Pulmonary Arteriovenous MalformationNCT04396041
Microvascular Plug (MVP) for the Treatment of Pulmonary ArterioVenous Malformations (PAVMs)
An observational study of Pulmonary Arteriovenous Malformation, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to compare the use of the Micro Vascular Plug (MVP) system and other embolic devices in treatment of PAVMs. Pulmonary Arteriovenous Malformations (PAVMs) are abnormal connections between the pulmonary vein and the pulmonary artery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Arteriovenous Malformation
- What is being tested?
- Microvascular Plug (MVP), Amplatzer Vascular Plug (AVP) and Detachable coils
- Type of treatment
- Medical device
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Jan 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Pulmonary Arteriovenous Malformation (PAVM) being treated through the Interventional Radiology clinic.
Who may be able to join
- Undergoing embolization of Pulmonary Arteriovenous Malformation (PAVM)
Who cannot join
- PAVM unable to be embolized
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the use of the Micro Vascular Plug (MVP) system and other embolic devices in treatment of PAVMs. Pulmonary Arteriovenous Malformations (PAVMs) are abnormal connections between the pulmonary vein and the pulmonary artery. This affects blood flow between the heart and lungs which puts patients at risk of stroke, brain abscess, hypoxia and even sudden death. The standard treatment of PAVMs is embolization. Embolization is the placing of an embolic (synthetic agent) into a blood vessel to block blood flow. The embolic is inserted via a catheter into the blood vessel. Detachable coils are the most commonly used embolic in the treatment of PAVMs. Despite long procedure times, numerous coils that are often required to occlude a single PAVM and recanalization rates ranging from 5% to 15%, the most widely used embolic device is still the detachable coil.
Read the detailed description
Transcatheter embolization has become the standard of care in the treatment of Pulmonary Arteriovenous Malformations (PAVMs). PAVM embolization is performed to prevent right to left shunting which puts patients at risk of stroke, brain abscess, hypoxia and even sudden death. Despite long procedure times, numerous coils that are often required to occlude a single PAVM and recanalization rates ranging from 5% to 15%, the most widely used embolic device is still the detachable coil delivered through a microcatheter. An alternative to coil embolization is the Amplatzer Vascular plug (AVP). AVPs allow for quick delivery of a single occluding device. AVPs, however, cannot be delivered through a microcatheter, limiting the AVPs' utility to larger PAVM with larger feeding arteries. The new MVPTM Micro Vascular Plug System (MVP, Medtronic) was designed to combine the best of both devices and allows for the occlusion of small vessels in a quick and predictable manner with a single embolic device through a micro catheter. At the investigators' institution the investigators have a very large PAVM practice, as the investigators are a large Hereditary Hemorrhagic Telangiectasia (HHT) center of excellence. Currently there is a paucity of data comparing these devices for the treatment of PAVMs. Specifically, there is little data to inform interventional radiologists' decision making process about which device to choose based on the patient's clinical characteristics, the size of the PAVM feeding artery, and cost.
The investigators will create a registry/database of all patients who undergo embolization for Pulmonary AVM at the investigators' HHT center of excellence collecting data and adding in data from the investigators' existing PAVM database dating back at least the last 7 years. Patients with MVP embolizations will be assessed and compared to patients who are embolized with other solid embolic devices (coils/plugs). The investigators will assess reperfusion rates, immediate technical success, procedural attributes including procedure time, fluoroscopy time, contrast administration, and finally embolic and overall procedural costs.
- Conditions
- Pulmonary Arteriovenous Malformation
- Being tested
- Microvascular Plug (MVP), Amplatzer Vascular Plug (AVP), Detachable coils
- Keywords
- Pulmonary Arteriovenous Malformation, PAVM, HHT, hereditary hemorrhagic telangiectasia
- Medical subject headings
- Pulmonary Arteriovenous Fistulas, Telangiectasia, Hereditary Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microvascular Plug (MVP)Device
Patient's Pulmonary AVM(s) treated via transcatheter embolization with Microvascular Plugs.
