Microvascular Plug (MVP) for the Treatment of Pulmonary ArterioVenous Malformations (PAVMs)
Ключови думи
Резюме
Описание
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.
Дати
Последна проверка: | 04/30/2020 |
Първо изпратено: | 05/14/2020 |
Очаквано записване подадено: | 05/14/2020 |
Първо публикувано: | 05/19/2020 |
Изпратена последна актуализация: | 05/14/2020 |
Последна актуализация публикувана: | 05/19/2020 |
Действителна начална дата на проучването: | 08/31/2018 |
Приблизителна дата на първично завършване: | 12/31/2021 |
Очаквана дата на завършване на проучването: | 12/31/2021 |
Състояние или заболяване
Интервенция / лечение
Device: Patients treated for Pulmonary Arteriovenous Malformation
Device: Patients treated for Pulmonary Arteriovenous Malformation
Device: Patients treated for Pulmonary Arteriovenous Malformation
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
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. | Device: Patients treated for Pulmonary Arteriovenous Malformation Patient's Pulmonary AVM(s) treated via transcatheter embolization with Microvascular Plugs. |
Критерии за допустимост
Полове, допустими за проучване | All |
Метод за вземане на проби | Probability Sample |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - Undergoing embolization of Pulmonary Arteriovenous Malformation (PAVM) Exclusion Criteria: - PAVM unable to be embolized |
Резултат
Първични изходни мерки
1. Reperfusion Rates [Up to 3 Years]
2. Immediate post-procedural success [Immediately after procedure up to 5 minutes]
Вторични изходни мерки
1. Procedure duration [Up to 4 hours]
2. Fluoroscopy time [Up to 4 hours]
3. Contrast dose [Up to 4 hours]
4. Cost of embolic device per PAVM [Up to 4 hours]
5. Overall procedure cost for PAVM [Up to 1 week]
6. Radiation Dose Area Product (DAP) [Up to 4 hours]
7. Cumulative Air Kerma (AK) dose [Up to 4 hours]