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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arteriovenous Malformations
• Intervention / Treatment: Device: PAVM Embolization; Device: PAVM Embolization with a LOBO™ device

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Markeela Lipscomb; Phone Number: 919-843-3670; Email: markeela_lipscomb@med.unc.edu
• Study Contact Backup: Name: Desma Jones; Phone Number: 919-843-9463; Email: desma_jones@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Desma Jones; Phone Number: 919-843-9463; Email: desma_jones@med.unc.edu
      • Contact: Markeela Lipscomb; Phone Number: (919) 843-3670; Email: markeela_lipscomb@med.unc.edu
      • Principal Investigator: Nima Kokabi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PAVM Embolization; This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.	Device: PAVM Embolization; This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.; Device: PAVM Embolization with a LOBO™ device; Participants will undergo PAVM embolization with the LOBO™ device per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Technical Success	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Number of LOBO Plugs	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	Descriptive statistics for the time to completion will be reported.	At treatment until stasis is achieved. Approx. 1 - 2 hours.
Short-term Occlusion Rate	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	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)	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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Okami Medical, Inc.
• Investigators: Principal Investigator: Nima Kokabi, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Embolization; PAVM; Pulmonary Arteriovenous Malformations
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Pathological Conditions, Anatomical; Neoplasms by Histologic Type; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Vascular Malformations; Fistula; Vascular Fistula; Congenital Abnormalities; Arteriovenous Malformations; Arteriovenous Fistula; Hemangioma
• Other Study ID Numbers: 24-2233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 9 and continuing for 36 months following publication.
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No