RECRUITING

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

Conditions

Pulmonary Arteriovenous Malformations Embolization PAVM

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-12-17

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06735976

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.

Ages Eligible for Study:14 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Markeela Lipscomb

CONTACT

919-843-3670

markeela_lipscomb@med.unc.edu

Desma Jones

CONTACT

919-843-9463

desma_jones@med.unc.edu

Principal Investigator

Nima Kokabi, MD

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-17

Study Completion Date2029-12

Study Record Updates

Study Start Date2024-12-17

Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

Embolization
Pulmonary Arteriovenous Malformations
PAVM

Additional Relevant MeSH Terms

Pulmonary Arteriovenous Malformations