Идёт набор NCT06807099

WRAP North America

— Наблюдательное Venous Stenosis Venous Occlusion

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: Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE).
Кому может быть актуально: Состояния в реестре: Venous Stenosis, Venous Occlusion. 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: США, Канада
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

Prospective, Multicenter, Observational Study to Evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion Within the Dialysis Outflow Circuit (WRAP North America)

Обзор

The goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population. Participants treated with the WRAPSODY CIE device in accordance with the device instructions for use will be followed in accordance with standard of care up to 3-years post-procedure.

Подробное описание

Prospective, multicenter, observational study to evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit (WRAP North America)

Вмешательства

Устройство Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
Target Lesion treated with WRAPSODY CIE

Первичные конечные точки

Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint) [Срок оценки: 6 months]
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint) [Срок оценки: 30 days]

Вторичные конечные точки (4)

Proportion of subjects with Target Lesion Primary Patency [Срок оценки: 12, 24 and 36 months]
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP) [Срок оценки: 6, 12, 24 and 36 months]
Proportion of subjects with Access Circuit Primary Patency (ACPP) [Срок оценки: 6, 12, 24 and 36 months]
Rates of procedure- and device-related adverse events [Срок оценки: Index procedure, 30 days, 6, 12, 24 and 36 months]

Критерии участия

Критерии включения

Subject provides written informed consent for study participation.
Subject is male or female, with an age ≥ 18 years at date of enrollment.
Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 36 months.
Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon.
The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session.
Subject has stenosis or occlusion within the dialysis outflow circuit and is treated with WRAPSODY CIE in accordance with device instructions for use.

Критерии исключения

Subject has a planned surgical revision of access site.
Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
Subject has an uncorrectable coagulation disorder.
Known hypersensitivity to nickel or titanium.
Subject's hemodialysis access is anticipated to be abandoned within 6 months.
Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure.
Full expansion of a PTA balloon cannot be achieved during predilatation.
Device would be placed in the Superior Vena Cava
Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.

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

Здоровые добровольцы: Нет