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

Official title

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

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.

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.

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.

Primary outcome measures

• Proportion of Technical Success [Time frame: At treatment until stasis is achieved. Approximately 1 - 2 hours.]

Secondary outcome measures (5)

• Mean Number of LOBO Plugs [Time frame: At treatment until stasis is achieved. Approx. 1 - 2 hours.]
• Mean Time to Complete Occlusion [Time frame: At treatment until stasis is achieved. Approx. 1 - 2 hours.]
• Short-term Occlusion Rate [Time frame: 6 months post-embolization]
• Medium- and Long-term Occlusion Rates [Time frame: 12 months and 36 months post-embolization]
• Recanalization Rates by Modality (LOBO vs conventional) [Time frame: 6, 12, and 36-months post-embolization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of North Carolina at Chapel Hill — Chapel Hill

Identifiers

NCT: NCT06735976 · 24-2233

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