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Completed

NCT Number: NCT04396041

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing embolization of Pulmonary Arteriovenous Malformation (PAVM)

Exclusion criteria

  • PAVM unable to be embolized

Treatment and study plan

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 coils

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Procedure duration

    Time frame: Up to 4 hours

    Duration of procedure in minutes.

  2. Fluoroscopy time

    Time frame: Up to 4 hours

    Fluoroscopy time measured in minutes.

  3. Contrast dose

    Time frame: Up to 4 hours

    Contrast dose in mL.

  4. Cost of embolic device per PAVM

    Time frame: Up to 4 hours

    The number of embolic used per procedure will be used to determine the cost per PAVM.

  5. Overall procedure cost for PAVM

    Time frame: Up to 1 week

    Overall procedure cost for PAVM will be determined at 1 week after the procedure.

  6. Radiation Dose Area Product (DAP)

    Time frame: Up to 4 hours

    Radiation DAP measured in milligray-centimeters squared (mGy-cm^2).

  7. Cumulative Air Kerma (AK) dose

    Time frame: Up to 4 hours

    Cumulative Air Kerma dose measured in milligray (mGy).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 20, 2020
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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