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

NCT ID: NCT04396041

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 223 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2023-01-31

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.

Conditions

Pulmonary Arteriovenous Malformation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Microvascular Plug (MVP)

Intervention Type: DEVICE

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

Amplatzer Vascular Plug (AVP)

Intervention Type: DEVICE

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

Detachable coils

Intervention Type: DEVICE

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

Interventions

Microvascular Plug (MVP)

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

Intervention Type: DEVICE

Amplatzer Vascular Plug (AVP)

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

Intervention Type: DEVICE

Detachable coils

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Undergoing embolization of Pulmonary Arteriovenous Malformation (PAVM)

Exclusion Criteria

• PAVM unable to be embolized

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clifford R Weiss, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00173822

Identifier Type: -

Identifier Source: org_study_id