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Microvascular Plug (MVP) for the Treatment of Pulmonary ArterioVenous Malformations (PAVMs)

Microvascular Plug (MVP) for the Treatment of Pulmonary ArterioVenous Malformations (PAVMs)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04396041
Enrollment
223
Registered
2020-05-20
Start date
2018-09-01
Completion date
2023-01-31
Last updated
2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arteriovenous Malformation

Keywords

Pulmonary Arteriovenous Malformation, PAVM, HHT, hereditary hemorrhagic telangiectasia

Brief 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. 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.

Interventions

DEVICEMicrovascular Plug (MVP)

Patient's Pulmonary AVM(s) treated via transcatheter embolization with Microvascular Plugs.

DEVICEAmplatzer Vascular Plug (AVP)

Patient's Pulmonary AVM(s) treated via transcatheter embolization with Amplatzer Vascular Plugs.

DEVICEDetachable coils

Patient's Pulmonary AVM(s) treated via transcatheter embolization with detachable coils.

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Undergoing embolization of Pulmonary Arteriovenous Malformation (PAVM)

Exclusion criteria

* PAVM unable to be embolized

Design outcomes

Primary

MeasureTime frameDescription
Reperfusion RatesUp to 3 YearsAnalyzed 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 successImmediately after procedure up to 5 minutesImmediate post-procedural technical success defined as complete occlusion of the feeding artery supplying the PAVM.

Secondary

MeasureTime frameDescription
Contrast doseUp to 4 hoursContrast dose in mL.
Cost of embolic device per PAVMUp to 4 hoursThe number of embolic used per procedure will be used to determine the cost per PAVM.
Procedure durationUp to 4 hoursDuration of procedure in minutes.
Radiation Dose Area Product (DAP)Up to 4 hoursRadiation DAP measured in milligray-centimeters squared (mGy-cm\^2).
Cumulative Air Kerma (AK) doseUp to 4 hoursCumulative Air Kerma dose measured in milligray (mGy).
Overall procedure cost for PAVMUp to 1 weekOverall procedure cost for PAVM will be determined at 1 week after the procedure.
Fluoroscopy timeUp to 4 hoursFluoroscopy time measured in minutes.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026