Amplatzer Vascular Plug (AVP)Device
Patient's Pulmonary AVM(s) treated via transcatheter embolization with Amplatzer Vascular Plugs.
Detachable coilsDevice
Patient's Pulmonary AVM(s) treated via transcatheter embolization with detachable coils.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for Pulmonary Arteriovenous Malformation | All participants in the study will be patients who have been treated for Pulmonary Arteriovenous Malformation using Microvascular Plugs, Amplatzer Vascular Plugs or Detachable coils. Receives: Device: Microvascular Plug (MVP); Device: Amplatzer Vascular Plug (AVP); Device: Detachable coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reperfusion Rates
Analyzed at 1 year and 3 years. Based on the investigators' preliminary data, reperfusion has been seen at 1-2 years in the patients the investigators have treated with coils and AVP making the 3-year goal for the investigators' prospective analysis feasible to cover reperfusion.
Measured: Up to 3 Years
Immediate post-procedural success
Immediate post-procedural technical success defined as complete occlusion of the feeding artery supplying the PAVM.
Measured: Immediately after procedure up to 5 minutes
Secondary outcomes (7)
Procedure duration
Duration of procedure in minutes.
Measured: Up to 4 hours
Fluoroscopy time
Fluoroscopy time measured in minutes.
Measured: Up to 4 hours
Contrast dose
Contrast dose in mL.
Measured: Up to 4 hours
Cost of embolic device per PAVM
The number of embolic used per procedure will be used to determine the cost per PAVM.
Measured: Up to 4 hours
Overall procedure cost for PAVM
Overall procedure cost for PAVM will be determined at 1 week after the procedure.
Measured: Up to 1 week
Radiation Dose Area Product (DAP)
Radiation DAP measured in milligray-centimeters squared (mGy-cm^2).
Measured: Up to 4 hours
Cumulative Air Kerma (AK) dose
Cumulative Air Kerma dose measured in milligray (mGy).
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Sep 2018
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arteriovenous MalformationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 223 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clifford R Weiss, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396041
- Sponsor's protocol ID
- IRB00173822
- Status last verified
- Jan 2023
- First submitted
- 15 May 2020
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Plug (MVP) for the Treatment of Pulmonary ArterioVenous Malformations (PAVMs)
- ClinicalTrials.gov ID
- NCT04396041
- Acronym / sponsor ID
- IRB00173822
- Conditions
- Pulmonary Arteriovenous Malformation
- Keywords
- Pulmonary Arteriovenous Malformation, PAVM, HHT, hereditary hemorrhagic telangiectasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 20 May 2020 (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 purpose of this study is to compare the use of the Micro Vascular Plug (MVP) system and other embolic devices in treatment of PAVMs. Pulmonary Arteriovenous Malformations (PAVMs) are abnormal connections between the pulmonary vein and the pulmonary artery. This affects blood flow between the heart and lungs which puts patients at risk of stroke, brain abscess, hypoxia and even sudden death. The standard treatment of PAVMs is embolization. Embolization is the placing of an embolic (synthetic agent) into a blood vessel to block blood flow. The embolic is inserted via a catheter into the blood vessel. Detachable coils are the most commonly used embolic in the treatment of PAVMs. Despite long procedure times, numerous coils that are often required to occlude a single PAVM and recanalization rates ranging from 5% to 15%, the most widely used embolic device is still the detachable coil.
