Pulmonary Arteriovenous MalformationsPAVMNCT06735976
Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations
A study testing PAVM Embolization and PAVM Embolization with a LOBO™ device in people with Pulmonary Arteriovenous Malformations, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pulmonary Arteriovenous Malformations
- What is being tested?
- PAVM Embolization and PAVM Embolization with a LOBO™ device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2024to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations (PAVM)
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)?
Read more
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.
Read the 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.
- Conditions
- Pulmonary Arteriovenous Malformations
- Being tested
- PAVM Embolization, PAVM Embolization with a LOBO™ device
- Keywords
- Embolization, Pulmonary Arteriovenous Malformations, PAVM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAVM EmbolizationDevice
This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.
PAVM Embolization with a LOBO™ deviceDevice
Participants will undergo PAVM embolization with the LOBO™ device per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| PAVM Embolization | Other | This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device. Receives: Device: PAVM Embolization; Device: PAVM Embolization with a LOBO™ device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Technical Success
Technical success will be defined as the successful deployment of the LOBO™ device in the intended vessel and complete occlusion of the vessel. Successful deployment will be defined as 1) no technical malfunctions in the LOBO™ deployment system that leads to an inability to deploy the device and 2) deployment of the device into the intended vessel and not into surrounding vessels. Complete occlusion will be defined as complete cessation of blood flow through the embolized vessel based on intraprocedural angiography.
Measured: At treatment until stasis is achieved. Approximately 1 - 2 hours.
Secondary outcomes (5)
Mean Number of LOBO Plugs
Descriptive statistics for the number of LOBO™ devices needed for technical success will be reported.
Measured: At treatment until stasis is achieved. Approx. 1 - 2 hours.
Mean Time to Complete Occlusion
Descriptive statistics for the time to completion will be reported.
Measured: At treatment until stasis is achieved. Approx. 1 - 2 hours.
Short-term Occlusion Rate
Recanalization will be defined as contrast visualization through the plug or the aneurysmal sac on follow-up CTA's. Interpretation of these images will be done by standard clinical radiologists and not research personnel. The reading radiologist's interpretation will be used to determine if recanalization has occurred.
Measured: 6 months post-embolization
Medium- and Long-term Occlusion Rates
Recanalization will be defined as contrast visualization through the plug or the aneurysmal sac on follow-up CTA's. Interpretation of these images will be done by standard clinical radiologists and not research personnel. The reading radiologist's interpretation will be used to determine if recanalization has occurred.
Measured: 12 months and 36 months post-embolization
Recanalization Rates by Modality (LOBO vs conventional)
Proportion of LOBO™ embolized PAVMs that develop recanalization at 6, 12, and 36- month intervals compared to proportion of conventionally embolized PAVMs (those embolized with coils, Amplatzer, MVPs) that develop recanalization at the same intervals. The retrospective comparator group will consist of patients who have undergone conventional embolization at UNC in a separate trial.
Measured: 6, 12, and 36-months post-embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start17 Dec 2024
- Primary completion22 May 2026
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arteriovenous MalformationsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Okami Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Nima Kokabi, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735976
- Sponsor's protocol ID
- 24-2233
- Acronym
- PAVM
- Status last verified
- Nov 2026
- First submitted
- 11 Dec 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations (PAVM)
- ClinicalTrials.gov ID
- NCT06735976
- Acronym / sponsor ID
- PAVM / 24-2233
- Conditions
- Pulmonary Arteriovenous Malformations
- Keywords
- Embolization, Pulmonary Arteriovenous Malformations, PAVM
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Okami Medical, Inc.
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- May 2029 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAVM Embolization | Other | Device: PAVM Embolization, Device: PAVM Embolization with a LOBO™ deviceThis study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAVM EmbolizationThis study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device. | Device | PAVM Embolization |
| PAVM Embolization with a LOBO™ deviceParticipants will undergo PAVM embolization with the LOBO™ device per standard of care. | Device | PAVM Embolization |
Primary outcome
Proportion of Technical Success
Time frame: At treatment until stasis is achieved. Approximately 1 - 2 hours.
Technical success will be defined as the successful deployment of the LOBO™ device in the intended vessel and complete occlusion of the vessel. Successful deployment will be defined as 1) no technical malfunctions in the LOBO™ deployment system that leads to an inability to deploy the device and 2) deployment of the device into the intended vessel and not into surrounding vessels. Complete occlusion will be defined as complete cessation of blood flow through the embolized vessel based on intraprocedural angiography.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nima Kokabi, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAVM Embolization and PAVM Embolization with a LOBO™ device in people with Pulmonary Arteriovenous Malformations, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Technical Success (time frame: At treatment until stasis is achieved. Approximately 1 - 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.