Эффективность и безопасность сосудистого окклюзионного устройства LOBO™ для эмболизации легочных артериовенозных мальформаций (PAVM)
Эффективность и безопасность сосудистого окклюзионного устройства LOBO™ для эмболизации легочных артериовенозных мальформаций (ПАВМ)
The goal of this clinical trial is to evaluate both the technical success and efficacy of using the LOBO™ device in patients undergoing embolization of Pulmonary Arteriovenous Malformations (PAVM). The main question[s] it aims to answer [is/are]:
- What is the technical success rate, the number of LOBO™ devices needed for occlusion, and time to occlusion for each feeding artery during PAVM embolization using the LOBO™ device?
- What is the short-term occlusion rate of the LOBO™ device for PAVM embolization (6 months post-embolization)?
- What are the medium- and long-term occlusion rate of the LOBO™ device in PAVMs (12 months and 36 months post embolization)?
Researchers will compare the percentage of LOBO™ embolized PAVMs that develop recanalization at 6, 12, and 36- month intervals compared to percentage of conventionally embolized PAVMs that develop recanalization at the same intervals.
Participants will undergo the embolization procedure and be followed for 36 months after the procedure. There will be a total of 4 study visits:
- Treatment visit
- 6-Month Follow-up visit
- 12-Month Follow-up visit
- 36-Month Follow-up visit
At each clinical follow-up visit participants will undergo imaging with a computed tomography angiography (CTA) of the chest.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This is a prospective, interventional, single-center investigation involving the enrollment of 30 participants with PAVMs with feeding arteries ≥2 mm in diameter. Per standard of care and current clinical practice at UNC, all patients are first evaluated at the UNC Hereditary Hemorrhagic Telangiectasia (HHT) clinic which is run by the UNC Hematology Division. Based on clinical symptoms and signs (shortness of breath, hypoxia, positive bubble study, history of stroke or transient ischemic attack), and/or imaging findings (i.e., feeding artery size) on chest computed tomography angiography (CTA), patients are referred to interventional radiology for consultation for PAVM embolization. At this time, patients will be approached for enrollment in this study. This study aims to assess the technical success and rates of recanalization of PAVMs embolized using the LOBO™ device.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
North Carolina
-
Chapel Hill, North Carolina, Соединенные Штаты, 27599
- University of North Carolina at Chapel Hill
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- At least 1 PAVM with a feeding artery ≥2 mm in diameter and a feeding artery amenable to the use of LOBO™ device (i.e. feeding artery length of ≥1 cm). Given the length of embolic devices including LOBO™, the proximal vessel length to the PAVM sac must be of sufficient size for embolization to be feasible. If patients have at least 1 PAVM where the feeding artery length is ≥1 cm, they are eligible for enrollment.
- Patients with multiple PAVMs meeting eligibility criteria may be enrolled with the intent of embolizing multiple different PAVMs with the LOBO™ device in the same embolization session or in separate sessions.
- Estimated Glomerular Filtration Rate >30 ml/min
- Per standard of care (SOC), all pregnant women to be enrolled must be in their 2nd or 3rd trimesters
Exclusion Criteria:
- Confounding bleeding disorders other than HHT
- Life-threatening iodinated contrast allergy not amenable to prophylactic therapy with steroids
- Underlying coagulopathy
- Patients on anti-platelets or anti-coagulation medications
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: PAVM Embolization
This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device. |
This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device. Participants will undergo PAVM embolization with the LOBO™ device per standard of care. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of Technical Success
Временное ограничение: At treatment until stasis is achieved. Approximately 1 - 2 hours.
|
Technical success will be defined as the successful deployment of the LOBO™ device in the intended vessel and complete occlusion of the vessel. Successful deployment will be defined as 1) no technical malfunctions in the LOBO™ deployment system that leads to an inability to deploy the device and 2) deployment of the device into the intended vessel and not into surrounding vessels. Complete occlusion will be defined as complete cessation of blood flow through the embolized vessel based on intraprocedural angiography. |
At treatment until stasis is achieved. Approximately 1 - 2 hours.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean Number of LOBO Plugs
Временное ограничение: At treatment until stasis is achieved. Approx. 1 - 2 hours.
|
Descriptive statistics for the number of LOBO™ devices needed for technical success will be reported. |
At treatment until stasis is achieved. Approx. 1 - 2 hours.
|
|
Mean Time to Complete Occlusion
Временное ограничение: At treatment until stasis is achieved. Approx. 1 - 2 hours.
|
Descriptive statistics for the time to completion will be reported. |
At treatment until stasis is achieved. Approx. 1 - 2 hours.
|
|
Short-term Occlusion Rate
Временное ограничение: 6 months post-embolization
|
Recanalization will be defined as contrast visualization through the plug or the aneurysmal sac on follow-up CTA's. Interpretation of these images will be done by standard clinical radiologists and not research personnel. The reading radiologist's interpretation will be used to determine if recanalization has occurred. |
6 months post-embolization
|
|
Medium- and Long-term Occlusion Rates
Временное ограничение: 12 months and 36 months post-embolization
|
Recanalization will be defined as contrast visualization through the plug or the aneurysmal sac on follow-up CTA's. Interpretation of these images will be done by standard clinical radiologists and not research personnel. The reading radiologist's interpretation will be used to determine if recanalization has occurred. |
12 months and 36 months post-embolization
|
|
Recanalization Rates by Modality (LOBO vs conventional)
Временное ограничение: 6, 12, and 36-months post-embolization
|
Proportion of LOBO™ embolized PAVMs that develop recanalization at 6, 12, and 36- month intervals compared to proportion of conventionally embolized PAVMs (those embolized with coils, Amplatzer, MVPs) that develop recanalization at the same intervals. The retrospective comparator group will consist of patients who have undergone conventional embolization at UNC in a separate trial. |
6, 12, and 36-months post-embolization
|
Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Nima Kokabi, MD, University of North Carolina, Chapel Hill
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
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
Другие идентификационные номера исследования
- 24-2233
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Сроки обмена IPD
Beginning 9 and continuing for 36 months following publication.
Критерии совместного доступа к IPD
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
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. .