Аспирационная тромбэктомия с использованием системы Symphony или Prodigy (CLEAR-IT)
Долгосрочное клиническое исследование аспирационной тромбэктомии с использованием систем Symphony или ProdIgy - CLEAR-IT
The study is designed to evaluate the short-term and long-term clinical performance and safety of the Symphony and Prodigy thrombectomy systems used in endovascular procedures across the peripheral or pulmonary vasculature.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Sylvie Akiel-Fu, MPH
- Номер телефона: 917-375-4735
- Электронная почта: safu@imperativecare.com
Места учебы
-
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Alabama
-
Huntsville, Alabama, Соединенные Штаты, 35801
- Рекрутинг
- Huntsville Hospital
-
-
Florida
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Clearwater, Florida, Соединенные Штаты, 33756
- Рекрутинг
- BayCare Health System- Morton Plant Hospital
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Jacksonville, Florida, Соединенные Штаты, 32216
- Рекрутинг
- HCA Florida Memorial Hospital
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Tampa, Florida, Соединенные Штаты, 33607
- Рекрутинг
- BayCare Health System - St. Joseph Hospital
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Illinois
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Naperville, Illinois, Соединенные Штаты, 60540
- Рекрутинг
- Midwest Cardiovascular Institute
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Indiana
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Munster, Indiana, Соединенные Штаты, 46321
- Рекрутинг
- Profound Research
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Michigan
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Detroit, Michigan, Соединенные Штаты, 48202
- Рекрутинг
- Henry Ford Hospital
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New York
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Buffalo, New York, Соединенные Штаты, 14203
- Рекрутинг
- University At Buffalo
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New York, New York, Соединенные Штаты, 10029
- Рекрутинг
- Mount Sinai Hospital
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North Carolina
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Raleigh, North Carolina, Соединенные Штаты, 27607
- Рекрутинг
- NC Heart and Vascular Research
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45242
- Рекрутинг
- Mercy Health
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Texas
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Fort Worth, Texas, Соединенные Штаты, 761104
- Рекрутинг
- Medical City Fort Worth Hospital
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Virginia
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Norfolk, Virginia, Соединенные Штаты, 23502
- Рекрутинг
- Sentara Norfolk General Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
The study will enroll subjects aged 18 years and older who are undergoing endovascular procedures in the peripheral or pulmonary vasculature systems where, in the opinion of the treating physician, Imperative Care devices are appropriate for use within their cleared indications. All subjects must meet the general eligibility criteria and provide written informed consent prior to any study-specific data collection.
Описание
Inclusion Criteria:
- Subject is ≥ 18 years of age
- Subject is willing and able to comply with the follow-up schedule specified in this protocol
- Subject is willing and able to provide written informed consent prior to any study-related data collection
- Subject has a planned procedure, involving the use of Imperative Care vascular devices within their intended use
Exclusion Criteria:
- Subjects with any contraindications per the applicable Instructions for Use
- Subject with life expectancy of less than 1 year
- In the opinion of the Investigator, the patient is not a suitable candidate for intervention with Imperative Care devices
- Subject who may be unable to complete study follow-up
- Peripheral Venous Cohort ONLY: Presence of thrombus extending more than 2 cm into the IVC on imaging
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Peripheral Arterial
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature |
Removal of thrombus/emboli from blood vessels in the peripheral vasculature |
|
Peripheral Venous
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral venous vasculature |
Removal of thrombus/emboli from blood vessels in the peripheral vasculature Removal of thrombus/emboli from the pulmonary vasculature |
|
Pulmonary Embolism
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the pulmonary vasculature |
Removal of thrombus/emboli from blood vessels in the peripheral vasculature Removal of thrombus/emboli from the pulmonary vasculature |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Peripheral Arterial Cohort
Временное ограничение: 30 days
|
Freedom from major (above-ankle) unanticipated amputation of the index limb |
30 days
|
|
Peripheral Venous Cohort
Временное ограничение: 30 days
|
Treated limb improvement at 30 days, defined as no unplanned intervention for breakthrough re-thrombosis and improvement in Villalta score relative to baseline. |
30 days
|
|
Pulmonary Embolism (PE) Cohort
Временное ограничение: 30 Days
|
Normal right ventricular function at 30 days follow-up, defined as tricuspid annular plane systolic excursion (TAPSE) >1.7cm , measured on transthoracic echocardiography (TTE) and independently adjudicated. |
30 Days
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Peripheral Arterial Cohort
Временное ограничение: 90 Days
|
Freedom from major (above-ankle) amputation of the index limb |
90 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 180 Days
|
Freedom from major (above-ankle) amputation of the index limb |
180 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 30 Days
|
Major adverse cardiovascular events (MACE) rate |
30 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 90 Days
|
Major adverse cardiovascular events (MACE) rate |
90 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 180 Days
|
Major adverse cardiovascular events (MACE) rate |
180 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 30 Days
|
Target vessel patency assessed using change in ankle-brachial index |
30 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 90 Days
|
Target vessel patency assessed using change in ankle-brachial index |
90 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 180 Days
|
Target vessel patency assessed using change in ankle-brachial index |
