Набор скоро начнётся NCT07338890

Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease

— Наблюдательное Superficial Femoral Artery Stenosis Iliac Artery Stenosis Popliteal Artery Stenosis

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: S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL ™ Nitinol Stent System, S.M.A.R.T.™ Flex Vascular Stent System.
Кому может быть актуально: Состояния в реестре: Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Popliteal Artery Stenosis. 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: Испания
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

Post-Market Clinical Follow-Up Study of the S.M.A.R.T.™ Nitinol Stent System, S.M.A.R.T.™ CONTROL™ Nitinol Stent System and S.M.A.R.T. ™ Flex Vascular Stent System in the Treatment of Iliac and Femoropopliteal Artery Disease (REAL-SMART)

Обзор

The purpose of this study is to evaluate long-term safety and performance per the intended use of the S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL™ Nitinol Stent System (SMART CONTROL) and S.M.A.R.T.™ Flex Vascular Stent System (SMART Flex) in the treatment of iliac and femoropopliteal artery disease.

Подробное описание

The REAL-SMART study is a multi-center, non-randomized, observational analysis of retrospective data collected on all subjects treated with SMART 120/150, SMART CONTROL or SMART Flex. The purpose of this study is to evaluate long-term safety and performance per the intended use of the three (3) study devices. Each device constitutes a separate study arm and each arm is further stratified by indication, of which there are two per device. The study is conducted in approximately 20 sites located in approximately three (3) European countries with high volume use of one or more of the study devices. The enrollment and data collection take approximately 6-8 months.

Вмешательства

Устройство S.M.A.R.T.™ Nitinol Stent System (SMART 120/150)
The Cordis S.M.A.R.T.™ Nitinol Stent System is intended to deliver a self-expanding endovascular stent to the peripheral vasculature via a sheathed delivery system. The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T. ™ Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of the superficial femoral artery and proximal popliteal artery.
Устройство S.M.A.R.T.™ CONTROL ™ Nitinol Stent System
The Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System is intended to deliver a self-expanding endovascular stent to the iliac and/or superficial femoral arteries via a sheathed delivery system. The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T. ™ CONTROL™ Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of iliac and/or superficial femoral arteries.
Устройство S.M.A.R.T.™ Flex Vascular Stent System
The Cordis S.M.A.R.T.™ Flex Stent is a single-use device consisting of an endovascular stent and sheath delivery system, intended to deliver a self-expanding endovascular stent to the superficial femoral artery (SFA). The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T.™ Flex Stent is indicated in enabling treatment of patients with symptomatic vascular stenotic and/or occlusive diseases in the superficial femora

Первичные конечные точки

Technical success of SMART 120/150 in patients with obstructive SFA disease [Срок оценки: At the conclusion of the index procedure]
Major amputation in patients treated with SMART 120/150 for obstructive SFA disease [Срок оценки: At 12 months post-index procedure]
Technical success of SMART 120/150 in patients with obstructive PPA disease [Срок оценки: At the conclusion of the index procedure]
Major amputation in patients treated with SMART 120/150 for obstructive PPA disease [Срок оценки: At 12 months post-index procedure]
Technical success of SMART CONTROL in patients with obstructive iliac artery disease [Срок оценки: At the conclusion of the index procedure]
Major amputation in patients with SMART CONTROL for obstructive iliac artery disease [Срок оценки: At 12 months post-index procedure]
Technical success of SMART CONTROL in patients with obstructive SFA disease [Срок оценки: At the conclusion of the index procedure]
Major amputation in patients treated with SMART CONTROL for obstructive SFA disease [Срок оценки: At 12 months post-index procedure]
Technical success of SMART Flex in patients with obstructive SFA disease [Срок оценки: At the conclusion of the index procedure]
Major amputation in patients treated with SMART Flex for obstructive SFA disease [Срок оценки: At 12 months post-index procedure]

Вторичные конечные точки (12)

Patency at 12 months post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease [Срок оценки: At 12 months post-index procedure]
Patency at 12 months post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease [Срок оценки: At 12 months post-index procedure]
Patency at 12 months post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease [Срок оценки: At 12 months post-index procedure]
Patency at 12 months post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease [Срок оценки: At 12 months post-index procedure]
Patency at 12 months post-index procedure in patients treated with SMART Flex for obstructive SFA disease [Срок оценки: At 12 months post-index procedure]
Patency at 12 months post-index procedure in patients treated with SMART Flex for obstructive PPA disease [Срок оценки: At 12 months post-index procedure]
Target lesion restenosis in patients treated with SMART 120/150 for obstructive SFA disease [Срок оценки: At 12 months post-index procedure]
Target lesion restenosis in patients treated with SMART 120/150 for obstructive PPA disease [Срок оценки: At 12 months post-index procedure]
Target lesion restenosis in patients treated with SMART CONTROL for obstructive iliac artery disease [Срок оценки: At 12 months post-index procedure]
Target lesion restenosis in patients treated with SMART CONTROL for obstructive SFA disease [Срок оценки: At 12 months post-index procedure]
Target lesion restenosis in patients treated with SMART Flex for obstructive SFA disease [Срок оценки: At 12 months post-index procedure]
Target lesion restenosis in patients treated with SMART Flex for obstructive PPA disease [Срок оценки: At 12 months post-index procedure]

Критерии участия

Inclusion Criteria: For data mining purposes, the following criteria will apply in determining which subjects to include in the study:

Subjects treated with SMART 120/150, SMART CONTROL or SMART Flex according to the respective Instructions for Use for treatment in the iliac, superficial femoral and/or proximal popliteal arteries.
If an EC-approved informed consent waiver is not obtained, then documented informed consent from the subject or legal representative granting permission to share the subject's clinical data It is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment/procedure or until time of death, whichever came first.

It is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment/procedure or until time of death, whichever came first. Subjects not included because follow-up information is unavailable will be documented, wherever possible, with respect to demographics and presenting disease state to determine whether they are similar to subjects with follow-up that are enrolled.

Exclusion Criteria: For data mining purposes, the following criteria will apply in determining which subjects to exclude in the study: