Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations

Официальное название

Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations (PAVM)

Обзор

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.

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.

Вмешательства

• Устройство PAVM Embolization
  This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.
• Устройство PAVM Embolization with a LOBO™ device
  Participants will undergo PAVM embolization with the LOBO™ device per standard of care.

Первичные конечные точки

• Proportion of Technical Success [Срок оценки: At treatment until stasis is achieved. Approximately 1 - 2 hours.]

Вторичные конечные точки (5)

• Mean Number of LOBO Plugs [Срок оценки: At treatment until stasis is achieved. Approx. 1 - 2 hours.]
• Mean Time to Complete Occlusion [Срок оценки: At treatment until stasis is achieved. Approx. 1 - 2 hours.]
• Short-term Occlusion Rate [Срок оценки: 6 months post-embolization]
• Medium- and Long-term Occlusion Rates [Срок оценки: 12 months and 36 months post-embolization]
• Recanalization Rates by Modality (LOBO vs conventional) [Срок оценки: 6, 12, and 36-months post-embolization]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of North Carolina at Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT06735976 · 24-2233

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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