Ignite Creation Date:
2024-05-06 @ 2:41 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04396041
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2020-05-15
Brief Title:
Microvascular Plug MVP for the Treatment of Pulmonary ArterioVenous Malformations PAVMs
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Microvascular Plug MVP for the Treatment of Pulmonary ArterioVenous Malformations PAVMs
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients clinical characteristics the size of the PAVM feeding artery and cost
The investigators will create a registrydatabase 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 coilsplugs 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
The investigators will create a registrydatabase 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 coilsplugs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None