180 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 30 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
30 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 90 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
90 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 180 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
180 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 30 Days
|
Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management |
30 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 90 Days
|
Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management |
90 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 180 Days
|
Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management |
180 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 90 Days
|
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) |
90 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 180 Days
|
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) |
180 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 30 Days
|
All-cause mortality |
30 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 90 Days
|
All-cause mortality |
90 Days
|
|
Peripheral Arterial Cohort
Временное ограничение: 180 Days
|
All-cause mortality |
180 Days
|
|
Peripheral Venous Cohort
Временное ограничение: Intraprocedural
|
Technical success defined as complete or near complete (>75%) reduction in Marder score from baseline to immediately after the use of the device and prior to any use of adjunctive device, as independently adjudicated |
Intraprocedural
|
|
Peripheral Venous Cohort
Временное ограничение: 48 hours
|
Rate of Major Adverse Events (MAEs) as adjudicated by an independent medical monitor and defined as the occurrence of any of the following:
|
48 hours
|
|
Peripheral Venous Cohort
Временное ограничение: 90
|
Treated limb improvement at 90 days, defined as no unplanned intervention for re-thrombosis in patients who are compliant with prescribed medical management and improvement in Villalta score relative to baseline |
90
|
|
Peripheral Venous Cohort
Временное ограничение: 180
|
Treated limb improvement at 180 days, defined as no unplanned intervention for re-thrombosis in patients who are compliant with prescribed medical management and improvement in Villalta score relative to baseline |
180
|
|
Peripheral Venous Cohort
Временное ограничение: 30 Days
|
Proportion of patients demonstrating decrease in Villalta score (A decrease in Villalta score reflects an improvement per the following scale: 0-4 - no disease; 5-9: mild disease; 10-14: moderate disease; 15 or > : severe disease) |
30 Days
|
|
Peripheral Venous Cohort
Временное ограничение: 90 Days
|
Proportion of patients demonstrating decrease in Villalta score |
90 Days
|
|
Peripheral Venous Cohort
Временное ограничение: 180 Days
|
Proportion of patients demonstrating decrease in Villalta score |
180 Days
|
|
Peripheral Venous Cohort
Временное ограничение: 30 Days
|
Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure. |
30 Days
|
|
Peripheral Venous Cohort
Временное ограничение: 60 Days
|
Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure. |
60 Days
|
|
Peripheral Venous Cohort
Временное ограничение: 180 Days
|
Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure. |
180 Days
|
|
Peripheral Venous Cohort
Временное ограничение: 180 Days
|
Quality of life and symptom severity assessment using the Venous Insufficiency Epidemiological and Economic Study (VEINES -QOL); higher scores indicate better quality of life/fewer symptoms |
180 Days
|
|
Peripheral Venous Cohort
Временное ограничение: 30 Days
|
All-cause mortality |
30 Days
|
|
Peripheral Venous Cohort
Временное ограничение: 90 Days
|
All-cause mortality |
90 Days
|
|
Peripheral Venous Cohort
Временное ограничение: 180 Days
|
All-cause mortality |
180 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: Intraprocedural
|
Change in pulmonary artery pressure |
Intraprocedural
|
|
Pulmonary Embolism Cohort
Временное ограничение: 48 hours
|
Normal tricuspid annular plane systolic excursion (TAPSE) - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Временное ограничение: 48 hours
|
Right ventricle fractional area change (FAC) on TTE pre-procedure, 48 hours - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Временное ограничение: 30 Days
|
Right ventricle fractional area change (FAC) on TTE pre-procedure, 30 days - independently adjudicated |
30 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 48 hours
|
Tricuspid annular peak systolic velocity (S') pre-procedure, 48 hours - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Временное ограничение: 30 Days
|
Tricuspid annular peak systolic velocity (S') pre-procedure, 30 days - independently adjudicated |
30 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 48 hours
|
Rate of Major Adverse Events (MAEs) as adjudicated by an independent medical monitor and defined as the occurrence of any of the following:
|
48 hours
|
|
Pulmonary Embolism Cohort
Временное ограничение: 30 days
|
Right ventricle to left ventricle (RV/LV) ratio reduction from baseline |
30 days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 90 Days
|
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class |
90 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 180 Days
|
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class |
180 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 30 Days
|
Pulmonary Embolism recurrence |
30 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 90 Days
|
Pulmonary Embolism recurrence |
90 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 180 Days
|
Pulmonary Embolism recurrence |
180 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 30 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
30 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 90 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
90 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 180 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
180 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 30 Days
|
All-cause mortality |
30 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 90 Days
|
All-cause mortality |
90 Days
|
|
Pulmonary Embolism Cohort
Временное ограничение: 180 Days
|
All-cause mortality |
180 Days
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Steven Abramowitz, MD, Medstar Health Research Institute
- Главный следователь: Maya Serhal, MD, Massachusetts General Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ICI-2025-002
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .