Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04396041 |
| Other study ID # |
IRB00173822 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2018 |
| Est. completion date |
January 31, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
