Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations (PAVM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of Technical Success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PAVM Embolization
This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.
干预措施: PAVM Embolization (Device)
PAVM Embolization
This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.
干预措施: PAVM Embolization with a LOBO™ device (Device)
结局指标
主要结局
Proportion of Technical Success
时间窗: 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.
次要结局
- Mean Number of LOBO Plugs(At treatment until stasis is achieved. Approx. 1 - 2 hours.)
- Mean Time to Complete Occlusion(At treatment until stasis is achieved. Approx. 1 - 2 hours.)
- Short-term Occlusion Rate(6 months post-embolization)
- Medium- and Long-term Occlusion Rates(12 months and 36 months post-embolization)
- Recanalization Rates by Modality (LOBO vs conventional)(6, 12, and 36-months post-embolization)