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

Phase

N/A

Condition

Abnormal Blood Vessels (Arteriovenous Malformations)

Birth Defects

Hemangioma

Treatment

PAVM Embolization

PAVM Embolization with a LOBO™ device

Clinical Study ID

NCT06735976

24-2233

Ages > 14
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

At least 1 PAVM with a feeding artery ≥2 mm in diameter and a feeding arteryamenable to the use of LOBO™ device (i.e. feeding artery length of ≥1 cm). Given thelength of embolic devices including LOBO™, the proximal vessel length to the PAVMsac must be of sufficient size for embolization to be feasible. If patients have atleast 1 PAVM where the feeding artery length is ≥1 cm, they are eligible forenrollment.
Patients with multiple PAVMs meeting eligibility criteria may be enrolled with theintent of embolizing multiple different PAVMs with the LOBO™ device in the sameembolization 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 2ndor 3rd trimesters

Exclusion

Exclusion Criteria:

Confounding bleeding disorders other than HHT
Life-threatening iodinated contrast allergy not amenable to prophylactic therapywith steroids
Underlying coagulopathy
Patients on anti-platelets or anti-coagulation medications

Study Design

PAVM Embolization

December 17, 2024

December 31, 2029

Study 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.

Connect with a study center

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Active - Recruiting

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