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

NCT06735976 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-17

No results posted yet for this 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.

Conditions

  • Pulmonary Arteriovenous Malformations

Interventions

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.

Sponsors & Collaborators

  • Okami Medical, Inc.

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Nima Kokabi, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06735976 on ClinicalTrials.gov