Идёт набор NCT05386342

A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters

Без фазы С лечением Thrombus Embolus Occlusion; Vessel

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: TufTex Over-the-Wire Embolectomy Catheter.
Кому может быть актуально: Состояния в реестре: Thrombus, Embolus, Occlusion; Vessel. 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, Швейцария
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

A Post-market Clinical Study to Confirm the Performance and Safety of the LeMaitre TufTex Over-the-Wire (OTW) Embolectomy Catheter on Patients Undergoing Surgical Treatment for the Removal of Arterial Emboli and/or Thrombi

Обзор

A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter

Подробное описание

This clinical investigation is a prospective, single-arm, multicenter, post-market study to proactively collect clinical data on the LeMaitre® TufTex Over-the-Wire (OTW) Embolectomy Catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. The intended purpose of the device in this post market clinical study is identical to the indication of use of the device.

The TufTex OTW post-market study is initiated by the Sponsor and manufacturer of the device, LeMaitre Vascular, Inc.

The investigation will take place in 4 sites, most likely in 3 different countries. A total number of 112 subjects is anticipated to be enrolled, who are intended to undergo surgical treatment for the removal of a emboli and/or thrombi. The anticipated enrollment period is 48 months, and the participation per subject is 1 month. The total study duration is expected to be 56 months (4 months start-up, 48 months of recruitment, 1 month of follow-up, 3 months of closure.

Вмешательства

Устройство TufTex Over-the-Wire Embolectomy Catheter
The OTW Catheter can be used for the removal of emboli and thrombi. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.

Первичные конечные точки

Performance objective is the technical success being <30% residual stenosis [Срок оценки: 1 month post index procedure]
Safety objective is defined as acceptable safety outcomes during the procedure and at follow-up [Срок оценки: 1 month post index procedure]

Вторичные конечные точки (4)

1.Clinical success [Срок оценки: 1 month post index procedure]
2. Revision rate [Срок оценки: 1 month post index procedure]
3. Primary assisted patency [Срок оценки: 1 month post index procedure]
4. Secondary patency [Срок оценки: 1 month post index procedure]

Критерии участия

Критерии включения

Male and female subject, ≥ 18 years of age at time of enrollment.
Subject who is scheduled to undergo surgical treatment for the removal of an emboli or thrombi during an embolectomy and/or thrombectomy procedure, where one of the LeMaitre® Embolectomy Catheter will be used.
Subject signed an Informed Consent for participation.
Subject diagnosed with a embolus/thrombus.
Subjects for whom thrombolytic therapy had failed or was contraindicated.

Критерии исключения

Co-morbidity that in the discretion of the investigator might confound the results.
Subjects who are unable to read or write.
Pregnant or lactating women at time of enrollment
Subjects who are immune compromised

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

Здоровые добровольцы: Нет