MAX-PIPE Registry - Maximizing Flow Diversion Effect On The Treatment of Large Intracranial Aneurysms With PIPEline Flex Embolization Devices Using Optical Flow Imaging Software "AneurysmFlow"
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of participants with complete aneurysm occlusion at 12 months based on contrast agent volume measurement in angiography.
研究概览
简要总结
Investigate the ability of the intra-operative, intra-aneurysmal flow evaluation to assist with the treatment of intracranial large aneurysms using Embolization Device(s)
详细描述
The Division of Neuroradiology at UHN (Toronto Western Hospital) would like to initiate a single center registry study on the treatment of large intracranial aneurysms with PIPEline[tm] flex embolization devices using optical flow imaging software, "AneurysmFlow". The study team will consent patients diagnosed with unruptured brain / intracratial aneurysms IA(s) . The selected patients ,who booked for elective brain aneurysm repair/endovascular treatment with Flow diverter devices (FDS) called Pipeline embolization devices (PED), will qualify for registry participation . During the PED procedure, the study team will be using AneurysmFlow software to calculate a new metric called the MAFA ratio (Mean Aneurysm Flow Amplitude). By calculating the MAFA ratios intra-operatively, the interventionalist can adapt the therapeutic strategy in order to maximize the flow diverting effect on inducing complete aneurysm occlusions (thrombosis). Additionally, the purpose of this study is to further expand the body of clinical knowledge concerning the relationship between blood flow metrics as determined by the AneurysmFlow software and clinical outcome in patients undergoing treatment for intracranial aneurysms (IAs) with Pipeline and Pipeline Flex embolization devices. The study team aims to collect data at a 12 month follow-up period for each patient
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with unruptured, large (≥8mm) saccular aneurysm(s) located in the anterior intracranial circulation and suitable for an endovascular treatment with a Flow Diverter Stent.
- •Subject has signed an institutionally approved research informed consent form.
- •Subject ≥ 18 years old.
排除标准
- •Subject with non-saccular brain aneurysm (s) such as:- dissecting; fusiform; atherosclerotic; mycotic; bifurcational.
- •Subject underwent a prior target brain aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques.
- •The endovascular treatment of subject's target aneurysm(s) was assisted with coils or intracranial stents (non-FDS) before the AneurysmFlow calculations.
- •Subject with partially thrombosed or recanalized target brain aneurysm(s).
- •Subject had prior significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.
- •Subject with severe kidney disease (e-GFR < 60).
- •Subject is not willing (or not able) to attend post FDS insertion follow up clinic visits requiring DSA, head MRI or CTA imaging.
结局指标
主要结局
Number of participants with complete aneurysm occlusion at 12 months based on contrast agent volume measurement in angiography.
时间窗: 1 year
≥86% complete aneurysm occlusion rate after 12 months post-treatment using optical flow analysis with a MAFA threshold ratio of 0.89, measured with an image processing tool.
次要结局
- High sensitivity and specificity (> 80%) of the MAFA ratio to determine aneurysm occlusion rates based on ROC statistical calculations.(1 year)
- Number of participants with treatment complications as assessed by an electronic patient record.(1 year)
- Number of participants with complete aneurysm occlusion at 6 months based on contrast agent volume measurement in angiography.(6 months)
研究者
Vitor Pereira
Associate Professor of Radiology and Surgery
University Health Network, Toronto