Using the LOBO™ device for treating Pulmonary Arteriovenous Malformations
Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations (PAVM)
This study is testing if the LOBO™ device can safely and effectively treat people with Pulmonary Arteriovenous Malformations by blocking off the abnormal blood vessels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06735976 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of the LOBO™ vascular occlusion device in patients undergoing embolization for Pulmonary Arteriovenous Malformations (PAVMs). It aims to determine the technical success rate, the number of devices needed for occlusion, and the time to occlusion for each feeding artery. Participants will be monitored for short-term, medium-term, and long-term occlusion rates over a period of 36 months. The study involves a single-center approach with 30 participants who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with at least one PAVM that has a feeding artery of 2 mm or larger and is suitable for embolization with the LOBO™ device.
Not a fit: Patients with confounding bleeding disorders, life-threatening allergies to iodinated contrast, or underlying coagulopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with PAVMs, potentially reducing the risk of complications associated with the condition.
How similar studies have performed: While this approach is novel in using the LOBO™ device specifically for PAVMs, similar embolization techniques have shown success in treating other vascular malformations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Nima Kokabi, MD — University of North Carolina, Chapel Hill
- Study coordinator: Markeela Lipscomb
- Email: markeela_lipscomb@med.unc.edu
- Phone: 919-843-3670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.