Clinical trial NCT06735976: Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations
Official title: Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations (PAVM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Arteriovenous Malformations
Keywords: Embolization
Pulmonary Arteriovenous Malformations
PAVM
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Okami Medical, Inc.
First posted: 2024-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Technical Success
timeFrame: At treatment until stasis is achieved. Approximately 1 - 2 hours.
Secondary outcomes:
measure: Mean Number of LOBO Plugs
timeFrame: At treatment until stasis is achieved. Approx. 1 - 2 hours.
measure: Mean Time to Complete Occlusion
timeFrame: At treatment until stasis is achieved. Approx. 1 - 2 hours.
measure: Short-term Occlusion Rate
timeFrame: 6 months post-embolization
measure: Medium- and Long-term Occlusion Rates
timeFrame: 12 months and 36 months post-embolization
measure: Recanalization Rates by Modality (LOBO vs conventional)
timeFrame: 6, 12, and 36-months post-embolization
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Nima Kokabi, MD
role: PRINCIPAL_INVESTIGATOR
References: