LOBO™ Device for Pulmonary Arteriovenous Malformations

(PAVM Trial)

Overseen By Desma Jones

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Anti-platelets, Anti-coagulation

Disqualifiers: Bleeding disorders, Iodinated contrast allergy, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that patients not be on anti-platelets or anti-coagulation medications, so you may need to stop these if you are taking them.

What data supports the effectiveness of the LOBO™ Vascular Occlusion Device treatment for pulmonary arteriovenous malformations?

The LOBO™ Vascular Occlusion Device was used successfully in a small study to treat pulmonary arteriovenous malformations in four patients, showing complete blockage of blood flow in the treated areas without any major complications. This early experience suggests the device is safe and effective, but more research with larger groups is needed to confirm these results. ^{1 2 3 4 5}

Is the LOBO™ Device safe for treating pulmonary arteriovenous malformations?

The LOBO™ Device has been used safely in a small study involving 4 patients with pulmonary arteriovenous malformations, showing no severe adverse events or device migrations. Further studies with more participants and longer follow-up are needed to confirm its safety. ^{1 6 7 8 9}

How is the LOBO™ Vascular Occlusion Device treatment different from other treatments for pulmonary arteriovenous malformations?

The LOBO™ Vascular Occlusion Device is unique because it is a low-profile, high-density braided occluder specifically designed for embolization (blocking blood flow) of pulmonary arteriovenous malformations, offering a safe and effective alternative with no severe adverse events or device migrations reported in early studies. ^{1 2 4 5 10}

What is the purpose of this trial?

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.

Research Team

Nima Kokabi, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for individuals with conditions like Pulmonary Arteriovenous Malformations (PAVM), Placental Chorioangioma, and related genetic disorders. Participants will undergo an embolization procedure using the LOBO™ device and must be able to attend four study visits over 36 months.

Inclusion Criteria

Per standard of care (SOC), all pregnant women to be enrolled must be in their 2nd or 3rd trimesters

I have a lung blood vessel abnormality suitable for a specific treatment.

I have multiple PAVMs eligible for treatment with the LOBO device in one or more sessions.

Exclusion Criteria

I have a blood clotting disorder.

I have a severe allergy to iodine-based contrast that can't be managed with steroids.

I do not have any bleeding disorders except for HHT.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PAVM embolization with the LOBO™ device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

3 visits (in-person) at 6, 12, and 36 months

Treatment Details

Interventions

• LOBO™ Vascular Occlusion Device

Trial Overview The trial tests the effectiveness of the LOBO™ Vascular Occlusion Device in PAVM embolization. It measures technical success, number of devices needed, time to occlusion, and compares short-term to long-term occlusion rates against conventional methods.

Participant Groups

Group I: PAVM Embolization Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Okami Medical, Inc.

Collaborator

Trials

1

Recruited

30+

Findings from Research

The low-profile braided occluder (LOBO) was successfully used to embolize pulmonary arteriovenous malformations (PAVMs) in 4 patients, with complete cessation of blood flow achieved in all treated vessels without any severe adverse events.

Short-term follow-up showed that all occluders maintained complete occlusion of the PAVMs for a median of 7 months, indicating both safety and early effectiveness of this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Experience with a Low-Profile High-Density Braid Occluder for Transcatheter Embolization of Pulmonary Arteriovenous Malformations. Yu, Q., Zangan, S., Funaki, B.[2023]

A large pulmonary arteriovenous malformation was effectively treated by occlusion using multiple Gianturco-Grifka vascular occlusion devices, demonstrating the efficacy of this intervention.

The successful retrieval of a protruding filler wire three weeks post-implantation highlights the safety and manageability of complications associated with this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closure of a large pulmonary arteriovenous malformation using multiple Gianturco-Grifka vascular occlusion devices. Ebeid, MR., Braden, DS., Gaymes, CH., et al.[2019]

A 26-year-old man with a giant pulmonary arteriovenous malformation (PAVM) successfully underwent transcatheter embolization using two Cardioseal double umbrella devices, demonstrating that this method is effective for large PAVMs.

The procedure was technically straightforward, had no complications, and resulted in sustained improvements in arterial saturation and exercise tolerance, suggesting it is a safe and viable treatment option for large PAVMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter occlusion of a large pulmonary arteriovenous malformation with use of a Cardioseal device. Apostolopoulou, SC., Kelekis, NL., Papagiannis, J., et al.[2019]

The use of an Amplatzer vascular plug for occluding a pulmonary arteriovenous fistula in a patient with Rendu-Osler-Weber syndrome demonstrates a promising alternative to traditional embolotherapy methods, which can risk complications like paradoxical embolism.

