт набор NCT05145517

A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts

— Наблюдательное Vascular Diseases

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: Open repair.
Кому может быть актуально
Состояния в реестре: Vascular Diseases. 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
Германия
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

FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts

Обзор

The FLOWGRAFT post-market clinical follow-up study is undertaken to show the safety and performance of FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore and FlowLine Bipore Heparin (combined named as Vascular Grafts) in the treatment of arterial diseases, such as dissection, aneurysm, intramural hematoma (IMH), penetrating aortic ulcer (PAU), contained rupture, stenosis in the aorta or peripheral arteries (lower limbs). This includes the use of FlowWeave Bioseal or FlowNit Bioseal for debranching of the head vessels in an alone standing procedure. Furthermore, it includes the use of the FlowLine Bipore and FlowLine Bipore Heparin Grafts as arterious-venous (AV) shunt.

Подробное описание

In this study, patients who receive a Vascular Graft for the treatment of arterial diseases (aneurysm, PAU, IMH, dissection, stenosis) of the aorta or peripheral arteries (lower limbs) or as an AV shunt will be observed. This includes patients in whom the Vascular Grafts are used for debranching or reconstruction of the head vessels. Participating physicians will be asked to provide the observations, that were collected during routine care. Written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient prior to data collection.

The period of data collection will be approximately 60 + 6 months (depending on the date of the last follow-up visit) from the date of intervention for each patient.

Вмешательства

  • Устройство Open repair
    Open repair of the aorta and peripheral arteries

Первичные конечные точки

  • Mortality [Срок оценки: 30-day]
Вторичные конечные точки (10)
  • All-cause mortality [Срок оценки: 30-day, 6-month,12-month, 24-month, 36-month, 60-month]
  • Vascular Graft-related adverse event [Срок оценки: 30-day, 6-month,12-month, 24-month, 36-month, 60-month]
  • Freedom from Vascular Graft -related hemorrhage [Срок оценки: 6-month,12-month, 24-month, 36-month, 60-month]
  • Vascular Graft stenosis > 50% or occlusion [Срок оценки: 6-month,12-month, 24-month, 36-month, 60-month]
  • Vascular Graft primary patency [Срок оценки: 6-month,12-month, 24-month, 36-month, 60-month]
  • Vascular Graft secondary patency (after reintervention) [Срок оценки: 6-month,12-month, 24-month, 36-month, 60-month]
  • Pseudoaneurysm at the sutures or in the Vascular Graft [Срок оценки: 6-month,12-month, 24-month, 36-month, 60-month]
  • Vascular Graft infection [Срок оценки: 6-month,12-month, 24-month, 36-month, 60-month]
  • New sepsis [Срок оценки: 6-month,12-month, 24-month, 36-month, 60-month]
  • New stroke [Срок оценки: 6-month,12-month, 24-month, 36-month, 60-month]

Критерии участия

Критерии включения

  • Patient ≥ 18 years at time of written informed consent
  • Patient was selected for treatment with a commercially available Vascular Graft of JOTEC
  • Patient satisfies at least one of the following categories:
  • Acute (14 days) / subacute (15 - 90 days) dissection with double lumina in the aorta or peripheral artery / arteries (lower limb)
  • Chronic (>90 days) dissection with double lumina in the aorta or peripheral artery / arteries (lower limb)
  • Aneurysm in the aorta or peripheral artery / arteries (lower limb)
  • IMH in the aorta or peripheral artery / arteries (lower limb)
  • PAU in the aorta or peripheral artery / arteries (lower limb)
  • Contained rupture in the aorta or peripheral artery / arteries (lower limb)
  • Stenosis in the aorta or peripheral artery / arteries (lower limb)
  • Debranching of head vessels
  • AV shunt
  • Patient is willing and able to comply with all clinical study procedures and study visits.
  • Patient has given written informed consent to participate in the study.

Критерии исключения

  • Patient has any other medical, social, or psychological problem that in the opinion of the investigator preclude them from receiving this treatment, procedures, and evaluations pre- and post-procedure.
  • Patient is scheduled for reconstruction of the tibial artery

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Universitätsklinikum Münster — Münster

Идентификаторы

NCT: NCT05145517 · FLOWGRAFT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