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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Condition
Pulmonary Arteriovenous Malformations
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

14 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of North Carolina, Chapel Hill,

Nima Kokabi, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

2029-12