NCT06735976 Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations
| NCT ID | NCT06735976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Pulmonary Arteriovenous Malformations |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-12-17 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Nima Kokabi, MD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06735976 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Pulmonary Arteriovenous Malformations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06735976 currently recruiting?
Yes, NCT06735976 is actively recruiting participants. Contact the research team at markeela_lipscomb@med.unc.edu for enrollment information.
Where is the NCT06735976 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06735976 clinical trial?
NCT06735976 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Nima Kokabi, MD at University of North Carolina, Chapel Hill. The trial plans to enroll 30 participants.