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

NCT06735976 | Recruiting FDA Device

• 1 other identifier: 24-2233
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arteriovenous Malformations

Keywords

Embolization; Pulmonary Arteriovenous Malformations; PAVM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

PAVM Embolization

OTHER

This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.

Device: PAVM Embolization; Device: PAVM Embolization with a LOBO™ device

Interventions

PAVM Embolization DEVICE

This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.

PAVM Embolization

PAVM Embolization with a LOBO™ device DEVICE

Participants will undergo PAVM embolization with the LOBO™ device per standard of care.

PAVM Embolization

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Okami Medical, Inc.: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Study Officials

• Nima Kokabi, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Markeela Lipscomb

CONTACT

919-843-3670; markeela_lipscomb@med.unc.edu

Desma Jones

CONTACT

919-843-9463; desma_jones@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 and continuing for 36 months following publication.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)