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

Conditions

• Pulmonary Arteriovenous Malformations

Eligibility Criteria

Sex

ALL

Age

14 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PAVM Embolization — DEVICE
  This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.
• PAVM Embolization with a LOBO™ device — DEVICE
  Participants will undergo PAVM embolization with the LOBO™ device per standard of care.

Study Details

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.

Key Dates

Start date

Dec 17, 2024

Status verified

Feb 2026

Primary completion

Dec 31, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: PAVM Embolization
  This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.

Primary Outcome Measure

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

Central Contacts

• Markeela Lipscomb
  919-843-3670
  [email protected]
• Desma Jones
  919-843-9463
  [email protected]

Locations (1)

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