Detailed description
Transcatheter embolization has become the standard of care in the treatment of Pulmonary Arteriovenous Malformations (PAVMs). PAVM embolization is performed to prevent right to left shunting which puts patients at risk of stroke, brain abscess, hypoxia and even sudden death. Despite long procedure times, numerous coils that are often required to occlude a single PAVM and recanalization rates ranging from 5% to 15%, the most widely used embolic device is still the detachable coil delivered through a microcatheter. An alternative to coil embolization is the Amplatzer Vascular plug (AVP). AVPs allow for quick delivery of a single occluding device. AVPs, however, cannot be delivered through a microcatheter, limiting the AVPs' utility to larger PAVM with larger feeding arteries. The new MVPTM Micro Vascular Plug System (MVP, Medtronic) was designed to combine the best of both devices and allows for the occlusion of small vessels in a quick and predictable manner with a single embolic device through a micro catheter. At the investigators' institution the investigators have a very large PAVM practice, as the investigators are a large Hereditary Hemorrhagic Telangiectasia (HHT) center of excellence. Currently there is a paucity of data comparing these devices for the treatment of PAVMs. Specifically, there is little data to inform interventional radiologists' decision making process about which device to choose based on the patient's clinical characteristics, the size of the PAVM feeding artery, and cost.
The investigators will create a registry/database of all patients who undergo embolization for Pulmonary AVM at the investigators' HHT center of excellence collecting data and adding in data from the investigators' existing PAVM database dating back at least the last 7 years. Patients with MVP embolizations will be assessed and compared to patients who are embolized with other solid embolic devices (coils/plugs). The investigators will assess reperfusion rates, immediate technical success, procedural attributes including procedure time, fluoroscopy time, contrast administration, and finally embolic and overall procedural costs.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for Pulmonary Arteriovenous Malformation | – | Device: Microvascular Plug (MVP), Device: Amplatzer Vascular Plug (AVP), Device: Detachable coilsAll participants in the study will be patients who have been treated for Pulmonary Arteriovenous Malformation using Microvascular Plugs, Amplatzer Vascular Plugs or Detachable coils. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Pulmonary Arteriovenous Malformation (PAVM) being treated through the Interventional Radiology clinic.
Key inclusion criteria (1 listed)
- Undergoing embolization of Pulmonary Arteriovenous Malformation (PAVM)
Key exclusion criteria (1 listed)
- PAVM unable to be embolized
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 |
|---|---|---|
| Microvascular Plug (MVP)Patient's Pulmonary AVM(s) treated via transcatheter embolization with Microvascular Plugs. | Device | Patients treated for Pulmonary Arteriovenous Malformation |
| Amplatzer Vascular Plug (AVP)Patient's Pulmonary AVM(s) treated via transcatheter embolization with Amplatzer Vascular Plugs. | Device | Patients treated for Pulmonary Arteriovenous Malformation |
| Detachable coilsPatient's Pulmonary AVM(s) treated via transcatheter embolization with detachable coils. | Device | Patients treated for Pulmonary Arteriovenous Malformation |
Primary outcome
Reperfusion Rates
Time frame: Up to 3 Years
Analyzed at 1 year and 3 years. Based on the investigators' preliminary data, reperfusion has been seen at 1-2 years in the patients the investigators have treated with coils and AVP making the 3-year goal for the investigators' prospective analysis feasible to cover reperfusion.
Immediate post-procedural success
Time frame: Immediately after procedure up to 5 minutes
Immediate post-procedural technical success defined as complete occlusion of the feeding artery supplying the PAVM.
7 secondary outcomes
Procedure duration
Time frame: Up to 4 hours
Fluoroscopy time
Time frame: Up to 4 hours
Contrast dose
Time frame: Up to 4 hours
Cost of embolic device per PAVM
Time frame: Up to 4 hours
Overall procedure cost for PAVM
Time frame: Up to 1 week
Radiation Dose Area Product (DAP)
Time frame: Up to 4 hours
Cumulative Air Kerma (AK) dose
Time frame: Up to 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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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.
Clifford R Weiss, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arteriovenous Malformation, run by Johns Hopkins University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reperfusion Rates (time frame: Up to 3 Years). The study lists 2 primary outcomes in all. 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 1 Feb 2023.