This case highlights the potential safety and efficacy of the Amplatzer vascular plug in treating pulmonary arteriovenous malformations, particularly in cases where conventional coils or balloons may pose a higher risk of migration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Occlusion of a pulmonary arteriovenous fistula with an amplatzer vascular plug]. Baldi, S., Rostagno, RD., Zander, T., et al.[2019]

Transcatheter closure of pulmonary arteriovenous malformations (PAVMs) using Amplatzer devices was successful in all five patients studied, leading to a significant increase in oxygen saturation from 88.4% to 96.4%.

The procedure was safe, with no complications reported during or after the treatment, and all patients remained free of embolic phenomena or infections at a median follow-up of 3.4 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter closure of pulmonary arteriovenous malformations with amplatzer devices. Beck, A., Dagan, T., Matitiau, A., et al.[2016]

The Mynx vascular-closure device was found to have a significantly higher risk of vascular complications compared to alternative devices, with a relative risk of 1.59 based on an analysis of 73,124 patients after PCI procedures.

Active surveillance of a national clinical registry effectively identified safety concerns within the first year, highlighting the importance of ongoing monitoring for medical devices to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Registry-Based Prospective, Active Surveillance of Medical-Device Safety. Resnic, FS., Majithia, A., Marinac-Dabic, D., et al.[2022]

A new stainless-steel spider device for transcatheter vessel occlusion allows for accurate placement and retrieval, enhancing its usability in medical procedures.

In tests conducted on dogs, the device effectively occluded vessels in the aorta and pulmonary artery, proving particularly beneficial for blocking large arteriovenous fistulas in the lungs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detachable stainless-steel spider. A new device for vessel occlusion. Lund, G., Cragg, AH., Rysavy, JA., et al.[2003]

The Gianturco-Grifka vascular occlusion device (GGVOD) was successfully used to occlude arteries and aortopulmonary shunts in a canine model, demonstrating effectiveness for vessels ranging from 3 to 9 mm in diameter.

GGVOD implantation was efficient, requiring a mean fluoroscopic time of only 9 minutes, which suggests it could be a practical option for various cardiovascular defects in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Gianturco-Grifka vascular occlusion device. Initial studies in a canine model. Grifka, RG., Mullins, CE., Gianturco, C., et al.[2019]

Percutaneous transcatheter coil embolization effectively reduces right-to-left shunt fraction and improves arterial oxygen saturation in patients with pulmonary arteriovenous malformations, with 33% of patients achieving normal oxygen levels post-procedure.

The procedure is well tolerated, with a low complication rate of 13% across 93 procedures, indicating it is a safe intervention for managing these malformations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary arteriovenous malformations: effect of embolization on right-to-left shunt, hypoxemia, and exercise tolerance in 66 patients. Gupta, P., Mordin, C., Curtis, J., et al.[2022]

The Amplatzer vascular plug is a new and effective device for treating pulmonary arteriovenous malformations, particularly in large high-flow vessels, as it allows for quick and safe positioning and repositioning before final delivery.

Two successful cases demonstrated the efficacy of the Amplatzer vascular plug in embolizing large pulmonary arteriovenous malformations, highlighting its potential as a reliable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occlusion of pulmonary arteriovenous malformations by use of vascular plug. Andersen, PE., Kjeldsen, AD.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preliminary Experience with a Low-Profile High-Density Braid Occluder for Transcatheter Embolization of Pulmonary Arteriovenous Malformations. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Closure of a large pulmonary arteriovenous malformation using multiple Gianturco-Grifka vascular occlusion devices. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Transcatheter occlusion of a large pulmonary arteriovenous malformation with use of a Cardioseal device. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

[Occlusion of a pulmonary arteriovenous fistula with an amplatzer vascular plug]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Transcatheter closure of pulmonary arteriovenous malformations with amplatzer devices. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Registry-Based Prospective, Active Surveillance of Medical-Device Safety. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Detachable stainless-steel spider. A new device for vessel occlusion. [2003]

8. United States pubmed.ncbi.nlm.nih.gov

New Gianturco-Grifka vascular occlusion device. Initial studies in a canine model. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Pulmonary arteriovenous malformations: effect of embolization on right-to-left shunt, hypoxemia, and exercise tolerance in 66 patients. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Occlusion of pulmonary arteriovenous malformations by use of vascular plug. [2016]