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临床试验/NCT04396041
NCT04396041已完成不适用

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

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 223 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
223
试验地点
1
主要终点
Reperfusion Rates

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Undergoing embolization of Pulmonary Arteriovenous Malformation (PAVM)

排除标准

  • PAVM unable to be embolized

结局指标

主要结局

Reperfusion Rates

时间窗: 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.

Immediate post-procedural success

时间窗: Immediately after procedure up to 5 minutes

Immediate post-procedural technical success defined as complete occlusion of the feeding artery supplying the PAVM.

次要结局

  • Cost of embolic device per PAVM(Up to 4 hours)
  • Fluoroscopy time(Up to 4 hours)
  • Overall procedure cost for PAVM(Up to 1 week)
  • Radiation Dose Area Product (DAP)(Up to 4 hours)
  • Procedure duration(Up to 4 hours)
  • Contrast dose(Up to 4 hours)
  • Cumulative Air Kerma (AK) dose(Up to 4 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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